Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches Exenatide approval highlights Amneal’s capabilities in developing GLP-1 injectables BRIDGEWATER, N.J. / Nov 21, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to...Read more
New flexible arrays are lighter, thinner and designed to improve comfort for Optune Gio users ROOT, Switzerland / Nov 21, 2024 / Business Wire / Novocure (NASDAQ: NVCR) announced today that the U.S. Food and Drug Administration (FDA) approved its new Head Flexible Electrode (HFE) transducer arrays for use with Optune Gio® for the treatment of adult patients with glioblastoma multiforme (GBM). Optune Gio is a wearable, portable device...Read more
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2-positive BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial $25M milestone payment to be received from Jazz Pharmaceuticals in relation to the FDA...Read more
Ziihera is the first and only dual HER2-targeted bispecific antibody approved for HER2+ BTC in the U.S. Ziihera received accelerated approval based on results including a 52% objective response rate and median duration of response of 14.9 months as determined by independent central review (ICR) from the HERIZON-BTC-01 clinical trial Company to host investor webcast on Dec. 11, 2024 For U.S. media and investors only DUBLIN, Nov....Read more
Approval based on positive data from the AUGMENT-101 clinical trial, in which Revuforj delivered robust and durable rates of remission in R/R acute leukemia patients with a KMT2A translocation Syndax to host conference call today at 6:00 p.m. ET WALTHAM, Mass., Nov. 15, 2024 /PRNewswire/ -- Syndax Pharmaceuticals (Nasdaq: SNDX) today announced that the U.S. Food and Drug Administration (FDA) has approved Revuforj® (revumenib) as the...Read more
First-ever FDA approval for gene therapy directly administered to the brain Priority review voucher granted Broad label including children and adults PTC pioneers new approach for CNS drug delivery WARREN, N.J., Nov. 13, 2024 /PRNewswire/ -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the U.S. Food and Drug Administration (FDA) accelerated approval of its gene therapy for the treatment of AADC deficiency, the...Read more
AUCATZYL is the first CAR T therapy approved by the FDA with no requirement for a REMS program (Risk Evaluation Mitigation Strategy) Approval based on FELIX clinical trial of obe-cel in adult patients with r/r B-ALL Conference call to be held on November 11 at 08:30 am EST/13:30 pm BST: conference call participants should pre-register using the link at the bottom of this press release LONDON, Nov. 08, 2024 (GLOBE NEWSWIRE) --...Read more
SCOTTSDALE, Ariz., Nov. 04, 2024 (GLOBE NEWSWIRE) -- Journey Medical Corporation (Nasdaq: DERM) (“Journey Medical”), a commercial-stage pharmaceutical company that primarily focuses on selling and marketing U.S. Food and Drug Administration (“FDA”)-approved prescription pharmaceutical products for the treatment of dermatological conditions, today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release...Read more
Scemblix, a new first-line option for adults with CML, is first to show superior efficacy and favorable safety and tolerability profile in a Phase III trial vs. all standard of care (SoC) therapies1-3 Patients on Scemblix also had fewer dose reductions and half the rate of adverse reactions leading to treatment discontinuation1-3 Nearly 50% of CML patients do not meet efficacy milestones (MMR) with current SoC and almost 25% discontinue...Read more
Younger patients in the U.S. can now benefit from Grifols Fibrin Sealant (FS) and its positive effect on surgical outcomes, including a fast time to hemostasis Grifols surgical bleeding management treatments form part of an increasingly robust portfolio of innovative therapeutics enhancing the health and well-being of patients BARCELONA, Spain, Oct. 29, 2024 (GLOBE NEWSWIRE) -- Grifols (MCE:GRF, MCE:GRF.P, NASDAQ:GRFS), a global...Read more
ORLYNVAH™ is the first oral penem approved for use in the U.S. and the second FDA-approved treatment for uUTIs in the past two decades Company to Host Conference Call on Monday, October 28th at 8:30 a.m. EDT DUBLIN and CHICAGO, Oct. 25, 2024 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™...Read more
PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Estradiol Gel, 0.06%. ANI’s Estradiol Gel, 0.06% is the generic version of the reference listed drug (RLD) EstroGel® Gel, 0.06%. "With the FDA approval and...Read more
First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve Now with two pulsed field ablation (PFA) offerings and a portfolio of electrophysiology solutions, Medtronic is shaping the future of arrythmia treatment today GALWAY,...Read more
First and only respiratory syncytial virus (RSV) vaccine indicated for adults younger than 50 Approval based on data from pivotal Phase 3 trial in adults at increased risk of lower respiratory tract disease caused by RSV NEW YORK / Oct 22, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO® (Respiratory Syncytial Virus Vaccine), the company’s bivalent...Read more
Approval of SELARSDI 130 mg/26 mL in a single-dose vial for intravenous infusion expands label to include treatment of adults with Crohn’s disease and ulcerative colitis The FDA previously approved SELARSDI 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection in April 2024 SELARSDI’s U.S. launch for all indications is expected in Q1 2025 REYKJAVIK, Iceland & PARSIPPANY, N.J., Oct. 22, 2024...Read more
Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE® drug delivery technology Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) BRIDGEWATER, N.J. / Oct 21, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq:...Read more
The Only Product of Its Kind Approved for Use in Four Aesthetic Indications: Temporary Improvement in the Appearance of Moderate to Severe Forehead Lines, Frown Lines, Crow's Feet Lines, and Now Platysma Bands in Adults1-5 With this Approval, BOTOX® Cosmetic is the First and Only Aesthetic Neurotoxin Product to Temporarily Improve the Appearance of Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) in...Read more
The new VENTANA CLDN18 (43-14A) RxDx Assay helps fulfil an unmet medical need by enabling clinicians to identify patients with gastric or gastroesophageal junction (GEJ) cancer who may benefit from a targeted treatment option. CLDN18.2 is an emerging biomarker in gastric and GEJ cancers and helps predict the likelihood of response to targeted therapy. As the leader in companion diagnostics, Roche continues to build on its commitment...Read more
LUMRYZ is the only FDA-approved once-at-bedtime oxybate treatment for cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy Granted Orphan Drug Exclusivity in pediatric narcolepsy patients 7 years and older through October 16, 2031 DUBLIN, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a biopharmaceutical company focused on transforming medicines to...Read more
VYALEV™ is the first and only subcutaneous 24-hour continuous infusion of levodopa-based therapy for the treatment of motor fluctuations in advanced Parkinson's disease Adults treated with VYALEV reported superior improvement in "on" time without troublesome dyskinesia, compared to oral immediate-release carbidopa/levodopa1 VYALEV allows for personalized dosing based on individual needs, morning, day and night NORTH CHICAGO, Ill.,...Read more
The first treatment of its kind for metastatic NSCLC, Optune Lua is approved for use concurrently with PD-1/PD-L1 inhibitors or docetaxel in adult patients with metastatic NSCLC who progressed on or after a platinum-based regimen Results of the pivotal Phase 3 LUNAR trial represent the first substantial improvement in median overall survival in more than 8 years for this patient population Optune Lua is a wearable treatment that...Read more
VAUGHAN, Ontario / Oct 14, 2024 / Business Wire / Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced that the U.S. Food and Drug Administration has approved the enVista® Envy™ full range of vision intraocular lens (IOL), which offers a continuous range of vision with excellent dysphotopsia tolerance on the widely used enVista IOL...Read more
HYMPAVZI’s approval is based on Phase 3 study results demonstrating substantial bleed reduction compared to routine prophylaxis and on-demand treatment in eligible patients with hemophilia A or B without inhibitors In the U.S., HYMPAVZI is the first once-weekly subcutaneous prophylactic treatment for eligible people living with hemophilia B, and the first to be administered via a pre-filled pen or syringe for eligible people living with...Read more
Approval is based on Phase III INAVO120 results, showing the ItovebiTM (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting This approval helps address an urgent unmet need in breast cancer for people with a PIK3CA mutation, one of the most commonly mutated genes in HR-positive disease, associated with poor prognosis Itovebi is...Read more
Approval allows for larger field treatment of actinic keratosis (AK) on face and scalp with Ameluz®-PDT using the BF-RhodoLED or the RhodoLED XL lamp Supplemental New Drug Application (sNDA) supported by two Phase 1 safety studies AK is the second most common diagnosis made by dermatologists in the United States1 An estimated 13 million treatments given each year for AK in the US2 WOBURN, Mass., Oct. 07, 2024 (GLOBE NEWSWIRE) --...Read more
Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first and only canine oral parasiticide to protect against six parasites, including fleas, ticks, heartworms, roundworms, hookwormsii and three different species of tapeworm that other brands skip creating a gap in coverageiii Warming temperatures and changing consumer habits have increased parasite pressure and spread across geographies,...Read more
Cologuard Plus™ test raises the performance bar with sensitivities of 95% for colorectal cancer and 43% for advanced precancerous lesions at 94% specificity Cologuard Plus test will minimize unnecessary follow-up colonoscopies by reducing the likelihood of a false-positive screening test Company expects to launch Cologuard Plus test with Medicare coverage and guideline inclusion in 2025 MADISON, Wis. / Oct 04, 2024 / Business Wire /...Read more
Approval is based on the CheckMate-77T trial, in which the Opdivo-based regimen demonstrated significantly longer event-free survival compared to the chemotherapy and placebo arm; a high pathologic complete response rate was also observed1 Opdivo is the only approved PD-1 inhibitor for resectable NSCLC in both a neoadjuvant-only regimen and as part of a perioperative treatment regimen1 This milestone adds to Bristol Myers Squibb’s...Read more
GE HealthCare’s FDA-approved flurpiridaz F 18 PET radiotracer, Flyrcado, delivers higher diagnostic efficacy in patients with known or suspected coronary artery disease (CAD), compared to SPECT MPI, the predominant procedure used in nuclear cardiology today With a half-life over ten times longer than currently approved cardiac PET radiotracers, Flyrcado brings the first practical opportunity to combine exercise stress testing with...Read more
Dupixent is indicated for the approximately 300,000 adults in the U.S. with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype Following recent approvals in the EU and China, the U.S. approval is based on two landmark Phase 3 trials that showed Dupixent achieved significant reduction in exacerbations, and also showed improvements in lung function and...Read more
Milestone triggers payments to PureTech totaling $29 million under agreements with Royalty Pharma and PureTech’s Founded Entity, Karuna Therapeutics, which was acquired by Bristol Myers Squibb in March 2024, and unlocks potential future payments related to additional milestones and royalties Bristol Myers Squibb to market KarXT as CobenfyTM1 Cobenfy is the first new drug mechanism approved in over 50 years for the treatment of...Read more
COBENFY represents the first new pharmacological approach to treat schizophrenia in decades, with a mechanism of action distinct from current therapies Approval is supported by data from the EMERGENT clinical program demonstrating statistically significant reductions of schizophrenia symptoms The safety and tolerability profile of COBENFY has been established across acute and long-term trials in schizophrenia PRINCETON, N.J. / Sep...Read more
NEW YORK / Sep 26, 2024 / Business Wire / Establishment Labs Holdings Inc. (NASDAQ: ESTA), a global medical technology company dedicated to improving women’s health and wellness, principally in breast aesthetics and reconstruction, announced it has received approval from the U.S. Food and Drug Administration (FDA) for the use of Motiva® SmoothSilk® Ergonomix® and Motiva® SmoothSilk® Round breast implants in primary and revision breast...Read more
Based on LAURA Phase III trial results which showed TAGRISSO extended median progression-free survival by more than three years WILMINGTON, Del. / Sep 26, 2024 / Business Wire / AstraZeneca’s TAGRISSO® (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or...Read more
PRINCETON, N.J., Sept. 26, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Ketoconazole Shampoo, 2%. ANI’s Ketoconazole Shampoo, 2% is the generic version of the reference listed drug (RLD) Nizoral®. "We are proud to announce the FDA...Read more
MIPLYFFA™ is the first therapy approved for use in patients with NPC, a rare genetic disorder XOMA Royalty is entitled to receive a mid-single digit royalty on MIPLYFFA™ sales and up to $52.6 million in milestones MIPLYFFA™ is now the sixth commercial asset in XOMA Royalty’s portfolio EMERYVILLE, Calif., Sept. 23, 2024 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA), the biotech royalty aggregator, announced today Zevra...Read more
MIPLYFFA is the first FDA-approved treatment for Niemann-Pick disease type C (NPC), an ultra-rare and progressive neurodegenerative disease MIPLYFFA is indicated for use in combination with miglustat for the treatment of neurological manifestations of NPC in adults and pediatric patients 2 years of age and older Zevra receives rare pediatric disease priority review voucher in conjunction with approval Company launches AmplifyAssist™...Read more
Only influenza vaccine approved for self- or caregiver-administration at home, expanding options for influenza protection WILMINGTON, Del. / Sep 20, 2024 / Business Wire / FLUMIST® has been approved in the US as the only self-administered influenza vaccine. FLUMIST, a needle-free nasal spray, was approved to be self-administered by adults up to 49 years of age or administered by a parent/caregiver to individuals 2-17 years of age.1 The...Read more
Approval based on compelling safety and efficacy from the Phase 3 MARIPOSA-2 study, marking the third new indication for RYBREVANT® this year, with four indications overall RARITAN, N.J., Sept. 17, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) approved RYBREVANT® (amivantamab-vmjw) in combination with standard of care chemotherapy (carboplatin and pemetrexed)...Read more
U.S. Food and Drug Administration approves Zenrelia, a once-daily oral JAK inhibitor for dogs with allergic and atopic dermatitis Elanco enters the estimated $1.7 billion global canine dermatology market, highly accretive to existing portfolio In a head-to-head study, Zenrelia was shown to be at least as effective as the market incumbent JAK inhibitor at the primary end point, with an additional endpoint at which Zenrelia got 77% of...Read more
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids WILMINGTON, Del. / Sep 18, 2024 / Business Wire / AstraZeneca’s FASENRA® (benralizumab) has been approved in the US for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).1 EGPA is a rare, immune-mediated vasculitis that can result in...Read more
Approval based on results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival versus chemotherapy alone Approval marks the first indication for KEYTRUDA in MPM in the U.S. RAHWAY, N.J. / Sep 18, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug...Read more
Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2 Kisqali® (ribociclib) significantly reduced the risk of recurrence by 25% vs. endocrine therapy (ET) alone; consistent benefit and a well-tolerated safety profile seen across all subgroups in pivotal Phase III NATALEE trial, including patients with...Read more
MARLBOROUGH, Mass., Sept. 17, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration (FDA) approval to expand the indication for current-generation INGEVITY™+ Pacing Leads – thin wires placed inside the heart and connected to an implantable device – to include conduction system pacing (CSP) and sensing of the left bundle branch area (LBBA) when connected to a single- or dual-chamber...Read more
Eversense 365 cleared in the U.S. as an integrated continuous glucose monitoring (iCGM) system for people with diabetes With a single sensor, the Eversense 365 system provides one year of use, versus 10-14 days with short-term CGM’s for minimal life disruption Launch expected early in the fourth quarter of 2024 GERMANTOWN, Md. and PARSIPPANY, N.J., Sept. 17, 2024 (GLOBE NEWSWIRE) -- Senseonics Holdings, Inc. (NYSE American:...Read more
EBGLYSS provides a new first-line biologic treatment for moderate-to-severe atopic dermatitis that is not well controlled with topicals Patients treated with EBGLYSS experienced significant skin clearance as early as four weeks and meaningful itch relief as early as two weeks EBGLYSS delivers long-lasting efficacy for patients through one year of treatment with a monthly maintenance dose INDIANAPOLIS, Sept. 13, 2024 /PRNewswire/ --...Read more
Ocrevus Zunovo™ has the potential to expand treatment options to centers without IV infrastructure or with IV constraints, like at a doctor's office This approval is backed by a decade of proven safety and efficacy data of Ocrevus® IV, with over 350,000 people treated globally Ocrevus Zunovo™ offers people with multiple sclerosis (MS) more options to access treatment based on their individual needs SOUTH SAN FRANCISCO, Calif. / Sep...Read more
Following Priority Review, Dupixent is now available to patients as young as 12 years with inadequately controlled CRSwNP Current treatment options leave many patients with uncontrolled disease and often result in the recurrence of nasal polyps Dupixent is the leading biologic medicine for all five FDA-approved indications in new-to-brand prescriptions TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron...Read more
Tecentriq Hybreza provides patients and physicians with greater flexibility of treatment options while showing safety and efficacy consistent with intravenous (IV) Tecentriq New subcutaneous (SC) option reduces treatment time to approximately 7 minutes, compared with 30-60 minutes for IV infusion SOUTH SAN FRANCISCO, Calif. / Sep 12, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced...Read more
The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal QUASAR program1,2,3,4,5 TREMFYA® is now approved for the treatment of plaque psoriasis, active psoriatic arthritis and ulcerative colitis HORSHAM, Pa., Sept. 11, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ)...Read more
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years Conversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation compared to the active comparator...Read more
Represents Amneal’s fourth 505(b)(2) injectable approval in 2024 Ready-to-use oncology treatment used for multiple myeloma and mantle cell lymphoma BRIDGEWATER, N.J. / Sep 05, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) and Shilpa Medicare Limited (“Shilpa”) announced U.S. Food and Drug Administration (FDA) approval of BORUZU™, a new presentation of bortezomib for ready-to-use...Read more
TruSight Oncology Comprehensive is the first US FDA-approved, distributable comprehensive genomic profiling IVD kit with pan-cancer companion diagnostic claims The 500+ gene biomarker test advances access to localized precision oncology for patients SAN DIEGO, Aug. 27, 2024 /PRNewswire/ -- Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, today announced Food and Drug Administration...Read more
The updated COVID-19 vaccine is tailored to the KP.2 strain of the SARS-CoV-2 Omicron JN.1 lineage and is recommended for individuals 6 months of age and older The KP.2 adaptation is based on FDA guidance, which stated that KP.2 is the preferred strain for COVID-19 vaccines for the US 2024-2025 fall and winter season, if feasible Shipping will begin immediately to ensure robust supply and rapid access of this season’s vaccine in...Read more
Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval CAMBRIDGE, MA / ACCESSWIRE / AUGUST 22, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Spikevax® (2024-2025 formula) for individuals 12 years and above. Emergency Use...Read more
Propofol is an essential surgical anesthetic in hospitals that is in chronic shortage Complex emulsion injectable expands Amneal’s injectables portfolio BRIDGEWATER, N.J. / Aug 20, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (FDA) for Propofol Injectable...Read more
RYBREVANT® plus LAZCLUZE™ is the first and only chemotherapy-free regimen showing superior progression-free survival versus osimertinib Following Priority Review, approval is based on Phase 3 MARIPOSA results showing RYBREVANT® plus LAZCLUZE™ reduced the risk of disease progression or death by 30 percent versus osimertinib, with a nine-month-longer median duration of response RARITAN, N.J., Aug. 20, 2024 /PRNewswire/ -- Johnson...Read more
FDA confirmed that the amendment to add PH-ILD to the YUTREPIA NDA was proper and that application otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act Final Approval of YUTREPIA for PAH and PH-ILD may occur after expiration of 3-year regulatory exclusivity for Tyvaso DPI on May 23, 2025 FDA’s tentative approval is based upon all information submitted in the NDA, including the status of good...Read more
Based on AEGEAN Phase III trial results which showed IMFINZI-based regimen reduced the risk of recurrence, progression or death by 32% vs. neoadjuvant chemotherapy alone WILMINGTON, Del. / Aug 16, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage (IIA-IIIB) non-small cell lung cancer (NSCLC) and no known...Read more
YAVNE, Israel, Aug. 15, 2024 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD), the global leader in next-generation enzymatic therapeutics for tissue repair, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) allowing for eschar removal in pediatric patients aged newborn through eighteen with deep partial- and/or full-thickness thermal burns. With this FDA...Read more
Approval Expands NexoBrid Target Customer Base to Include Approximately 20 Pediatric Burn Centers CAMBRIDGE, Mass., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that the U.S. Food and Drug Administration (FDA) has approved a pediatric indication for NexoBrid® (anacaulase-bcdb) for eschar removal in pediatric...Read more
Niktimvo™ (axatilimab-csfr) is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD Pivotal data from the AGAVE-201 study supporting the approval show treatment with Niktimvo resulted in durable responses across all organs studied and patient subgroups Syndax conference call and webcast scheduled for today at 6:00 p.m. ET WILMINGTON, Del. & WALTHAM, Mass. / Aug 14, 2024 /...Read more
First and Only Treatment to Demonstrate Statistically Significant Reductions Across Key Biomarkers, ALP Normalization and Pruritus Versus Placebo Livdelzi Expands Gilead’s Long-Standing Commitment to People Living with Liver Disease FOSTER CITY, Calif. / Aug 14, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi®...Read more
Hypoparathyroidism is a rare endocrine disease with multi-organ impacts affecting an estimated 70,000 to 90,000 people in the United States Ascendis to host investor conference call Monday, August 12, at 8:00 a.m. E.T. COPENHAGEN, Denmark, Aug. 12, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the U.S. Food & Drug Administration (FDA) has approved YORVIPATH® (palopegteriparatide; developed...Read more
FUROSCIX is now indicated for the treatment of congestion due to fluid overload in adult patients with chronic heart failure, regardless of New York Heart Association (NYHA) functional class Indication expansion allows for the use of FUROSCIX in NYHA Class IV chronic heart failure patients BURLINGTON, Mass., Aug. 12, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on...Read more
neffy Offers Adults and Children (≥30 kg) Living with Severe Allergic Reactions the First New Delivery Method for Epinephrine in more than 35 Years Well-capitalized to Support Launch and Commercialization of neffy in the U.S., and an Expected Operating Runway of at Least Three Years ARS Pharma to Host Investor Conference Call on Monday, August 12, 2024, at 8:00 am ET SAN DIEGO, Aug. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals,...Read more
Only systemic treatment for relapsed or refractory (r/r) CTCL to target the IL-2 receptor on malignant T-cells and Tregs LYMPHIR is expected to launch within the next five months LYMPHIR's approval marks the first novel targeted systemic therapy approved by the FDA r/r CTCL since 2018 Approval based on Phase 3 Pivotal Study 302 results that demonstrated 36% ORR, reduction in skin disease in 84% of patients, clinically significant...Read more
Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs. placebo (p<0.0001)1 Fabhalta is an inhibitor of the alternative complement pathway, activation of which is thought to contribute to the pathogenesis of IgAN1-4 Despite current standard of care, up to 50% of IgAN patients with persistent...Read more
Delivers more “Good On” time with less frequent dosing compared to Immediate Release CD/LD Underscores Amneal’s leadership in Parkinson’s disease and commitment to one million people currently living with Parkinson’s disease in the U.S. CREXONT commercial launch planned in September 2024 BRIDGEWATER, N.J. / Aug 07, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the...Read more
Medtronic Diabetes expands CGM offerings to meet more people where they are in their diabetes journey DUBLIN, Aug. 7, 2024 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval for its Simplera™ continuous glucose monitor (CGM) — the company's first disposable, all-in-one CGM that's half the size of previous Medtronic CGMs. The discreet...Read more
MALVERN, Pa., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies and vaccines, today announced that it has received notification from FDA to begin its expanded access program (EAP) for the treatment of adult patients, aged 18 and older, with retinitis pigmentosa (RP) with OCU400—a modifier...Read more
Approved for advanced MAGE-A4+synovial sarcoma in adults with certain HLA types who have received prior chemotherapy TECELRA is the first new treatment option for people with synovial sarcoma in more than a decade Adaptimmune to hold webcast at https://www.gowebcasting.com/13428 on August 2, at 8:00 a.m. EDT PHILADELPHIA & OXFORD, England / Aug 01, 2024 / Business Wire / Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company...Read more
Jemperli approval now includes MMRp/MSS tumors, which represent majority of endometrial cancer cases Jemperli plus chemotherapy demonstrated a statistically significant and clinically meaningful 31% reduction in risk of death versus chemotherapy alone PHILADELPHIA / Aug 01, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) in combination...Read more
Findings from first-ever quadruplet therapy study with subcutaneous DARZALEX FASPRO® showed 60 percent reduction in risk of disease progression or death New regimen solidifies DARZALEX FASPRO® as a foundational frontline therapy in multiple myeloma with potential to significantly delay disease progression HORSHAM, Pa., July 30, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today that the U.S. Food and...Read more
The Second Oral Therapy Approved This Decade, ZUNVEYL’s Dual MOA Was Designed to Eliminate Drug Absorption in the Gastrointestinal (GI) Tract, Potentially Addressing Certain Tolerability Issues with Leading Alzheimer’s Disease (AD) Medications, Combined with a Long-Term Efficacy Profile ZUNVEYL’s Innovative Approach Targets AD Symptoms Directly, Designed to Provide Patients with Significant Benefits to Cognitive and Global Function and...Read more
Shield is first blood test approved by FDA as a primary screening option for colorectal cancer and that meets performance requirements for Medicare coverage Blood test offers easy, convenient and pleasant screening option with potential for improving colorectal cancer screening rates Guardant Health to host investor conference call and webcast Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT PALO ALTO, Calif. / Jul 29, 2024 / Business...Read more
FOSTER CITY, Calif. / Jul 25, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion for LIVMARLI® (maralixibat) oral solution for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). The expanded label includes use in PFIC patients 12 months and older as well as the higher...Read more
VOQUEZNA is now approved and available to treat the largest category of Gastroesophageal Reflux Disease (GERD) VOQUEZNA met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid reduction of heartburn with daily treatment VOQUEZNA represents the first major innovation in GERD treatment in over 30 years and the only FDA-approved treatment of its kind available in the U.S. FLORHAM PARK, N.J., July...Read more
PRINCETON, N.J., July 15, 2024 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched L-Glutamine Oral Powder. ANI’s L-Glutamine Oral Powder is the generic version of the reference listed drug (RLD) Endari®. "The approval and launch of L-Glutamine...Read more
ZORYVE cream provides rapid relief, with efficacy, safety, and tolerability demonstrated up to 56 weeks of treatment ZORYVE cream rapidly and significantly reduces itch, the most bothersome symptom of atopic dermatitis (AD) Once-daily cream is for use anywhere on the body for any duration AD is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States Third FDA approval...Read more
Vabysmo PFS is the first and only syringe prefilled with an FDA-approved bispecific antibody to treat retinal conditions that can cause blindness Designed to simplify administration, Vabysmo PFS provides retina specialists a ready-to-use option Vabysmo PFS will be available for people living with wet AMD, DME and RVO SOUTH SAN FRANCISCO, Calif. / Jul 05, 2024 / Business Wire / Genentech, a member of the Roche Group (SIX: RO, ROG;...Read more
Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39% Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment...Read more
Approval based on results from Phase 1/2 EPCORE® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL EPKINLY offers an off-the-shelf, T-cell engaging treatment option that enables treatment across practice settings to address high clinical need EPKINLY is the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R)...Read more
EPKINLY is now the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL) Bispecific antibodies are designed to induce targeted cell killing by engaging the immune system FL is considered incurable with current standard of care therapies. Many people living with FL who have relapsed or are refractory to existing...Read more
Ohtuvayre is indicated for the maintenance treatment of COPD allowing for broad use in COPD patients First inhaled COPD treatment providing bronchodilation and non-steroidal anti-inflammatory effects Conference call tomorrow at 8:30 a.m. EDT / 1:30 p.m. BST LONDON and RALEIGH, N.C., June 26, 2024 (GLOBE NEWSWIRE) -- Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration...Read more
PLYMOUTH MEETING, Pa., June 24, 2024 /PRNewswire/ -- Harmony Biosciences (Nasdaq: HRMY) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for WAKIX® (pitolisant) tablets for the treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy. The FDA separated the submission into two sNDAs for administrative purposes to...Read more
VYVGART® Hytrulo is first and only neonatal Fc receptor (FcRn) blocker approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP) First novel, precision mechanism of action in more than 30 years for patients with CIDP Third approved indication for VYVGART® and VYVGART Hytrulo franchise Management to host conference call on June 21, 2024 at 11:00pm CET (5:00pm ET) Amsterdam, the Netherlands – argenx SE (Euronext...Read more
FDA grants traditional approval to ELEVIDYS for ambulatory Duchenne patients FDA grants accelerated approval to ELEVIDYS for non-ambulatory Duchenne patients Sarepta will host an investor conference call on June 21, 2024, at 8:30 a.m. ET CAMBRIDGE, Mass. / Jun 20, 2024 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced U.S. Food and Drug...Read more
Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI® for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND2 Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint1,2 SKYRIZI is the first IL-23...Read more
CAPVAXIVE (V116) is specifically designed for adults and covers serotypes responsible for approximately 84% of invasive pneumococcal disease in adults 50 years of age and older Across four Phase 3 studies, CAPVAXIVE demonstrated robust immune responses in both vaccine-naïve and vaccine-experienced adult populations RAHWAY, N.J. / Jun 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada,...Read more
ClearPoint Neuro is a global therapy-enabling platform company providing stereotactic navigation and delivery to the brain. Applications of our ClearPoint Neuro Navigation System include electrode lead placement, placement of catheters, and biopsy. The platform has FDA clearance and is...
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