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
KEYTRUDA is now the first and only anti-PD-1 therapy FDA-approved in combination with chemotherapy for adult patients with primary advanced or recurrent endometrial carcinoma regardless of mismatch repair status Approval marks the third FDA-approved indication for KEYTRUDA in endometrial carcinoma and the 40th indication for KEYTRUDA in the US RAHWAY, N.J. / Jun 17, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the...Read more
EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) -- Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”),...Read more
Approval based on DUO-E trial results, which showed IMFINZI reduced the risk of disease progression or death by 58% vs. chemotherapy WILMINGTON, Del. / Jun 17, 2024 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with carboplatin and paclitaxel followed by IMFINZI monotherapy has been approved in the US as treatment for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair...Read more
With Biotest-developed Yimmugo, Grifols adds to its remarkable franchise of intravenous and subcutaneous immunoglobulins to meet strong demand Yimmugo, already approved for production and marketing in Europe, is the first U.S.-approved medicine in Biotest’s portfolio and is manufactured with an innovative process at Biotest’s new FDA-certified ‘Next Level’ facility U.S. approval of Yimmugo paves the way for other Biotest proteins in...Read more
BLINCYTO® Added to Multiphase Consolidation Chemotherapy Reduced Risk of Death by 58% Showing Superior Overall Survival Versus Chemotherapy Alone First and Only Bispecific T-cell Engager (BiTE®) Therapy for Consolidation Treatment Regardless of Measurable Residual Disease (MRD) Status THOUSAND OAKS, Calif., June 14, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has...Read more
Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors, demonstrating clinically meaningful response rates in the TRIDENT-1 trial1 This accelerated approval marks the second indication for Augtyro in the U.S.1 PRINCETON, N.J. / Jun 13, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more
US patients aged 10 years and older can now benefit from FARXIGA for type-2 diabetes Approval based on results from T2NOW, one of the largest pediatric type-2 diabetes Phase III trials to date WILMINGTON, Del. / Jun 12, 2024 / Business Wire / AstraZeneca’s FARXIGA® (dapagliflozin) has been approved by the US Food and Drug Administration (FDA) to improve glycemic control in pediatric patients with type-2 diabetes (T2D) aged 10 years...Read more
Approval in patients with pJIA weighing 63kg or greater adds to Kevzara’s position in treating adult chronic inflammatory conditions of moderately to severely active rheumatoid arthritis and polymyalgia rheumatica TARRYTOWN, N.Y. and CAMBRIDGE, MA, June 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration has approved Kevzara® (sarilumab) for...Read more
Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes1 Clinical development program continues to evaluate safety and immunogenicity in adults 18+ with data read-outs expected H2 2024 PHILADELPHIA / Jun 07, 2024 / Business Wire / GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved AREXVY (Respiratory Syncytial Virus (RSV)...Read more
Approval across ESA ineligible and ESA relapsed/refractory patients with LR-MDS with transfusion-dependent anemia, regardless of ring sideroblast (RS) status Durable and sustained red blood cell transfusion independence, increases in hemoglobin levels and reduction in transfusion burden observed across key LR-MDS subgroups in the IMerge Phase 3 clinical trial; the most common Grade 3/4 adverse reactions were thrombocytopenia and...Read more
mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes CAMBRIDGE, MA / ACCESSWIRE / May 31, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV...Read more
CORAL GABLES, Fla., May 30, 2024 (GLOBE NEWSWIRE) -- Catalyst Pharmaceuticals, Inc. ("Catalyst" or "Company") (Nasdaq: CPRX), a commercial-stage biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has approved its supplemental New Drug Application (“sNDA”)...Read more
In the MCL cohort of TRANSCEND NHL 001, Breyanzi delivered responses in 85.3% of patients with a one-time infusion while demonstrating a consistent safety profile across clinical trials Breyanzi is the only CAR T cell therapy approved by the FDA for four distinct subtypes of non-Hodgkin lymphoma, bringing this personalized therapy to the broadest array of patients with B-cell malignancies PRINCETON, N.J. / May 30, 2024 / Business Wire...Read more
VALENCIA, Calif., May 30, 2024 (GLOBE NEWSWIRE) -- AVITA Medical, Inc. (NASDAQ: RCEL, ASX: AVH), a commercial-stage regenerative medicine company focused on first-in-class devices for wound care management and skin restoration, today announced that the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) supplement for the RECELL GO™ System, its next-generation autologous cell harvesting device that harnesses...Read more
U.S. FDA approves new one pill, once-daily AUSTEDO XR tablets (30, 36, 42, 48 mg/day) AUSTEDO XR offers more flexibility with the most once-daily doses of any vesicular monoamine transporter 2 (VMAT2) inhibitor for effective and tolerable tardive dyskinesia (TD) and Huntington’s disease (HD) chorea control1 Patients with TD taking AUSTEDO XR can expect symptom improvement as early as two weeks while patients with HD chorea may...Read more
Breakthrough DLL3-Targeting Therapy Regimen for a Major Solid Tumor IMDELLTRA Demonstrated Impressive 40% Objective Response Rate, 9.7 Month Median Duration of Response and 14.3 Month Median Overall Survival in Pivotal DeLLphi-301 Study Amgen to Host Webcast Investor Call on May 20, 2024 at 1:00 p.m. PT THOUSAND OAKS, Calif., May 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug...Read more
95.7% of patients responded to Breyanzi in the TRANSCEND FL trial Breyanzi provided sustained clinical benefit with median duration of response not reached and the majority (77.1%) of responders in ongoing response at 18 months Breyanzi is a personalized therapy with a differentiated profile, offering durable responses and a consistent safety profile across trials PRINCETON, N.J. / May 15, 2024 / Business Wire / Bristol Myers Squibb...Read more
More than half of all U.S. cervical cancer patients are underscreened1, which makes reducing barriers to sample collection and increasing access to screenings crucial to ultimately helping eliminate this deadly disease. Each year in the U.S., more than 13,000 patients are diagnosed with cervical cancer and approximately 4,000 die from this preventable disease, caused by HPV infection.1 Roche’s human papillomavirus (HPV) self-collection...Read more
Clinolipid provides calories and essential fatty acids for parenteral nutrition Expanded indication demonstrates Baxter’s continued commitment to meeting the diverse nutritional needs of patients, from preterm neonates to adults DEERFIELD, Ill. / May 13, 2024 / Business Wire / Baxter International Inc. (NYSE:BAX), a global leader in nutrition therapy, today announced U.S. FDA approval of an expanded indication for Clinolipid (Lipid...Read more
Diarrhea is one of the most common reasons for veterinary visits for dogs and the second most common reason for visits to the veterinary emergency room, yet there are currently no FDA-approved anti-secretory agents to treat canine diarrhea SAN FRANCISCO, CA / ACCESSWIRE / May 6, 2024 / Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar") today announced that it has established a new Investigational New Animal Drug (INAD) file with the Center...Read more
SAN DIEGO, April 30, 2024 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced the U.S. Food and Drug Administration has approved INGREZZA® SPRINKLE (valbenazine) capsules, a new oral granules formulation of INGREZZA® (valbenazine) capsules prescribed for the treatment of adults with tardive dyskinesia and chorea associated with Huntington's disease.1 INGREZZA SPRINKLE provides an alternative administration...Read more
TIVDAK is the first antibody-drug conjugate (ADC) to have positive overall survival data for patients with previously treated recurrent or metastatic cervical cancer Conversion to full approval from accelerated approval is based on positive results from global Phase 3 study demonstrating overall survival benefit of TIVDAK compared to chemotherapy NEW YORK & COPENHAGEN, Denmark / Apr 29, 2024 / Business Wire / Pfizer Inc. (NYSE:...Read more
More than 20 million people in the U.S. are living with peripheral artery disease (PAD) yet there have been limited treatment options The first-of-its-kind Esprit™ BTK Everolimus Eluting Resorbable Scaffold dissolves over time after it has opened blocked arteries below the knee (BTK) The Esprit BTK System is a dissolving stent that offers the possibility of better outcomes for people with the most severe form of PAD ABBOTT PARK,...Read more
Assay expands company's leadership in precision medicine and cell and gene therapy BURLINGTON, N.C., April 29, 2024 /PRNewswire/ -- Labcorp (NYSE: LH), a global leader of innovative and comprehensive laboratory services, today announced the U.S. Food and Drug Administration (FDA) has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with...Read more
Libervant is the first and only FDA approved orally administered rescue product for the treatment of seizure clusters in patients ages 2 to 5 Announces immediate availability of Libervant 5mg, 7.5mg, 10mg, 12.5mg, and 15mg for patients between 2 to 5 years of age Company track record now includes 4 FDA approvals since 2018 Anaphylm program on track; NDA submission expected by the end of 2024 Hosts conference call for investors on...Read more
XOLREMDI targets CXCR4 pathway dysfunction, the underlying cause of WHIM syndrome Breakthrough Therapy approval follows Priority Review of 4WHIM Phase 3 clinical trial data X4 granted Rare Pediatric Disease Priority Review Voucher (PRV) concurrent with approval Conference call and webcast to be hosted today at 8:30 am ET BOSTON, April 29, 2024 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the...Read more
A one-time dose of BEQVEZ has reduced bleeds post-treatment compared to standard of care with a median of zero bleeds (range 0 to 19) after up to three years of follow-up, providing sustained bleed protection and potentially avoiding years of treatment burden with prophylaxis for many patients NEW YORK / Apr 26, 2024 / Business Wire / Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved...Read more
Additional Data in Pregnant Adults Who Are Virologically Suppressed Reinforce Safety and Tolerability Profile of Biktarvy in Broad Range of People With HIV Perinatal Guidelines Recognize Biktarvy as Alternative Regimen for Use During Pregnancy and for Those Trying to Conceive FOSTER CITY, Calif. / Apr 26, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) approved an...Read more
Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain DUBLIN, April 26, 2024 /CNW/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to...Read more
CTX-009, the Company’s bispecific DLL4/VEGF-A antibody, in combination with paclitaxel, has shown promising clinical responses in patients with advanced biliary tract cancer (BTC) in its Phase 2 study Top-line data readout for COMPANION-002, the Company’s randomized Phase 2/3 BTC U.S. study, is expected by the end of 2024 BOSTON, April 25, 2024 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage,...Read more
Company launches generic equivalent to OTC NARCAN® Nasal Spray Provides convenient, affordable access to life-saving medicine BRIDGEWATER, N.J. / Apr 24, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced the availability of Over the Counter (“OTC”) Naloxone Hydrochloride (Naloxone HCI) Nasal Spray, USP, 4mg, following Abbreviated New Drug Application (“ANDA”) approval from...Read more
First and only FDA-approved type II RAF inhibitor for patients with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation RAPNO LGG overall response rate (ORR) of 51% Day One receives rare pediatric disease priority review voucher Conference call and webcast to be April 24, 8:30 a.m. Eastern Time BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq:...Read more
Designated an FDA Breakthrough Therapy, the novel immunotherapy ANKTIVA activates the body’s natural killer (NK) and killer T-cell immune system to attack tumor cells Therapy stimulates memory T cells, leading to long duration of complete response exceeding 47 months and ongoing to date, with a median duration of response yet to be determined The percentage of patients with durable responses at 12 and 24 months exceeded the benchmark...Read more
ENTYVIO is Now Available in the U.S. in Both IV and Subcutaneous Administrations for Maintenance Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease OSAKA, Japan & CAMBRIDGE, Mass. / Apr 18, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance...Read more
Approval based on Phase III ALINA study showing Alecensa reduced the risk of disease recurrence or death by an unprecedented 76% in people with ALK-positive early-stage resected non-small cell lung cancer (NSCLC) This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy The National Comprehensive...Read more
SELARSDI is approved for both adult and pediatric indications and is the second biosimilar approved under the strategic partnership between Alvotech and Teva SELARSDI is expected to be marketed in the U.S. on or after February 21, 2025, following a settlement agreement with Johnson & Johnson, the manufacturer of Stelara SELARSDI was developed and is manufactured by Alvotech using murine cell (Sp2/0) and a continuous perfusion...Read more
Additional indication for pediatric patients with severe eosinophilic asthma WILMINGTON, Del. / Apr 11, 2024 / Business Wire / AstraZeneca’s FASENRA® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype.1 FASENRA was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic...Read more
New indication for this one-time infusion may provide patients with a treatment-free respite as early as first relapse SOMERSET, N.J. / Apr 05, 2024 / Business Wire / Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of patients with relapsed or refractory...Read more
Expanded indication for this one-time infusion will provide more patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with CARVYKTI® in 1-3 prior lines of therapy reduced the risk of disease progression or death by 59 percent compared to standard therapies HORSHAM, Pa., April 5, 2024 /PRNewswire/...Read more
Based on three Phase II trials of AstraZeneca and Daiichi Sankyo’s ENHERTU which showed clinically meaningful responses across a broad range of tumors ENHERTU now has five approved indications with the latest in HER2-expressing (IHC 3+) metastatic cancers WILMINGTON, Del. / Apr 05, 2024 / Business Wire / AstraZeneca and Daiichi Sankyo's ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult...Read more
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile Expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering meaningful treatment-free intervals when...Read more
Fanapt® Treatment is Now Available to Adult Patients for the Acute Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder Approval Represents Significant Novel Indication for Vanda's Fanapt® Franchise WASHINGTON, April 2, 2024 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute...Read more
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery More than 1.6 million people in the U.S. are affected by tricuspid regurgitation,1 which can severely impact quality of life Data from the TRILUMINATE™ Pivotal trial demonstrated that patients who received TriClip experienced a marked improvement in the severity of their symptoms...Read more
Approval of first-in-class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase III trial WILMINGTON, Del. / Apr 01, 2024 / Business Wire / VOYDEYA™ (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobinuria (PNH).1 VOYDEYA is a first-in-class, oral, Factor D inhibitor developed as an add-on...Read more
Efficacy and Safety Profile of Once-Daily Vemlidy Demonstrated in Children Six Years of Age (Weighing at Least 25kg) and Older FOSTER CITY, Calif. / Mar 28, 2024 / Business Wire / Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy® (tenofovir alafenamide) 25 mg tablets as a once-daily treatment for chronic...Read more
Once-Daily Oral HIF-PH Inhibitor Activates Physiologic Response to Manage Anemia Akebia's Launch Strategy Developed to Drive Toward a Potential New Oral Standard of Care Company to Host Conference Call on Thursday, March 28 at 8:00 AM ET CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney...Read more
The Evolut™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access DUBLIN, March 27, 2024 /CNW/ -- Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that the United States Food and Drug Administration (FDA) has approved the Evolut™ FX+ transcatheter aortic valve replacement (TAVR) system for the treatment of symptomatic severe...Read more
WINREVAIR is a breakthrough biologic for this rare, progressive disease WINREVAIR on top of background therapy significantly improved exercise capacity and multiple important secondary outcome measures compared to background therapy alone RAHWAY, N.J. / Mar 26, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved...Read more
The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria Malaria is a serious and potentially fatal parasitic infection most commonly transmitted by mosquitoes that can also be spread through blood transfusion Roche is dedicated to saving patients’ lives through diagnostic solutions that aid in the protection of the global blood supply from infectious diseases Basel, 26 March 2024 -...Read more
Product references branded Ciprodex Represents another complex, high value new product BRIDGEWATER, N.J. / Mar 25, 2024 / Business Wire / Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) (“Amneal” or the “Company”) today announced it has received Abbreviated New Drug Application (“ANDA”) approval from the U.S. Food and Drug Administration (“FDA”) for ciprofloxacin and dexamethasone otic suspension. This product is a combination of...Read more
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+ NMOSD the potential to live relapse-free Unprecedented relapse risk reduction observed in CHAMPION-NMOSD trial underscores how ULTOMIRIS may redefine patient journey for rare neurological disease WILMINGTON, Del. / Mar 25, 2024 / Business Wire / ULTOMIRIS® (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5...Read more
New Labels Expand Treatable Population to ~70 Million Patients in U.S. First LDL-C Lowering Non-Statin Indicated for Primary Prevention Patients Approvals Based on Positive CLEAR Outcomes Data and Reflect a Highly Differentiated Product Profile Positive CHMP Opinion Received; European Cardiovascular (CV) Risk Reduction Label Determination Anticipated in Q2 2024 Conference Call and Webcast on Monday, March 25 at 8:00 a.m. ET ANN...Read more
New Labels Expand Treatable Population to ~70 Million Patients in U.S. First LDL-C Lowering Non-Statin Indicated for Primary Prevention Patients Approvals Based on Positive CLEAR Outcomes Data and Reflect a Highly Differentiated Product Profile Positive CHMP Opinion Received; European Cardiovascular (CV) Risk Reduction Label Determination Anticipated in Q2 2024 Conference Call and Webcast on Monday, March 25 at 8:00 a.m. ET ANN...Read more
The full approval of ELAHERE is based on the confirmatory MIRASOL Phase 3 trial that supports the medicine as a potential new standard of care for folate receptor alpha (FRα)-positive, platinum-resistant ovarian cancer (PROC) Data show that ELAHERE treatment resulted in an overall survival benefit and reduced the risk of cancer progression by 35% ELAHERE represents AbbVie's first approved solid tumor treatment following the recent...Read more
ReOpen was the first ever large placebo-controlled clinical trial program to demonstrate statistically significant reduction of symptoms in chronic sinusitis patients without nasal polyps Clinical trial program also showed reduction in sinus inflammation and in acute exacerbations, which frequently result in use of antibiotics XHANCE uses the proprietary Exhalation Delivery System to enable deposition of a proven steroid in target...Read more
Breyanzi offers a personalized treatment option delivered as a one-time infusion that provides deep and durable responses for patients with relapsed or refractory CLL or SLL who have historically had no standard of care In TRANSCEND CLL 004, the first pivotal multicenter trial to evaluate a CAR T cell therapy in patients with relapsed or refractory CLL or SLL, 20% of patients treated with Breyanzi achieved a complete response (CR) with...Read more
Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”) Accelerated approval was based on Phase 3 data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis Madrigal conference call...Read more
FDA approval based on MARCH Phase 3 study with highly statistically significant (p<0.0001) reduction in pruritus severity between LIVMARLI vs. placebo Label covers broad range of PFIC subtypes Immediate launch and availability for eligible patients in the U.S. FOSTER CITY, Calif. / Mar 13, 2024 / Business Wire / Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that the U.S. Food and Drug Administration (FDA) has approved...Read more
TARRYTOWN, N.Y., March 11, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced the U.S. Food & Drug Administration (FDA) has extended the approval of Praluent® (alirocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies to include pediatric patients aged 8 and older with heterozygous familial hypercholesterolemia (HeFH). “Many children with heterozygous...Read more
Bagsværd, Denmark, 8 March 2024 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and...Read more
BRUKINSA is the first and only BTK inhibitor approved across five oncology indications and the first and only approved in follicular lymphoma Approval based on positive results from ROSEWOOD trial showing BRUKINSA plus obinutuzumab achieved higher overall response rate versus obinutuzumab alone BASEL, Switzerland & BEIJING & CAMBRIDGE, Mass. / Mar 07, 2024 / Business Wire / BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE:...Read more
THE FIRST AND ONLY HYALURONIC ACID DERMAL FILLER APPROVED FOR THE IMPROVEMENT OF MODERATE TO SEVERE TEMPLE HOLLOWING1 IRVINE, Calif., March 5, 2024 /PRNewswire/ -- Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of JUVÉDERM® VOLUMA® XC for injection in the temple region to improve moderate to severe temple hollowing in adults over the age of 21.1 JUVÉDERM® VOLUMA® XC is the first and...Read more
BEDFORD, Mass., March 04, 2024 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“Lantheus”) (NASDAQ: LNTH), the leading radiopharmaceutical-focused company committed to enabling clinicians to Find, Fight and Follow® disease to deliver better patient outcomes, today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for DEFINITY® (Perflutren Lipid Microsphere) as an ultrasound...Read more
Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations National Comprehensive Cancer Network ® (NCCN ®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) to recommend...Read more
First coronary drug-coated balloon in U.S. provides safe, effective alternative to treat coronary in-stent restenosis and reduce risk of reoccurrence MARLBOROUGH, Mass., March 1, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and Drug Administration (FDA) approval for the AGENT™ Drug-Coated Balloon (DCB), which is indicated to treat coronary in-stent restenosis (ISR) in...Read more
SIMLANDI is the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. SIMLANDI is the first biosimilar approval under the strategic partnership between Alvotech and Teva in the U.S. market SIMLANDI will qualify for interchangeable exclusivity in the U.S. for some concentration strengths REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ:...Read more
SCD-PED (Pediatric) is the first FDA-approved product in the Company’s Quelimmune™ product family DENVER, Feb. 22, 2024 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, announces that the U.S. Food and Drug Administration (FDA) has granted a Humanitarian Device Exemption (HDE) Approval Order...Read more
Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility HORSHAM, Pa., Feb. 20, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W)...Read more
Approval based on FLAURA2 results which showed TAGRISSO plus chemotherapy extended median progression-free survival by nearly 9 months vs. standard of care WILMINGTON, Del. / Feb 16, 2024 / Business Wire / AstraZeneca’s TAGRISSO® (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small...Read more
AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy AMTAGVI deploys patient-specific immune cells that recognize and fight cancer SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing and delivering novel polyclonal tumor...Read more
Approval is based on data from the NIH-sponsored Phase III OUtMATCH study, which showed a significantly higher proportion of food allergy patients as young as 1 year treated with Xolair could tolerate small amounts of peanut, milk, egg and cashew without an allergic reaction, compared to placebo More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once Detailed OUtMATCH...Read more
Masimo MightySat® Medical Provides Clinically Proven Masimo SET® Pulse Oximetry to Consumers for Medical Use Without a Prescription IRVINE, Calif. / Feb 13, 2024 / Business Wire / Masimo (NASDAQ: MASI) announced today FDA clearance of MightySat® Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available Over-The-Counter (OTC) direct to consumers without a prescription. All other pulse oximeters...Read more
12 Weeks of Treatment with EOHILIA May Address Significant Unmet Needs of Patients 11 Years of Age and Older EoE Is a Chronic Disease That Can Significantly Impact Patients, with Esophageal Inflammation and Intermittent Symptoms of Choking and Difficult or Painful Swallowing OSAKA, Japan & CAMBRIDGE, Mass. / Feb 12, 2024 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA)...Read more
Strong clinical evidence base, largest volume of real-world use reinforce safety, efficacy and efficiency advantages of the system MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the FARAPULSE™ Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System is indicated for the isolation of pulmonary veins in...Read more
New Indication Delivers on Takeda’s Commitment to Expanding its Broad and Diverse Immunoglobulin (IG) Portfolio to Meet the Needs of People Living with CIDP Approval Supported by Phase 3 ADVANCE-CIDP Open-label Study Data Demonstrating Safety and Efficacy as an Intravenous Therapy for Adults with CIDP GAMMAGARD LIQUID [Immune Globulin Infusion (Human) 10% Solution] is the Only Intravenous IG (IVIG) Approved for the Treatment of Multiple...Read more
Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo Expanded indication marks second disease for which Dupixent is approved in children this young, underscoring the commitment to bringing therapies to young patients with significant unmet needs EoE is one of five FDA-approved indications for Dupixent in the U.S. for which type...Read more
Expanded indication for ZYNRELEF now covers approximately 13 million procedures annually SAN DIEGO, Jan. 23, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company, today announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® (bupivacaine and meloxicam) extended-release solution to expand the...Read more
Approximately 1,000 patients in the U.S. 12 years of age and older are now eligible for this one-time treatment ZUG, Switzerland and BOSTON, Jan. 16, 2024 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel...Read more
Approximately 1,000 patients in the U.S. 12 years of age and older are now eligible for this one-time treatment BOSTON / Jan 16, 2024 / Business Wire / Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited cell therapy, for the treatment of transfusion-dependent beta thalassemia (TDT) in...Read more
HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only up to Once Monthly (every 2, 3 or 4 weeks) Subcutaneous Immunoglobulin (SCIG) Infusion to Treat CIDP, Can Be Administered by a Healthcare Professional or Self-Administered after Appropriate Training Approval Based on Phase 3 ADVANCE-CIDP 1 Study Demonstrating a Statistically Significant Difference in Relapse Rate in Favor of HYQVIA Versus Placebo...Read more
KEYTRUDA is the first and only anti-PD-1 therapy approved in combination with chemoradiotherapy for these patients Approval marks third FDA-approved indication for KEYTRUDA in cervical cancer and 39th indication for KEYTRUDA in the US RAHWAY, N.J. / Jan 12, 2024 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA,...Read more
Rechargeable neurostimulator joins the Medtronic Percept™ family – the first and only deep brain stimulation system with sensing, directionality, and advanced programming. DUBLIN, Jan. 8, 2024 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced the U.S. Food and Drug Administration (FDA) approval of its Percept™ RC Deep Brain Stimulation (DBS) system. The rechargeable...Read more
Compass Therapeutics is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. The company's scientific focus is on the relationship between angiogenesis, the immune system, and tumor growth...
CLICK TO LEARN MORE