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
BOULDER, CO / ACCESSWIRE / September 17, 2024 / Sonoma Pharmaceuticals, Inc. (NASDAQ:SNOA), a global healthcare leader developing and producing patented Microcyn® technology based stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, and animal health care, today announced it has received a new 510(k) clearance from the U.S. Food...Read more
Breakthrough Therapy Designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s) BridgeBio will leverage the benefits of Breakthrough Therapy Designation to expedite the development and regulatory review of infigratinib in the United States and...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
LEXINGTON, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO) (the “Company”), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) to market its FDA-cleared T2Candida® Panel for pediatric patients. The Company expects to immediately begin marketing and selling the T2Candida Panel...Read more
FDA evaluated RMAT application based on positive clinical data from ongoing Phase 1 study of P-BCMA-ALLO1; new clinical data from the study will be presented at the 21st International Myeloma Society Annual Meeting this month RMAT designation recognizes potential of P-BCMA-ALLO1 to address significant unmet needs of multiple myeloma patients and enables increased dialogue with FDA throughout the development process SAN DIEGO,...Read more
CAMBRIDGE, Mass., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to evaluate its CD19xCD3 bispecific T cell engager, CLN-978, for the treatment of systemic lupus erythematosus (SLE). “We are...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
U.S. FDA Orphan Drug exclusivity provides seven years of market exclusivity for YORVIPATH in the United States for the treatment of hypoparathyroidism in adults COPENHAGEN, Denmark, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced that the United States Food & Drug Administration (FDA) has granted Orphan Drug exclusivity to YORVIPATH® (palopegteriparatide, developed as TransCon PTH),...Read more
Elraglusib is a Class-Leading GSK-3β Inhibitor with a Novel, Multimodal Mechanism of Action in Multiple Refractory Cancer Trials Orphan Drug Designation in Soft Tissue Sarcomas Expands Company’s Potential to Address Cancers with High Unmet Medical Need CHICAGO and FORT WORTH, Texas, Sept. 11, 2024 (GLOBE NEWSWIRE) -- Actuate Therapeutics, Inc. (NASDAQ: ACTU) (“Actuate” or the “Company”), a clinical-stage biopharmaceutical company,...Read more
CAMBRIDGE, Mass., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the treatment of myelodysplastic syndromes (MDS). “Receiving orphan drug...Read more
Receipt of RMAT Designation is based on preliminary clinical evidence from the CANaspire Phase 1/2 clinical trial, which showed functional improvements in all dosed patients indicating that BBP-812 has potential to address the unmet needs of individuals with Canavan disease BridgeBio will leverage the benefits of RMAT designation, including early and more frequent interactions with the FDA, to establish an Accelerated Approval pathway...Read more
PALISADE Phase 3 results demonstrate plozasiran reduced triglycerides by 80% from baseline and reduced the risk of developing acute pancreatitis by 83% in patients with genetically confirmed and clinically diagnosed FCS1 PASADENA, Calif. / Sep 10, 2024 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to...Read more
If approved, neffy 1 mg will be the first and only needle-free epinephrine treatment available for younger school-aged children The submission of neffy 1 mg sNDA follows FDA approval on August 9, 2024, of neffy (2 mg) for the treatment of Type I Allergic Reactions, including anaphylaxis, in adults and children who weigh 30 kg (66 lbs.) or greater SAN DIEGO, Sept. 09, 2024 (GLOBE NEWSWIRE) -- ARS Pharmaceuticals,...Read more
ATLANTA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec®, an innovative diagnostic solution for checking the...Read more
GAITHERSBURG, Md., Sept. 09, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). Descartes-08, Cartesian’s lead mRNA cell therapy...Read more
ALACHUA, Fla. and TAMPA, Fla., Sept. 06, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, announced that it has completed the rolling submission process for its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Avance Nerve Graft®. “I am proud of the significant progress our team has made...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
BASKING RIDGE, N.J., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Lisata Therapeutics, Inc. (Nasdaq: LSTA) (“Lisata” or the “Company”), a clinical-stage pharmaceutical company developing innovative therapies for the treatment of advanced solid tumors and other serious diseases, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to certepetide for the treatment of...Read more
SEATTLE, Sept. 05, 2024 (GLOBE NEWSWIRE) -- Perspective Therapeutics, Inc. (“Perspective” or the “Company”) (NYSE AMERICAN: CATX), a radiopharmaceutical company that is pioneering advanced treatment applications for cancers throughout the body, today announced that the U.S. Food and Drug Administration (the “FDA”) granted Fast Track Designation for the development of 212Pb VMT01 for the diagnosis and treatment of patients with...Read more
MODD1 is a patch pump for ALL adults with Type 1 and Type 2 diabetes Designed to be simpler and more affordable to expand access to diabetes technology for previously underserved communities Commercial availability expected in early 2025 SAN DIEGO, CA / ACCESSWIRE / September 4, 2024 / Modular Medical, Inc. (the "Company" or "Modular Medical") (NASDAQ:MODD), an insulin delivery system technology company preparing to...Read more
NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the Company’s New Drug Application (NDA) for AXS-07 for the acute treatment of migraine. The FDA designated the...Read more
ENGLEWOOD, Colo., Sept. 3, 2024 /PRNewswire/ -- Zynex Inc. (NASDAQ: ZYXI), a leading medical technology company specializing in non-invasive medical devices for pain management and rehabilitation, today announced FDA clearance of its new TensWave device. The TensWave device, by prescription only, builds on Zynex's strong legacy of innovation in pain management. It offers a user-friendly, portable design that can be easily integrated...Read more
SAN DIEGO / Sep 03, 2024 / Business Wire / Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a global messenger RNA medicines company focused on the development of infectious disease vaccines and addressing unmet medical needs within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has issued a “Study May Proceed” notification for the Company’s Investigational...Read more
Fast Track designation is designed to expedite clinical development and regulatory review timelines Additional FDA designation for CB-010 following earlier RMAT and Fast Track designations in B-NHL CB-010 GALLOP Phase 1 trial in patients with LN and ERL is on track to initiate by YE 2024 CB-012 AMpLify Phase 1 trial advancing in dose escalation BERKELEY, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) --...Read more
Authorization expands use of bezisterim in a Phase 2, placebo-controlled, multicenter trial assessing bezisterim’s impact on neurological symptoms associated with long COVID Key milestone reached ahead of schedule, with BioVie on track to receive additional $12.6 million of award from the U.S. Department of Defense and initiate the Phase 2 trial Recent Centers for Disease Control and Prevention survey estimated over 5% of U.S. adults...Read more
LOS ALTOS, Calif., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC) for the treatment of hyperphosphatemia in patients...Read more
If approved, sebetralstat will be the first, oral on-demand treatment for HAE FDA PDUFA goal date of June 17, 2025 CAMBRIDGE, Mass. & SALISBURY, England / Sep 03, 2024 / Business Wire / KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for...Read more
While 9 out of 10 people with diabetes are living with T2D, many of the automated insulin delivery solutions currently on the market were designed for people living with T1D. 300-unit insulin reservoir is more suitable for people with T2D who are interested in moving from multiple daily injections (MDI) to pump therapy, based on an average daily dose of 95.9 units of insulin.1 PARSIPPANY, N.J., Sept. 03, 2024 (GLOBE NEWSWIRE) --...Read more
Novavax expects pre-filled syringes will be broadly available in thousands of locations across the U.S. Novavax's vaccine is the only protein-based option available in the U.S. for use in individuals aged 12 and older to prevent COVID-19 GAITHERSBURG, Md., Aug. 30, 2024 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the Novavax...Read more
GAITHERSBURG, Md., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expansion of the indication for ACAM2000®, (Smallpox and Mpox (Vaccinia) Vaccine, Live) to include prevention of mpox disease in individuals determined to be at high risk for mpox infection....Read more
FDA Final Approval to Precision Dosing for GLOPERBA® Label. We believe GLOPERBA® is the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults. Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States1. As gout cases increase every year, treatment requirements increase. According to data gathered by Evaluate...Read more
SUNNYVALE, Calif., Aug. 29, 2024 (GLOBE NEWSWIRE) -- BioCardia, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, announced today that the Food and Drug Administration (FDA) has cleared BioCardia to market the Morph DNA Steerable Introducer product family, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic...Read more
FORT LEE, N.J., Aug. 29, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) (“Nuvectis” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of innovative precision medicines for the treatment of serious conditions of unmet medical need in oncology, today announced that NXP800 was granted Orphan Drug Designation by the United States Food and Drug Administration (“FDA”) for the treatment of...Read more
Marks first FDA submission for nipocalimab, an investigational treatment that binds with high affinity and specificity to block FcRn and reduce levels of autoantibodies Filing based on the Phase 3 Vivacity-MG3 program, the first-and-only study results in the class demonstrating sustained disease control over 24 weeks in antibody positive adult patients: anti-AChR+, anti-MuSK+, anti-LRP4+ SPRING HOUSE, Pa., Aug. 29, 2024...Read more
PI-2620 is in Phase 3 development in Alzheimer’s disease by AC Immune’s partner, LMI This Fast Track designation applies across Alzheimer’s disease, progressive supranuclear palsy, and corticobasal degeneration Follows two previous Fast Track designations for ACI-35.030 and ACI-24.060 active immunotherapies Affirms AC Immune’s leadership and commitment to bringing precision medicine to the management of neurodegenerative...Read more
PDUFA target action date of February 28, 2025 EU Marketing Authorization Application also validated by European Medicines Agency STAMFORD, Conn., Aug. 28, 2024 (GLOBE NEWSWIRE) -- SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage biopharmaceutical company focused on severe rare diseases and cancer, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug...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
PDUFA target action date set for December 27, 2024 FDA currently plans to hold an Advisory Committee meeting REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug...Read more
Label expansion makes Omnipod 5 commercially available to 6 million people living with insulin-requiring type 2 diabetes Omnipod 5 is the first and only automated insulin delivery (AID) system indicated for both type 1 and type 2 diabetes ACTON, Mass. / Aug 26, 2024 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the global leader in tubeless insulin pump technology with its Omnipod® brand of products,...Read more
Label expansion sought to treat younger children with Bardet-Biedl syndrome or POMC/LEPR deficiency FDA sets PDUFA goal date of December 26, 2024 BOSTON, Aug. 26, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug...Read more
First Restorative Biologic Cartilage Repair Product Approved for Arthroscopic Administration Targets the Largest Segment of MACI’s $3 Billion Addressable Market CAMBRIDGE, Mass., Aug. 26, 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 supplemental Biologics...Read more
Neuroblastoma is rare but is the most common infancy malignancy with a median age of diagnosis of 17 months. In the U.S., it accounts for up to around 10% of all childhood cancer cases and 15% of pediatric cancer-related deaths[1],[2] Orphan Drug designation provides for seven-years' marketing exclusivity should opaganib be approved in neuroblastoma and may confer additional benefits such as accelerated development and review times,...Read more
Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with relapsed/refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) SAN MATEO, Calif. / Aug 26, 2024 / Business Wire / BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track...Read more
SciSparc to conduct the trial at the Yale Child Study Center at the Yale School of Medicine in the USA, Hannover Medical School in Germany and Tel Aviv Sourasky Medical Center in Israel TEL AVIV, Israel, Aug. 23, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the...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
New investigational new drug (IND) application cleared to proceed by the US FDA for a Phase 1/2 clinical study of ATR-04 for moderate to severe EGFR inhibitor (“EGFRi”) associated dermal toxicity. There are an estimated 150,000 patients with EGFRi-associated skin rash in the US, representing a >$1 billion global market size. Preclinical data show ATR-04 reduces IL-36γ and Staphylococcus aureus, key drivers of EGFRi-associated skin...Read more
HealthCCSng V2.0 introduces additional ‘zero calcium’ categorization of coronary artery calcium (CAC) and generates a numerical calcium score with corresponding CAC detection category output Marks second FDA 510(k) clearance of HealthCCSng product PETACH TIKVA, Israel, Aug. 21, 2024 (GLOBE NEWSWIRE) -- NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that...Read more
Acceptance based on Phase 3 CheckMate -9DW trial results demonstrating improved survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to investigator’s choice of lenvatinib or sorafenib in this patient population The U.S. Food and Drug Administration assigned a target action date of April 21, 2025 PRINCETON, N.J. / Aug 21, 2024 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug...Read more
SAN JOSE, Calif., Aug. 21, 2024 (GLOBE NEWSWIRE) -- PROCEPT BioRobotics® Corporation (Nasdaq: PRCT) (the “Company”), a surgical robotics company focused on advancing patient care by developing transformative solutions in urology, today announced FDA 510(k) clearance of its next-generation platform, the HYDROS™ Robotic System. Leveraging insights from over 50,000 procedures, HYDROS features FirstAssist AI™ treatment planning, advanced...Read more
TARRYTOWN, N.Y., Aug. 20, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for linvoseltamab in relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies. This anticipated outcome was previously disclosed during...Read more
SANTA CLARA, Calif., Aug. 20, 2024 (GLOBE NEWSWIRE) -- SI-BONE, Inc., (Nasdaq: SIBN), a Silicon Valley-based medical device company dedicated to providing surgical solutions for sacropelvic disorders, announces FDA 510(k) clearance of the iFuse TORQ TNT™ Implant System (TNT). The TNT implant system is designed to meet the specific anatomical and bone mineral density needs of the sacrum and ilium and will serve as the next generation...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
PDUFA Target Action Date of February 1, 2025 ROCKVILLE, Md., Aug. 19, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of the new drug application (NDA) for its...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
Based on ADRIATIC Phase III trial which demonstrated statistically significant and clinically meaningful overall survival and progression-free survival benefit WILMINGTON, Del. / Aug 15, 2024 / Business Wire / AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI® (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose...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
PRINCETON, N.J. / Aug 14, 2024 / Business Wire / UroGen Pharma Ltd. (Nasdaq: URGN), a leading biotech company specializing in novel therapies for urothelial and specialty cancers, today announced the successful completion of its New Drug Application (NDA) submission for investigational drug UGN-102, (mitomycin) for intravesical solution, a significant step forward in potentially addressing the urgent need for innovative treatments for...Read more
HOUSTON / Aug 14, 2024 / Business Wire / Kiromic BioPharma, Inc. (OTCQB: KRBP) (“Kiromic” or the “Company”) announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Deltacel™ (KB-GDT-01), the Company’s allogeneic, off-the-shelf, Gamma Delta T-cell (GDT) therapy. The designation was awarded for KB-GDT-01 in combination with low-dose radiation therapy for the treatment of patients with metastatic...Read more
The application was evaluated based on the positive clinical outcomes in patients treated in Germany under the named-patient program The Regenerative Medicine Advanced Therapies designation allows Kyverna to leverage on more expedited meetings and more senior FDA leadership involvement throughout the development cycle for KYV-101 EMERYVILLE, Calif., Aug. 12, 2024 /PRNewswire/ -- Kyverna Therapeutics, Inc. (Kyverna), a...Read more
Designation highlights significant unmet needs in DMD; dystrophin data from potentially registrational FORWARD-53 trial of WVE-N531 are on track for 3Q 2024 In previous Part A trial, WVE-N531 achieved industry-leading exon skipping of 53% and muscle tissue concentrations that were approximately 20-30 times higher than those reported by exon skipping technologies leveraging muscle delivery conjugates CAMBRIDGE, Mass., Aug. 12, 2024...Read more
Secure Bluetooth® Connectivity Allows Continuous, Accurate Wrist-based Measurements to be Seamlessly Relayed to Caregivers via the Masimo Secure Health Data Cloud IRVINE, Calif. / Aug 12, 2024 / Business Wire / Masimo (NASDAQ: MASI) today announced that the Masimo W1® medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet® comprehensive telemonitoring solution. Masimo W1...Read more
SAN DIEGO, Aug. 12, 2024 (GLOBE NEWSWIRE) -- LENZ Therapeutics, Inc. (Nasdaq: LENZ or “LENZ” or the “Company”), a late clinical-stage biopharmaceutical company focused on developing the first and only aceclidine-based eye drop to improve near vision in people with presbyopia, today announced that the Company has submitted a New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic...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
2nd quarter conference call to be held Tuesday, August 13th, at 8:30 a.m. ET DURHAM, N.C., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License...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
Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision...Read more
SAT-3247 is a proprietary, oral small molecule drug being developed by Satellos as a novel treatment to regenerate skeletal muscle which is lost in Duchenne muscular dystrophy (DMD) DMD is a rare genetic disorder characterized by progressive muscle degeneration and weakness Satellos has also received Orphan Drug Designation from the FDA for SAT-3247 Initiation of a Phase 1 clinical trial of SAT-3247 anticipated in Q3 2024 TORONTO /...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
Designation based on preliminary clinical evidence from ongoing NGN-401 clinical trial that shows potential to address unmet medical needs in Rett syndrome RMAT designation provides an opportunity for an Accelerated Approval pathway under the 21st Century Cures Act, and is in addition to NGN-401’s selection by the FDA for the START Pilot Program NEW YORK / Aug 07, 2024 / Business Wire / Neurogene Inc. (NASDAQ: NGNE), a clinical-stage...Read more
The FDA assigned a Prescription Drug User Fee Act target action date of April 3, 2025 Application is based on results from the phase 3 CABINET pivotal trial, in which cabozantinib provided a statistically significant and clinically meaningful improvement in progression-free survival versus placebo ALAMEDA, Calif. / Aug 06, 2024 / Business Wire / Exelixis, Inc. (Nasdaq: EXEL) today announced that its supplemental New Drug...Read more
Second rare disease program with RZ358 in Phase 3 development Follows successful treatment of multiple patients with tumor hyperinsulinism under the Company’s Expanded Access Program REDWOOD CITY, Calif., Aug. 05, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT) (“Rezolute” or the “Company”), a late-stage biopharmaceutical company committed to developing novel, transformative therapies for serious rare diseases, today...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
CELEBRATION, Fla., Aug. 02, 2024 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a rare disease therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) Genetic Metabolic Diseases Advisory Committee (GeMDAC) voted favorably (11 yes, 5 no) that the data support that arimoclomol is effective in the treatment of patients with Niemann-Pick disease type C (NPC). “We are...Read more
C4 Therapeutics is pioneering a new class of small-molecule drugs that selectively destroy disease-causing proteins via degradation using the innate machinery of the cell. This targeted protein degradation approach offers advantages over traditional drugs, including the potential to treat a wider range of diseases...
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