Based on MATTERHORN Phase III trial results which showed a 29% reduction in the risk of progression, recurrence or death and a 22% reduction in the risk of death for the IMFINZI regimen vs. chemotherapy alone WILMINGTON, Del. / Nov 26, 2025 / Business Wire / AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) has been approved in the US for...Read more
Approximately 25 non-ambulatory participants will receive sirolimus as part of the regimen in Cohort 8 of the ENDEAVOR study, which is expected to begin before the end of the year The enhanced immunosuppressive regimen is designed to mitigate the risk of acute liver injury (ALI) and acute liver failure (ALF) associated with AAV gene therapy Decisions regarding resuming commercial dosing for this population will be made in collaboration...Read more
LEQEMBI IQLIK, if approved for initiation dosing, would be the first and only anti-amyloid treatment to offer at-home injection from the start of therapy to help patients and care partners treat this progressive, relentless disease TOKYO and CAMBRIDGE, Mass., Nov. 25, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts,...Read more
CAMBRIDGE, Mass., Nov. 24, 2025 /PRNewswire/ -- NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed the review of the Investigational New Drug (IND) amendment application and authorized the Company to initiate the pivotal Phase 3...Read more
Becomes the first and only FDA-cleared seizure detection algorithm for pre-term neonates through adults enabling rapid bedside detection, diagnosis, and treatment of non-convulsive seizures SUNNYVALE, Calif., Nov. 24, 2025 (GLOBE NEWSWIRE) -- CeriBell, Inc. (Nasdaq: CBLL) (“Ceribell”), a medical technology company focused on transforming the diagnosis and management of patients with serious neurological conditions, today announced...Read more
Tonix plans to initiate potential pivotal Phase 2 HORIZON study of TNX-102 SL in adults with major depressive disorder in mid-2026 More than 21 million US adults experience a major depressive episode each year CHATHAM, N.J., Nov. 24, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company, today announced the U.S. Food and Drug...Read more
EUA to Treat Cats for NWS Issued Prior to Fly Being Detected in the U.S.; Action Prepares Veterinarians and Pet Owners with Treatment Options First U.S. Food and Drug Administration Emergency Use Authorization (EUA) granted for New World screwworm in cats, reinforcing Elanco's leadership in feline innovation Action reinforces the FDA's commitment to act swiftly against emerging animal health threats Scientific studies...Read more
PADCEV plus Keytruda is the first and only approved perioperative treatment regimen that can significantly improve survival over current standard of care (surgery alone) in cisplatin-ineligible patients with muscle-invasive bladder cancer Approval is based on unprecedented data from the pivotal Phase 3 EV-303 trial showing a 60% reduction in the risk of disease recurrence, progression or death and a 50% reduction in the risk of death...Read more
Represents the first PD-1 inhibitor plus ADC regimens for this patient population RAHWAY, N.J. / Nov 21, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) in combination with Padcev® (enfortumab vedotin-ejfv), as...Read more
RICHMOND, Calif., Nov. 21, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has accepted Sangamo’s request for a rolling submission and review of the Biologics License Application (BLA) for isaralgagene civaparvovec, or ST-920, a wholly owned investigational gene therapy for the treatment of adults with Fabry disease. This...Read more
FDA Response Streamlines Path to Commercial Production of PF614 SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written...Read more
Following Priority Review, the U.S. FDA granted HYRNUO® (sevabertinib) approval for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. WHIPPANY, N.J. / Nov 20, 2025 / Business Wire / Bayer announced today...Read more
EDAP Receives FDA 510(k) Clearance for Latest Evolution of Focal One Robotic HIFU AUSTIN, Texas, November 20, 2025 - EDAP TMS SA (Nasdaq: EDAP), the global leader in robotic energy-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for new ultrasound imaging and workflow enhancements to the Focal One High Intensity Focused Ultrasound (HIFU) system, further strengthening...Read more
PRINCETON, N.J. and TOKYO and CAMBRIDGE, Mass., Nov. 20, 2025 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Therapeutics, Inc. (Nasdaq: CGEM) today announced the companies have initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval of zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase...Read more
NDA based on data from global ARROS-1 Phase 1/2 clinical trial FDA assigns PDUFA target action date of September 18, 2026 CAMBRIDGE, Mass., Nov. 19, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing...Read more
First and only FDA-approved treatment for RVO indicated for up to every 8-week dosing after an initial monthly dosing period Monthly dosing option in all approved indications provides greater dosing flexibility for more personalized patient care TARRYTOWN, N.Y., Nov. 19, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA...Read more
Global Confirmatory Phase 3 DeLLphi-304 Trial Showed IMDELLTRA Reduced Risk of Death by 40% Compared to Chemotherapy Underscores IMDELLTRA as a Recognized Standard of Care Treatment for Patients With Extensive Stage Small Cell Lung Cancer That Has Progressed THOUSAND OAKS, Calif., Nov. 19, 2025 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that the U.S. Food and Drug Administration (FDA) has granted full approval to...Read more
Dexcom Smart Basal is designed to make basal insulin initiation and management simpler and more personalized for users and their healthcare providers.* Dexcom Smart Basal is FDA cleared and now the first and only CGM-integrated basal insulin dosing optimizer for adults aged 18 and older with Type 2 diabetes who are using long-acting insulin.1 SAN DIEGO / Nov 19, 2025 / Business Wire / DexCom, Inc. (NASDAQ: DXCM), the global leader in...Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapyIn the Phase 3 EPCORE® FL-1 trial, EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2 with approximately 3 out of 4...Read more
REDEMPLO is the first and only FDA-approved medicine to be studied in patients with genetically confirmed and clinically diagnosed FCS People living with FCS have extremely high triglyceride levels and a substantially higher risk of acute pancreatitis and related long-term complications, often resulting in a reduced quality of life The FDA approval is based on positive results from the Phase 3 PALISADE study where REDEMPLO significantly...Read more
EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is the first and only bispecific-based therapy approved by the FDA for follicular lymphoma in the second-line setting In the Phase 3 EPCORE® FL-1 trial, fixed duration EPKINLY + R2 demonstrated significantly superior progression-free survival and overall response rates compared to standard of care R2, with approximately three out of four patients achieving a complete response This...Read more
MALVERN, Pa., Nov. 18, 2025 (GLOBE NEWSWIRE) -- Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD), today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Type C meeting in January 2026 to discuss the Company's pathway for...Read more
MINNEAPOLIS, Nov. 17, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the completion of the submission of its New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for gedatolisib in hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), advanced breast...Read more
Prescription Drug User Fee Act (PDUFA) target action date set for June 29, 2026 If approved, ZORYVE cream 0.3% would be the first and only topical PDE4 inhibitor indicated for plaque psoriasis in children as young as 2 WESTLAKE VILLAGE, Calif., Nov. 17, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in...Read more
SKNJCT-003 Doxorubicin containing Microneedle Array (D-MNA) clinical development program to non-invasively treat BCC aligns with national priorities of public health impact, unmet medical need, access, affordability, domestic manufacturing and rare-disease alignment. PHILADELPHIA, PENNSYLVANIA / ACCESS Newswire / November 17, 2025 / Medicus Pharma Ltd. (NASDAQ:MDCX) ("Medicus" or the "Company"), a biotech/life sciences company...Read more
SHANGHAI & JERSEY CITY, N.J. / Nov 17, 2025 / Business Wire / Shanghai Henlius Biotech, Inc. (2696.HK), and Organon (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for POHERDY® (pertuzumab-dpzb) 420 mg/14 mL injection for intravenous use, an interchangeable biosimilar to PERJETA (pertuzumab), for all indications of the reference product.1 POHERDY is the...Read more
CAMBRIDGE, Mass. / Nov 14, 2025 / Business Wire / Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced an update to the prescribing information for ELEVIDYS (delandistrogene moxeparvovec-rokl), the only approved gene therapy for Duchenne muscular dystrophy (DMD). As previously disclosed, the ELEVIDYS label now includes several key updates, including: A boxed warning for...Read more
Targets $3 Billion "Almost-Pumper" Market with First Simplified and Removable/Replaceable Insulin Patch Pump Aims to Improve Patient and Clinician Experience for the Care of Diabetes SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Modular Medical, Inc. (NASDAQ:MODD) ("Modular Medical" or the "Company") today announced the 510(k) premarket submission of its next generation Pivot™ tubeless patch pump to the U.S. Food and...Read more
ROSA® Knee with OptimiZe™ Offers Personalized Surgical Planning and Drives Confidence in Delivering Accurate and Reproducible Outcomes1 WARSAW, Ind., Nov. 14, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of ROSA® Knee with OptimiZe™, an enhanced version of its ROSA® Knee System that...Read more
IRVINE, CA / ACCESS Newswire / November 13, 2025 / enVVeno Medical Corporation (NASDAQ:NVNO) ("enVVeno" or the "Company"), a company setting new standards of care for the treatment of deep venous disease, today announced that it has received an unfavorable decision from the U.S. Food & Drug Administration ("FDA") in response to its supervisory appeal of the not-approvable letter it received on August 19, 2025 in response to its...Read more
First-to-market complex injectable with expected launch in Q1 2026 BRIDGEWATER, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced the U.S. Food and Drug Administration (FDA) has approved the Company’s iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque® (iohexol) injection. Amneal expects to launch the product in the...Read more
NPM1 mutations, one of the most common genetic drivers of AML, are now actionable for patients Acute unmet need in R/R NPM1-mutated AML defined by historically poor outcomes and low survival rates at relapse FDA grants full approval of KOMZIFTI ahead of PDUFA target action date Approval is based on the KOMET-001 trial, in which KOMZIFTI demonstrated deep responses, a potentially best-in-class safety profile, once-daily...Read more
Vancouver, Canada, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Clearmind Medicine Inc. (Nasdaq: CMND), (FSE: CWY0) (“Clearmind” or the "Company"), a clinical-stage biotech company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated health problems, today announced that it has received final approval from the Hadassah Medical Center, Jerusalem, Israel, for its ongoing Phase 1/2a clinical trial...Read more
Prescription Drug User Fee Act (PDUFA) goal date of December 31, 2025 ISELIN, N.J., Nov. 13, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on enhancing the standard of care for bevacizumab for the treatment of retina diseases, today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the Biologics License Application (BLA)...Read more
RED BANK, N.J., Nov. 13, 2025 /PRNewswire/ -- Tharimmune, Inc. (Nasdaq: THAR) ("Tharimmune" or the "Company"), a digital asset treasury company with a clinical-stage biotechnology function, today announced an update from the biotechnology side of the business. Its lead clinical asset, TH104 (nalmefene buccal film), received positive feedback from the U.S. Food and Drug Administration (FDA) on the Company's submitted simulation modeling...Read more
Deep TMS™ becomes first and only TMS device cleared in treatment of patients aged 15 to 86 suffering from depression BURLINGTON, Mass. and JERUSALEM, Israel, Nov. 13, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that the U.S. Food and Drug Administration (FDA) has...Read more
First-of-its-kind, automated system delivers increased sensitivity, specific identification of disease markers and improved laboratory workflow to support fast, confident diagnoses WALTHAM, Mass. / Nov 12, 2025 / Business Wire / Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced 510(k) clearance of the EXENT® Analyser and Immunoglobulin Isotypes (GAM) Assay**, a first-of-its-kind automated...Read more
Northvale, New Jersey--(Newsfile Corp. - November 12, 2025) - Elite Pharmaceuticals, Inc. (OTCBB: ELTP) ("Elite" or the "Company"), a specialty pharmaceutical company developing niche generic products, today announced that it received approval from the US Food and Drug Administration (FDA) for an Abbreviated New Drug Application (ANDA) for a generic version of Requip XL® (Ropinirole Extended-Release Tablets USP), with strengths...Read more
PRINCETON, N.J., Nov. 11, 2025 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq: IART), a leading global medical technology company, is pleased to announce the FDA 510(k) clearance for use of its CUSA® Clarity Ultrasonic Surgical Aspirator System for cardiac surgeries. The recent clearance for specific cardiac indications encompasses the debridement of unwanted tissue in cardiac surgeries, including valve replacement...Read more
Passing of key audits with zero findings and completion of Day-100 meeting are significant milestones in the FDA PMA process as the Company enters final stages of FDA review process for its Allurion Smart Capsule Exchange of outstanding debt for shares of convertible preferred stock would result in Company being debt-free $5M private placement financing with participation from new and existing stockholders and a strategic partner with...Read more
Non-invasive capsule endoscopy system aims to enable earlier detection of pancreatic ductal adenocarcinoma - among the most fatal cancers worldwide SARATOGA, Calif., Nov. 10, 2025 (GLOBE NEWSWIRE) -- CapsoVision, Inc. (NASDAQ: CV), a commercial-stage medical technology company developing advanced imaging and AI-enabled capsule endoscopy solutions, today announced that it has submitted an application to the U.S. Food and Drug...Read more
ST. LOUIS, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it received U.S. Food and Drug Administration 510(k) clearance for its latest generation robotic system, GenesisX™. GenesisX is the latest advance in endovascular surgical robotics, building upon the established benefits of Robotic Magnetic...Read more
By adding compatibility with the Android platform, Tandem Mobi is expanding its connected-care ecosystem SAN DIEGO / Nov 10, 2025 / Business Wire / Tandem Diabetes Care, Inc. (Nasdaq: TNDM), a global insulin delivery and diabetes technology company, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Android version of the Tandem Mobi mobile app. Tandem Mobi, the world’s smallest, durable automated insulin...Read more
Venus NOVA is the first product clearance from the Company’s new R&D strategy TORONTO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Venus Concept Inc. (“Venus Concept” or the “Company”), a global leader in medical aesthetic technology, announced today that it has received a 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market the Venus NOVA™, the Company’s next-generation multi-application platform designed to...Read more
The planned confirmatory Phase 3 trial, TELLOMAK 3, aims to demonstrate efficacy of lacutamab in patients with Sézary syndrome (SS) and Mycosis fungoides (MF), who failed at least one prior line of systemic therapy. The Company submitted the confirmatory Phase 3 TELLOMAK 3 protocol to the FDA, which completed its review with no further comments, clearing the study to proceed. The Company is progressing towards the initiation of the...Read more
Atacicept received FDA Breakthrough Therapy Designation for the treatment of IgAN ORIGIN Phase 3 trial met its primary endpoint at the prespecified interim analysis of proteinuria reduction with 46% reduction from baseline and 42% reduction vs placebo at week 36 (p<0.0001) If approved, atacicept would be the first B cell modulator targeting both BAFF and APRIL for IgAN; potential FDA approval in 2026 BRISBANE, Calif., Nov. 07,...Read more
FDA sets updated PDUFA goal date of March 20, 2026 Company to hold conference today at 8:00 a.m. BOSTON, Nov. 07, 2025 (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 Administration (FDA) has extended by three months the review period...Read more
Phase 3 AQUILA study showed DARZALEX FASPRO® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring Landmark approval supports earlier intervention and disease interception of multiple myeloma for the first time HORSHAM, Pa., Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA)...Read more
CAPLYTA®, in combination with an oral antidepressant, demonstrated superior efficacy with a favorable safety and tolerability profile consistent with established indications1,2 In pivotal trials, CAPLYTA® did not increase mean weight gain, metabolic changes, or reported sexual side effects1,2 In a six-month open-label extension safety study, safety profile was consistent with pivotal studies and 80% of MDD patients taking...Read more
This strategic filing with the FDA follows encouraging internal data and recent published studies supporting Nexalin’s frequency neurostimulator as a potential non-invasive therapy for cognitive disorders associated with Alzheimer’s disease HOUSTON, TX, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain,...Read more
Jupiter, Florida, Nov. 05, 2025 (GLOBE NEWSWIRE) -- Jupiter Neurosciences, Inc. (NASDAQ:JUNS), a clinical-stage pharmaceutical company developing JOTROL™, a patented resveratrol-based therapeutic platform targeting neuroinflammation and mitochondrial dysfunction, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 2a clinical trial of JOTROL™ in...Read more
Key Points Immuron receives U.S. Food and Drug administration (FDA) approval for IMM-529 Investigational New Drug (IND) application and clinical study may proceed FDA assigned an IND number (032095) for the IMM-529 application IND 32095 is Immuron’s Investigational new drug (IND) application for clinical development of IMM-529 as product to specifically prevent or treat Clostridioides difficile infection (CDI) and is now...Read more
The troriluzole clinical development program encompassed the first industry clinical trials to generate data showing therapeutic potential in patients with spinocerebellar ataxia (SCA), a rare genetic, inherited, life-threatening neurodegenerative disease with no treatment options. Compelling data from troriluzole's new drug application (NDA) included: a 3-year real-world evidence study (Study 206-RWE) showing slowing of...Read more
NEW YORK, Nov. 04, 2025 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that the U.S. Food & Drug Administration (FDA) has scheduled a meeting in early December to discuss Mesoblast's data on opioid reduction and cessation from its first Phase 3 study (MSB-DR003) of rexlemestrocel-L in patients with chronic low back pain (CLBP). In...Read more
New FDA feedback confirms clinical pathway for fixed multi-phage cocktail BX011, expanding development into diabetic foot infections (DFI) and unlocking a major commercial opportunity NESS ZIONA, Israel, Nov. 04, 2025 (GLOBE NEWSWIRE) -- BiomX Inc. (NYSE American: PHGE) (“BiomX” or the “Company”), a clinical-stage company advancing novel natural and engineered phage therapies targeting specific pathogenic bacteria, today announced...Read more
Announces NDV-01 9-Month Follow-up Safety and Efficacy Data in NMIBC FDA feedback supports 2 potential registrational trials – 1) a registrational trial in 2nd line refractory BCG-unresponsive NMIBC, and 2) a randomized controlled trial in intermediate-risk NMIBC. FDA Feedback also confirms no additional non-clinical studies are required. 9-month follow-up for NDV-01 showed a 92% overall response rate at any time in non-muscle...Read more
FDA feedback enables CervoMed to proceed with proposed endpoints, patient enrichment strategy, and other key aspects of Phase 3 trial design to support potential New Drug Application CervoMed is advancing preparations for global pivotal trial initiation in the second half of 2026 BOSTON, Nov. 04, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO) (CervoMed or the Company), a clinical-stage biotechnology company developing...Read more
ISELIN, N.J., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company focused on optimizing the standard of care for bevacizumab for the treatment of retina diseases, today announced it has re-submitted its Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ONS-5010, after receiving the official minutes from the FDA Type A meeting conducted in September...Read more
Successful completion of first trial phase enables continued pivotal trial of FemBloc, the only non-surgical permanent birth control, toward U.S. FDA approval $12 million senior secured convertible notes for total potential proceeds of $58 million, if all warrants are exercised for cash, reflecting strong investor confidence in Femasys’ women’s health mission ATLANTA, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Femasys Inc....Read more
Recurrent respiratory papillomatosis (RRP) is a rare HPV-related disease of the respiratory tract with significant unmet need INO-3107 previously received Orphan Drug and Breakthrough Therapy designations; BLA submitted under FDA's Accelerated Approval program Expect to receive file acceptance by year end 2025 with potential PDUFA date in mid-2026 if request for priority review granted PLYMOUTH MEETING, Pa., Nov. 3, 2025...Read more
LEXINGTON, Mass. and AMSTERDAM, Nov. 03, 2025 (GLOBE NEWSWIRE) -- uniQure N.V. (NASDAQ: QURE), a leading gene therapy company advancing transformative therapies for patients with severe medical needs, today announced that it received feedback from the U.S. Food and Drug Administration (FDA) during a recent pre-Biologics License Application (BLA) meeting regarding AMT-130, an investigational gene therapy for Huntington’s disease (HD)....Read more
PARADIGM: A Prospective rAndomized tRial Assessing the safety and effectiveness of the DurAVR® bIomimetic valve designed for physioloGic flow compared to CoMmercial TAVR devices MINNEAPOLIS and BRISBANE, Australia, Nov. 03, 2025 (GLOBE NEWSWIRE) -- Anteris announced today it has received U.S. Food and Drug Administration (FDA) approval to initiate PARADIGM, its global Investigational Device Exemption (IDE) clinical trial which is...Read more
Clearance expands menu and enables high-sensitivity troponin I measurement to aid in the diagnosis of myocardial infarction SAN DIEGO, Nov. 3, 2025 /PRNewswire/ -- The U.S. Food and Drug Administration ("FDA") has granted QuidelOrtho Corporation (Nasdaq: QDEL) ("QuidelOrtho"), a global leader of in vitro diagnostics, 510(k) clearance for the VITROS hs Troponin I Reagent Pack (the "VITROS hs Troponin I Assay"). The...Read more
BLA for veligrotug successfully submitted to the U.S. Food and Drug Administration (FDA) in late October following recent consultation with the agency Veligrotug’s Breakthrough Therapy Designation supports eligibility for potential Priority Review FDA decision whether to accept the BLA for filing is expected within 60 days of submission WALTHAM, Mass. / Nov 03, 2025 / Business Wire / Viridian Therapeutics, Inc....Read more
FRANKLIN LAKES, N.J., Nov. 3, 2025 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX) a leading global medical technology company, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Conformité Européenne (CE) marking in the European Union for its Enteric Bacterial Panel* (EBP) and Enteric Bacterial Panel plus* (EBP plus) for the BD COR™ System. By leveraging advanced...Read more
Positive end of Phase I meeting and agreement reached with FDA on pivotal study design for TSC-101 Dosed first solid tumor patients with multiplex TCR-T therapy; paused further enrollment to prioritize heme development; reiterates planned data readout in Q1 2026 Enacted ~30% workforce reduction to focus clinical development on heme program and initiate pre-clinical development of in vivo-engineered TCR-T for solid tumors Strategic...Read more
REYKJAVIK, Iceland, Nov. 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar...Read more
PDUFA Date Set for March 29, 2026 BEDFORD, Mass., Oct. 30, 2025 (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 established a Prescription Drug User Fee Act (PDUFA) date for LNTH-2501...Read more
Company’s first metered-dose inhalation (MDI) product and establishes a new growth vector for the Affordable Medicines segment BRIDGEWATER, N.J., Oct. 29, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has tentatively approved the Company’s Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol...Read more
Application based on positive results from Phase 3 PEGASUS study, which demonstrated statistically significant blood phenylalanine (Phe) lowering compared to diet alone FDA PDUFA target action date of Feb. 28, 2026 SAN RAFAEL, Calif., Oct. 29, 2025 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (Nasdaq: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the company's PALYNZIQ®...Read more
WARSAW, Ind., Oct. 28, 2025 (GLOBE NEWSWIRE) -- OrthoPediatrics Corp. (“OrthoPediatrics” or the “Company”) (Nasdaq: KIDS), a company focused exclusively on advancing the field of pediatric orthopedics, today announced the FDA approval of its 3P™ Pediatric Plating Platform™ Small-Mini System, the second of several systems in the 3P family. This represents the company’s 6th FDA approval in 2025. The 3P Small-Mini System is a versatile...Read more
PDUFA Date Set for August 13, 2026 BEDFORD, Mass., Oct. 28, 2025 (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 accepted its New Drug Application (NDA) for MK-6240, the company’s...Read more
Prioritized Regulatory Review Process in the U.S. Follows Japan PMDA Approval in September WARSAW, Ind., Oct. 28, 2025 /PRNewswire/ -- Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global medical technology leader, today announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's first-to-world iodine-treated total hip replacement system. This is the first product in...Read more
Cash runway into 2027, which is expected to support application resubmission, potential FDA approval, and launch of OLC LOS ALTOS, Calif., Oct. 28, 2025 (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 an update from its meeting with the U.S. Food and Drug Administration (FDA) and...Read more
Nutriband met with US FDA to obtain feedback on the Chemistry, Manufacturing, and Controls plans for AVERSA™ FENTANYL (abuse deterrent transdermal system) through commercialization. Nutriband received final meeting minutes from FDA and is incorporating the feedback into the development program as it moves forward to an IND filing in support of a Human Abuse Potential (HAP) clinical study for the product. ORLANDO, Fla., Oct. 28, 2025...Read more
Omvoh now offers patients a simplified maintenance experience with one monthly injection, replacing the previous two-injection regimen Omvoh single-injection dosing will be available for U.S. patients in early 2026 This is the third FDA approval for Omvoh this year, following approvals for Crohn's disease and a citrate-free formulation INDIANAPOLIS, Oct. 27, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today...Read more
CLOVER-2 Phase 1 Clinical Study Evaluating Iopofosine I 131 in Relapsed/Refractory Pediatric High-Grade Glioma Patients Showed Extended Progression Free Survival and Overall Survival FLORHAM PARK, N.J., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of drugs for the treatment of cancer, today announced the U.S. Food...Read more
REDWOOD CITY, Calif., Oct. 27, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to daraxonrasib, the company’s RAS(ON) multi-selective inhibitor, for the treatment of pancreatic cancer. “We are gratified the FDA...Read more
Adding WINREVAIR to background PAH therapy improved exercise capacity and WHO functional class (FC), and reduced the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death ZENITH data add to growing body of evidence supporting a positive benefit risk profile of WINREVAIR in a broad range of adult patients with PAH RAHWAY, N.J. / Oct 27, 2025 / Business Wire / Merck (NYSE: MRK), known as...Read more
First and only therapy FDA approved in both R/R acute myeloid leukemia (AML) with an NPM1 mutation and R/R acute leukemia with a KMT2A translocation Second approved indication for Revuforj in less than one year further solidifies Syndax’s leadership in menin inhibition Included in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for R/R NPM1 mutated AML Syndax to host conference call today at 2:30 p.m. ET NEW YORK,...Read more
This approval is supported by data from the Phase III OASIS clinical trial program evaluating Lynkuet for the treatment of moderate to severe hot flashes due to menopause1 In OASIS 1 and OASIS 2, Lynkuet met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline1 Hot flashes are a common symptom of menopause2 and one of the main reasons women seek...Read more
EUA to Treat Dogs for NWS Issued Prior to Fly Being Detected in the U.S.; Action Prepares Veterinarians and Pet Owners with Treatment Options First FDA emergency use authorization (EUA) ever granted for NWS in dogs Action reinforces agency's commitment to providing treatment options for NWS in advance of the fly being detected in the U.S. Published literature showed Credelio may be effective in treating NWS in dogsi Preventing open...Read more
Significant unmet need for patients requires new and novel treatments1 DREAMM-7 showed a 51% reduction in the risk of death and tripled median progression-free survival in 3L+ indicated population versus a daratumumab-based triplet2 Blenrep is the only anti-BCMA accessible in the community setting where 70% of patients receive care, and with a new streamlined REMS program3 Robust clinical development is ongoing to advance Blenrep in...Read more
Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the risk of death by 50% and increased pathologic complete response rates by 48% compared with surgery alone If approved, these would be the first and only perioperative regimens to have improved survival in this patient population RAHWAY, N.J. / Oct 23, 2025 / Business Wire / Merck (NYSE: MRK), known as MSD outside...Read more
Upon Approval of NDA Quoin Will Receive Seven Years Marketing Exclusivity for QRX003 in the US Orphan Drug Designation previously granted by the European Medicines Agency in May 2025 ASHBURN, Va., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (“Quoin” or the “Company”), a late clinical-stage specialty pharmaceutical company focused on rare and orphan diseases, today announced that the U.S. Food...Read more
BRISBANE, Calif., Oct. 21, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients today reported it has received a Paragraph IV Certification Notice Letter (PIV Notice) from The WhiteOak Group, a subsidiary of a small private Chinese company. WhiteOak has filed an Abbreviated New Drug Application, or ANDA,...Read more
Clearance expands Company's competitive advantage of clinically proven, minimally invasive technologies to treat debilitating SI joint conditions from multiple surgical approaches SImmetry+'s New 3D printed titanium implants, robust joint decorticator, and simple bone graft delivery system provides physicians treatment options rooted in established fusion principles Company initiating alpha launch of SImmetry® + with select group of...Read more
>80% KIT knock-down and significant tumor-volume reduction in systemic mastocytosis and GIST models; GLP-validated bio analytics complete; Japan Patent protects through 2039 as IND work advances. Planned Next Steps (Near-Term): Complete GLP toxicology and CMC packages; submit IND. Initiate Phase 1/2 dose-escalation/expansion study in advanced systemic mastocytosis and other KIT-driven tumors with translational biomarkers...Read more
Detailed results from bezuclastinib’s positive SUMMIT trial evaluating bezuclastinib in patients with NonAdvanced Systemic Mastocytosis planned for presentation at upcoming scientific conference this year NDA submission for bezuclastinib planned by YE 2025 WALTHAM, Mass. and BOULDER, Colo., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision...Read more
Designation highlights GeneDx innovation in clinical whole genome and whole exome testing and accelerates the pathway for FDA authorization of these novel diagnostic tests GAITHERSBURG, Md. / Oct 20, 2025 / Business Wire / GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its...Read more
Chimerix is on a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. The company is devoted to filling gaps in the treatment paradigm. Chimerix’s most advanced clinical-stage program is in development for H3 K27M-mutant glioma....
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