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
Epioxa Provides the Ophthalmic Community and Patients with the First and Only FDA-Approved, Incision-Free, Topical Drug Therapy for Keratoconus Epioxa Represents a Novel, Groundbreaking Therapy for Patients Afflicted by This Sight-Threatening Rare Disease Epioxa Expected to Be Commercially Available in Q1 2026 ALISO VIEJO, Calif. / Oct 20, 2025 / Business Wire / Glaukos Corporation (NYSE: GKOS), an ophthalmic pharmaceutical and...Read more
Prescription Drug User Fee Act (PDUFA) target action date set for April 10, 2026 WOBURN, Mass., Oct. 20, 2025 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Biologics License Application (BLA) for RP1 in combination with...Read more
FDA approval based on superiority of Gazyva over standard therapy alone, as shown in Phase II NOBILITY and Phase III REGENCY data Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomized Phase III study Lupus nephritis affects more than 1.7 million people worldwide, predominantly women of color and childbearing age, with up to one third of patients...Read more
Final FDA Type C Meeting December 11, 2025 - biomarker data to be available October 10, 2025 FDA/Osteosarcoma Institute Workshop narrows focus for OST-HER2 overall survival, biomarker correlation & canine osteosarcoma data New York, New York--(Newsfile Corp. - October 17, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or "the Company"), a clinical-stage cancer immunotherapy and antibody drug conjugate...Read more
BiomX believes that it has fully addressed the FDA’s queries related to the third-party nebulizer used to deliver BX004, which are narrow in scope; an additional FDA request for limited technical clarifications on the nebulizer has also been addressed In parallel, new written FDA feedback underscores the significant unmet need BiomX is addressing and outlines new potential development approaches European enrollment and dosing remain...Read more
LONDON, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals International, plc (Nasdaq: KNSA) (Kiniksa), a biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications, today announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to KPL-387 for the treatment of pericarditis, which includes recurrent pericarditis....Read more
Potential First-in-Class Treatment for Nicotine E-cigarette or Vaping Cessation Receives Unprecedented Expedited Review Pathway One of Only Nine Therapies Chosen for the FDA’s Inaugural National Priority Voucher Program SEATTLE and VANCOUVER, British Columbia, Oct. 17, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and...Read more
REDWOOD CITY, Calif., Oct. 16, 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 a non-transferrable voucher for daraxonrasib (RMC-6236), the company’s RAS(ON) multi-selective inhibitor, under the Commissioner's National Priority Voucher...Read more
Disc is seeking accelerated approval of bitopertin for patients aged 12 years and older with EPP The CNPV program is designed to reduce the drug application review process to 1-2 months WATERTOWN, Mass., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Disc Medicine, Inc. (NASDAQ:IRON), a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel treatments for patients suffering from serious...Read more
Breakthrough Therapy designation recognizes the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with treatment-resistant depression FDA designation follows previously announced Phase 2b topline data which showed rapid and durable antidepressant outcomes following a single dose of BPL-003 Breakthrough Therapy designation provides intensive FDA guidance to support advancement of...Read more
Prioritization of refractory rheumatoid arthritis (RA) as lead indication for AlloNK® development FDA Fast Track Designation received for AlloNK in refractory RA, representing the first drug candidate in the deep B-cell depleting category to receive this designation with the potential to become the first in the category to advance to a pivotal trial in RA, pending FDA feedback expected in 1H 2026 Continued execution and...Read more
ST. LOUIS, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE Mark in Europe and submitted a 510(k) application to the FDA in the US for the Synchrony™ system. Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony’s slim and stunning 55” 4K ultra-high-definition...Read more
Once-daily Precision Timed Release™ (PTR™) stimulant designed to deliver rapid onset of effect and entire active-day duration NDA accepted under the FDA’s 505(b)(2) regulatory pathway KANSAS CITY, Kan., Oct. 14, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING) a biopharmaceutical company developing and advancing a pipeline of next-generation pharmaceutical products utilizing its proprietary Precision Timed Release™...Read more
PITTSBURGH, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) announced today that the United States Food and Drug Administration (FDA) granted platform technology designation to the genetically modified, non-replicating herpes simplex virus type 1 (HSV-1) viral vector used in the Company’s redosable eye drop gene therapy KB801, currently under evaluation in a randomized placebo controlled trial for...Read more
Prescription Drug User Fee Act (PDUFA) target action date is March 28, 2026 All primary and secondary endpoints were met, and KRESLADI™ was well tolerated Rocket is eligible for a Rare Pediatric Disease Priority Review Voucher, should KRESLADI™ be approved CRANBURY, N.J. / Oct 14, 2025 / Business Wire / Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a fully integrated, late-stage biotechnology company advancing a sustainable pipeline...Read more
SOUTH SAN FRANCISCO, Calif., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Denali Therapeutics Inc. (Nasdaq: DNLI) today announced that the U.S. Food and Drug Administration (FDA) has extended its review timeline of the Biologics License Application (BLA) seeking accelerated approval of tividenofusp alfa for the treatment of mucopolysaccharidosis type II (MPS II), also known as Hunter syndrome. The Prescription Drug User Fee Act (PDUFA) target date...Read more
Updated indication allows the use of RINVOQ® (upadacitinib) prior to the use of tumor necrosis factor (TNF) blocking agents in patients for whom use of these treatments is clinically inadvisable and who have received at least one approved systemic therapy NORTH CHICAGO, Ill., Oct. 13, 2025 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the U.S. Food and Drug Administration (FDA) approval of a supplemental new drug...Read more
Rules out Alzheimer's pathology in early stages to enhance diagnostic pathway efficiency Provides new opportunity to broaden access and improve referral quality Features as part of Roche's growing portfolio designed to further shape Alzheimer's diagnostic pathways INDIANAPOLIS, Oct. 13, 2025 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (FDA) has cleared...Read more
SAN DIEGO, Oct. 13, 2025 /PRNewswire/ -- Avidity Biosciences, Inc. (Nasdaq: RNA), a biopharmaceutical company committed to delivering a new class of RNA therapeutics called Antibody Oligonucleotide Conjugates (AOCs™) to profoundly improve people's lives, today announced that the Company completed a positive pre-BLA meeting with the U.S. Food and Drug Administration (FDA) regarding its upcoming BLA submission of delpacibart zotadirsen...Read more
If approved, it would be the first needle-free insulin option for pediatric patients in 100+ years of insulin therapy sBLA submission based on data from the Phase 3 INHALE-1 study PDUFA target action date of May 29, 2026 WESTLAKE VILLAGE, Calif. and DANBURY, Conn., Oct. 13, 2025 (GLOBE NEWSWIRE) -- MannKind Corporation (Nasdaq: MNKD) today announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental...Read more
Initiated Nationwide Commercial Launch of AYON in September The Company is Hosting a Virtual Key Opinion Leader Event to Discuss the Commercial Launch of AYON on October 14, 2025 CLEARWATER, Fla., Oct. 13, 2025 (GLOBE NEWSWIRE) -- Apyx Medical Corporation (NASDAQ: APYX) (“Apyx Medical” or the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency platform technology marketed and sold as Renuvion® and the AYON...Read more
Confirmation of 30mg efti as optimal biological dose relevant for Immutep’s oncology pipeline and potential future Biological License Applications (BLA) Registrational TACTI-004 (KEYNOTE-F91) Phase III trial in first line non-small cell lung cancer now in process of opening clinical sites in the United States SYDNEY, AUSTRALIA, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a...Read more
Designation supported by results from multiple dose cohorts from the Phase 1/1b trial of ficerafusp alfa in 1L HPV-negative R/M HNSCC BOSTON, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has granted...Read more
RDEA Pilot Program provides sponsors enhanced communication and collaboration with FDA to accelerate development of rare disease therapies CLEVELAND, Oct. 13, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a commercial-stage biopharmaceutical company developing cell and gene therapies for serious diseases, today announced that its ABO-503 gene therapy for X-linked retinoschisis (XLRS) has been selected to...Read more
FDA approves UZEDY® (risperidone) extended-release injectable suspension for subcutaneous use as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults.1 UZEDY (risperidone) extended-release injectable suspension for subcutaneous use is indicated for use every one or two months for the treatment of schizophrenia in adults.1 This approval marks a significant step...Read more
Breakthrough Therapy designation comes in addition to previously awarded Fast Track designation SAN DIEGO, Oct. 09, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for...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...
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