Omeros to Host Conference Call Monday, December 29, 2025 at 4:30 p.m. ET First and only approved option: YARTEMLEA® is the only approved treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) and is indicated for adults and children ages two years and older. High complete response (CR) rates: YARTEMLEA-treated patients achieved CR rates of 61% in the pivotal trial and 68% in the Expanded...Read more
PORTLAND, Maine, Dec. 24, 2025 (GLOBE NEWSWIRE) -- ImmuCell Corporation (Nasdaq: ICCC) (“ImmuCell”), an animal health company that develops, manufactures and markets products that improve cattle health and productivity today announced that it received an Incomplete Letter from the United States Food and Drug Administration (FDA) on December 23, 2025 for its Re-Tain® New Animal Drug Application (NADA), and simultaneously that it is...Read more
AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Marketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S. brand name for PK deficiency indication AQVESME expected to be available in late January 2026, following AQVESME REMS program implementation Company will host investor conference...Read more
Initial modules submitted to FDA under rolling review; final modules expected in the first half of 2026 CANTON, Mass., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the initiation of a rolling...Read more
IRVINE, Calif. / Dec 23, 2025 / Business Wire / Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system is indicated for the treatment of symptomatic...Read more
Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the treatment of schizophrenia Current data package highlights long-term safety profile, broad-spectrum clinical activity, and favorable adherence observed to date for once daily brilaroxazine over up to one year Initiation of RECOVER-2...Read more
NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition...Read more
Approvals expand Amneal’s biosimilars portfolio Company expects to commercialize six biosimilars across eight presentations by 2027 BRIDGEWATER, N.J., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved its...Read more
Abbott's Volt™ PFA System, the latest generation of cardiac ablation technology, is designed for people battling heart rhythm disorders such as atrial fibrillation (AFib) Pulsed field ablation – or PFA – is a minimally invasive procedure that uses high-energy electrical pulses in targeted areas of the heart to treat irregular heart rhythms Abbott's Volt PFA System is an all-in-one product that is clinically proven to simplify the...Read more
The BLA was Resubmitted with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Priority Review was Requested LANGHORNE, Pa. / Dec 22, 2025 / Business Wire / Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced today that it has resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer. The...Read more
PDUFA target action date of June 30, 2026 Priority Review designation is granted to applications for drugs that, if approved, would be a significant improvement in the safety or effectiveness of treating a serious condition Veligrotug now has both Priority Review and Breakthrough Therapy Designations, each following requests which included data on veligrotug’s (i) consistent and robust improvement and resolution of diplopia...Read more
Tenth Breakthrough Therapy Designation for AstraZeneca and Daiichi Sankyo’s ENHERTU with the latest based on DESTINY-Breast05 Phase III trial results WILMINGTON, Del. / Dec 22, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been granted Breakthrough Therapy Designation (BTD) in the US for adult patients with HER2-positive early breast cancer with residual invasive disease in the...Read more
Lunsumio VELO reduces administration time from 2-4 hours to approximately one minute – Availability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences – Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse – SOUTH SAN FRANCISCO, Calif. / Dec 22, 2025 / Business Wire /...Read more
MYQORZO, a Cardiac Myosin Inhibitor, Directly Addresses Underlying Hypercontractility Associated with Obstructive HCM FDA Approval Based on Results of SEQUOIA-HCM MYQORZO is Company’s First FDA-Approved Medicine Company to Host Investor Conference Call Today at 4:30 PM Eastern Time SOUTH SAN FRANCISCO, Calif., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) today announced that the U.S. Food and Drug...Read more
The PL-16 Viral Blocker has shown over 90% success in protection of cells against viruses Raanana, Israel, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Polyrizon Ltd., a pre-clinical-stage biotechnology company developing intranasal protective solutions, announced today that it has submitted a Pre-Request for Designation (Pre-RFD) to the U.S. Food and Drug Administration (FDA) for its PL-16 Viral Blocker, a non-pharmacological intranasal...Read more
NORCROSS, Ga., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of galectin-3-targeted therapeutics for patients with MASH cirrhosis and portal hypertension, today announced that the U.S. Food and Drug Administration (FDA) has provided a written response, and subsequent communications, to the Company’s previously submitted Type C meeting request regarding the development program for...Read more
CAMBRIDGE, Mass., Dec. 19, 2025 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a clinical-stage biopharmaceutical company focused on identifying and developing novel treatments for rare diseases and multi-drug resistant (MDR) bacterial infections, today announced that its development partner, GSK, filed a New Drug Application (NDA) resubmission to the U.S. Food and Drug Administration (FDA) for tebipenem HBr, an...Read more
-- Innovative single-device solution integrates proven FemVue and FemChec® technologies to support fallopian tube evaluation and improve workflow efficiency-- ATLANTA, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today it has received 510(k) clearance from the...Read more
First and only delivery system designed specifically for premature infants with a patent ductus arteriosus (PDA), a life-threatening opening in their heart New delivery system enables precise placement of Abbott's Amplatzer Piccolo Occluder in the tiniest babies A PDA requiring treatment is present in approximately 20% of premature infants1 ABBOTT PARK, Ill., Dec. 18, 2025 /PRNewswire/ -- Abbott (NYSE: ABT) today announced it has...Read more
MINNEAPOLIS / Dec 18, 2025 / Business Wire / DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for preeclampsia (PE), fetal growth restriction (FGR) and acute ischemic stroke (AIS), today announced completion of a productive in-person pre-IND meeting with the United States Food and Drug Administration (FDA) for a planned study evaluating DM199 in preeclampsia. Minutes from the...Read more
Conditional Approval Marks Elanco's Third New World Screwworm Treatment Option for Companion Animals, Providing Multiple Treatment Solutions Prior to Fly Being Detected in the U.S. FDA's Conditional Approval of Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first for companion animals against New World screwworm Action follows previous Emergency Use Authorizations granted by the...Read more
STAAR study demonstrated positive mean annualized estimated glomerular filtration rate (eGFR) slope at 52-weeks across all dosed patients in the study, which U.S. Food and Drug Administration (FDA) has agreed will serve as an endpoint to support accelerated approval pathway Isaralgagene civaparvovec continues to show favorable safety and tolerability profile Sangamo expects to complete Biological License Application (BLA)...Read more
TRUFILL n-BCA is now indicated for embolization of the middle meningeal artery (MMA) for the treatment of symptomatic subacute and Chronic Subdural Hematoma (cSDH) as an adjunct to surgery. Approval builds on a trusted solution in neurovascular embolization for over 25 years. IRVINE, Calif., Dec. 18, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) – Today, Johnson & Johnson MedTech, a leader in neurovascular care,...Read more
RYBREVANT FASPRO™ is approved across all indications of RYBREVANT® (amivantamab-vmjw) SAN DIEGO, Dec. 18, 2025 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) today announced that Johnson & Johnson has received approval from the U.S. Food and Drug Administration (FDA) for RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj), which is co-formulated with ENHANZE® for patients with epidermal growth factor...Read more
HAYWARD, Calif. / Dec 18, 2025 / Business Wire / Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to proceed with the initiation of its...Read more
Receives U.S. Food and Drug Administration (FDA) Approval for Generic Version of Sandostatin® LAR Depot (Octreotide Acetate for Injectable Suspension) U.S. FDA Accepts New Drug Application for Low Dose Estrogen Weekly Patch for Contraception U.S. FDA Clears Investigational New Drug Application for MR-146 in Neurotrophic Keratopathy Japan Pharmaceuticals and Medical Devices Agency Accepts Japanese New Drug Application Filing for...Read more
RYBREVANT FASPRO™, the first and only subcutaneous therapy for patients with EGFR-mutated NSCLC, reduces administration time from hours to minutes and significantly reduces administration-related reactions1-5 Approval builds on previously reported Phase 3 MARIPOSA data showing unmatched overall survival benefit of this chemotherapy-free regimen, projected to exceed four years6 HORSHAM, Pa., Dec. 17, 2025 /PRNewswire/ -- Johnson...Read more
Exdensur is the first and only ultra-long-acting biologic with twice-yearly dosing approved for patients with severe asthma with an eosinophilic phenotype Approval based on SWIFT trials showing significantly lower rate of annualized asthma exacerbations in patients receiving depemokimab versus placebo SWIFT data included reduction in exacerbations requiring hospitalization and/or emergency department visits with depemokimab An...Read more
Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s...Read more
LEXINGTON, Mass. / Dec 15, 2025 / Business Wire / Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for the reproxalap New Drug Application (NDA) for the treatment of dry eye...Read more
Based on DESTINY-Breast09 Phase III trial results that showed AstraZeneca and Daiichi Sankyo’s ENHERTU in combination with pertuzumab reduced the risk of disease progression or death by 44% vs. THP with a median progression-free survival of more than three years WILMINGTON, Del. / Dec 15, 2025 / Business Wire / AstraZeneca and Daiichi Sankyo’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab has been approved...Read more
Clinical Development Program Appropriate for Rolling BLA Submission Expected by the End of 2025 CANTON, Mass., Dec. 15, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced the successful completion of a...Read more
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) -- HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”), today announced it has submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance. The MyoVista wavECG...Read more
A new multi-direction DWI sequence, the latest Swoop® system software, and the first advancement in Hyperfine’s Optive AI™ software, delivers clearer, higher-quality images for stroke diagnosis, enhancing the value of the Swoop® system in acute neurological care. GUILFORD, Conn. / Dec 15, 2025 / Business Wire / Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first...Read more
New PDUFA Target Action Date of January 14, 2026 set by FDA MIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in...Read more
WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen...Read more
Company is on track to file the Phase 3 protocol in the fourth quarter of 2025 SAN FRANCISCO, Dec. 15, 2025 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted roxadustat Orphan Drug Designation for the treatment of myelodysplastic syndromes (MDS). “The Orphan Drug Designation granted to roxadustat for MDS...Read more
FDA confirmed that data from single-arm studies in rare diseases, such as in ultra-rare deadly pediatric cancer osteosarcoma, could support a Biologics Licensing Application (BLA) under Accelerated Approval Program pathway, as stated in FDA guidance documents FDA proposed confirmatory study design include additional osteosarcoma disease settings such as prevention of recurrence following primary tumor resection, where a randomized...Read more
RANCHO CUCAMONGA, CA / ACCESS Newswire / December 15, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for teriparatide injection, USP 560 mcg/2.24mL (250 mcg/mL) single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's...Read more
Expanded indication for AKEEGA® (niraparib and abiraterone acetate dual-action tablet) plus prednisone marks the first FDA-approved precision medicine combination treatment for patients with BRCA2-mutated mCSPC HORSHAM, Pa., Dec. 12, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for AKEEGA® (niraparib and...Read more
First FDA approved treatment in 30+ years for more than 2 million Americans with PSVT Novel nasal spray designed to rapidly resolve episodes of PSVT and restore sinus rhythm FDA approval in PSVT enables development of AFib-RVR under sNDA pathway Milestone well-capitalized to launch and commercialize CARDAMYST with existing capital and royalty financing Conference call and webcast December 15, 8:00 a.m. ET MONTREAL and...Read more
FDA approval was based on results from the largest Phase 3 clinical trial ever conducted for a new treatment against Neisseria gonorrhoeae infection in regions with a high prevalence of gonorrhea across five countries. NUZOLVENCE is one of the first new treatments approved by the FDA for uncomplicated urogenital gonorrhea in nearly two decades. Gonorrhea affects more than 82 million people worldwide each year and is the second...Read more
GAITHERSBURG, Md., Dec. 12, 2025 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE: EBS) today announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental Biologics License Application (sBLA) for its Winnipeg, Canada facility to be added as the drug product manufacturing and testing site for raxibacumab, a monoclonal antibody for the treatment and prophylaxis of inhalational anthrax. “We are pleased with the...Read more
DAYBUE STIX provides Rett syndrome patients and caregivers with new flexibility and choice in their treatment with DAYBUE DAYBUE and DAYBUE STIX are the only FDA-approved treatments for Rett syndrome, a rare neurodevelopmental disorder SAN DIEGO / Dec 12, 2025 / Business Wire / Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the U.S. Food and Drug Administration (FDA) has approved DAYBUE® STIX (trofinetide) for oral...Read more
UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing* First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMG THOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are...Read more
Designation expands (Z)-Endoxifen program into rare pediatric neuromuscular disease and may qualify Atossa for a future Priority Review Voucher upon approval SEATTLE, Dec. 11, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, today announced that the U.S. Food and...Read more
Fast Track designation supported by positive results from the KT-621 BroADen Phase 1b atopic dermatitis (AD) patient trial KT-621 BROADEN2 Phase 2b AD trial ongoing, with data expected to be reported by mid-2027 and BREADTH Phase 2b trial in asthma on track to initiate in 1Q26 WATERTOWN, Mass., Dec. 11, 2025 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing...Read more
The U.S. FDA assigned a target action date of April 8, 2026 PRINCETON, N.J. / Dec 11, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric (12 years and...Read more
FDA clearance expands da Vinci SP indications to include inguinal hernia repair, cholecystectomy, and appendectomy SUNNYVALE, Calif., Dec. 10, 2025 (GLOBE NEWSWIRE) -- Intuitive (NASDAQ: ISRG), a global technology leader in minimally invasive care and the pioneer of robotic-assisted surgery, today announced that the U.S. Food and Drug Administration (FDA) has cleared the da Vinci Single Port (SP) surgical system for use in inguinal...Read more
FDA Clearance Granted After Successful Appeal, Overturning Prior Not Substantially Equivalent (NSE) Outcome HeartBeam’s Credit-Card Sized Device Delivers Clinical-Grade Insights Directly to Patients Anytime, Anywhere Pivotal Milestone Unlocks Multiple Key Initiatives in Company’s Growth Strategy SANTA CLARA, Calif. / Dec 10, 2025 / Business Wire / HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming...Read more
Phase 1 dose escalation trial of monotherapy IDE574 expected to begin in 1Q 2026 Targeting to present preclinical data detailing pharmacologic profile and evidence of anti-tumor activity in solid tumor models at a medical conference in 1H 2026 SOUTH SAN FRANCISCO, Calif., Dec. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, announced the submission of an...Read more
Conditional approval extended through December 2026 for the treatment of CID in dogs CID confirmatory effectiveness trial expected to conclude in February 2026, ahead of FDA's June deadline - 51 dogs enrolled to date; ~49 more expected SAN FRANCISCO, CA / ACCESS Newswire / December 10, 2025 / Jaguar Health, Inc.(NASDAQ:JAGX) today announced that the U.S. Food and Drug Administration (FDA) has granted renewal of the...Read more
Clear recognition of high unmet need and urgency for the SCN2A community and plausibility of the mechanism of elsunersen FDA agreed to proposed changes to the EMBRAVE3 trial design to be a single-arm, baseline-controlled study Enrollment in EMBRAVE3 is quickly accelerating and topline results expected in 2026 Topline results from ongoing EMBRAVE study (Part A, n=9) expected in 1H 2026 BOSTON, Dec. 09, 2025 (GLOBE NEWSWIRE)...Read more
Expands Amneal’s injectables portfolio with an essential medicine used in hospitals for emergency and perioperative care BRIDGEWATER, N.J., Dec. 09, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s epinephrine injection USP, 1 mg/mL (1 mL), in single-dose vials and 1 mg/mL (30 mL) multi-dose...Read more
Olanzapine long-acting injectable (LAI) has the potential to offer the efficacy of olanzapine in a once-monthly, subcutaneous formulation, for a broad patient population1 Olanzapine LAI is designed to help support real-world adherence and improved stability, with the goal of addressing a critical treatment gap for people living with schizophrenia1 Teva is committed to advancing this innovative treatment option and further build on its...Read more
Novel technology paves the way for use of the company's industry-leading point-of-care electroencephalography (EEG) system to address long unmet need in delirium monitoring SUNNYVALE, Calif., Dec. 09, 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 that the U.S. Food...Read more
Placebo-controlled Phase 2 study will evaluate SAT-3247 treatment over three months among ambulatory children with Duchenne Study endpoints include safety and tolerability, effect on muscle force and function, and impact on muscle quality and regeneration Enrollment of first study participant anticipated by end of 2025 TORONTO / Dec 09, 2025 / Business Wire / Satellos Bioscience Inc. (TSX: MSCL, OTCQB: MSCLF) (“Satellos” or the...Read more
RMAT designation indicates that SENTI-202 has the potential to address unmet medical needs for patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) based on preliminary clinical evidence, and offers benefits of FDA working closely with Senti Bio to provide guidance and advice on generating the data needed to support approval of the product in an efficient manner Second FDA designation for SENTI-202 this year, after...Read more
Technology uses real-world sleep data and machine learning to help people with sleep apnea start and stay on therapy SAN DIEGO, Dec. 08, 2025 (GLOBE NEWSWIRE) -- Resmed (NYSE: RMD, ASX: RMD), the leading health technology company focused on sleep, breathing and care delivered in the home, today announced it has received U.S. Food and Drug Administration (FDA) clearance for Personalized Therapy Comfort Settings (PTCS), to be...Read more
Feedback from U.S. Food and Drug Administration (FDA) supports advancement into a pivotal Phase 3 trial and a 505(b)(2) regulatory pathway Phase 3 SURPASS-IPF trial remains on track to be initiated by PureTech’s Founded Entity, Celea Therapeutics, in the first half of 2026 BOSTON / Dec 08, 2025 / Business Wire / PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company...Read more
The Company plans to initiate a Phase 3 program evaluating INCA033989 in essential thrombocythemia (ET) patients with all types of CALR mutations in mid-2026, following alignment with regulators Updated safety and efficacy data for INCA033989 in ET, and new data in myelofibrosis (MF), will be presented at the upcoming 2025 ASH Annual Meeting WILMINGTON, Del. / Dec 07, 2025 / Business Wire / Incyte (Nasdaq:INCY) today announced that...Read more
U.S. FDA grants waiver of application fee for BLA Filing of OST-HER2 Scheduled pre-Marketing Authorisation Application meeting with United Kingdom's Medicines and Healthcare products Regulatory Agency on December 8, 2025 Scheduled Type C Meeting with United States Food & Drug Administration on December 11, 2025 New York, New York--(Newsfile Corp. - December 5, 2025) - OS Therapies Inc. (NYSE American: OSTX) ("OS Therapies" or...Read more
In the MZL cohort of TRANSCEND FL, Breyanzi delivered deep and durable responses in 95.5% of patients while demonstrating a consistent safety profile Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy PRINCETON, N.J. / Dec 04, 2025 / Business Wire / Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has...Read more
WASHINGTON, Dec. 4, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on protocol VP-VLY-686-3403, which until today limited the protocol to a maximum of 90 doses of tradipitant. The lift followed Vanda's formal dispute resolution request and an expedited re-review conducted by CDER leadership under the collaborative...Read more
Praxis confirms plans to submit the essential tremor NDA for ulixacaltamide in early 2026 BOSTON, Dec. 04, 2025 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today announced the successful completion of its...Read more
LEXINGTON, Mass. and AMSTERDAM, Dec. 04, 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 the company received final meeting minutes from the U.S. Food and Drug Administration (FDA) regarding a pre-Biologics License Application (BLA) meeting held on October 29, 2025 to discuss the application for AMT-130, an...Read more
New 100 mg/dL Target Glucose setting offers more customization and tighter glucose management. Enhanced algorithm helps users remain in Automated Mode to improve the user experience. Most requested new features enable healthcare providers to more effectively modify diabetes therapy to meet needs of people with diabetes. ACTON, Mass. / Dec 04, 2025 / Business Wire / Insulet Corporation (NASDAQ: PODD) (Insulet or the Company), the...Read more
ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (the “FDA”) has approved the Biologics License Application (“BLA”) for AVANCE® (acellular nerve allograft-arwx). Avance is an acellular nerve scaffold for the...Read more
Hugo RAS system brings choice to the U.S., coupled with the full suite of Medtronic surgical offerings, ultimately creating a connected and integrated operating room today and into the future. GALWAY, Ireland, Dec. 3, 2025 /PRNewswire/ -- Medtronic (NYSE: MDT), a global leader in surgical innovation, today announced the U.S. Food and Drug Administration (FDA) has cleared the Hugo™ robotic-assisted surgery (RAS) system for use in...Read more
Approval is based on results from the BRUIN CLL-321 trial, the only randomized Phase 3 study in CLL/SLL in which all patients were previously treated with a covalent BTK inhibitor This expanded indication represents a substantial increase in the number of CLL/SLL patients who may benefit from Jaypirca and aligns with the patient population endorsed by the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) INDIANAPOLIS,...Read more
NDA to be Submitted on a Rolling Basis, Beginning Early 2026 PETACH TIKVA, Israel, Dec. 03, 2025 (GLOBE NEWSWIRE) -- PolyPid Ltd. (Nasdaq: PYPD) (“PolyPid” or the “Company”), a late-stage biopharma company aiming to improve surgical outcomes, today announced that it has received a formal pre-New Drug Application (“NDA”) meeting minutes from the U.S. Food and Drug Administration (“FDA”) supporting the NDA submission of D-PLEX100, the...Read more
MELBOURNE, Australia and NEW YORK, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company developing innovative combination therapies, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for IHL-42X, the Company’s oral fixed-dose combination product candidate for the treatment of obstructive sleep apnea (OSA). The Fast Track...Read more
FDA feedback provides clear framework for Nexalin’s planned U.S. Pilot Study and supports a potential De Novo pathway for the Gen-2 SYNC™ device in Alzheimer’s disease HOUSTON, TX, Dec. 03, 2025 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (Nasdaq: NXL) (the “Company” or “Nexalin”), the leader in Deep Intracranial Frequency Stimulation (DIFS™) of the brain, today announced the successful completion of a substantive Q-Submission...Read more
Submission based on positive BaxHTN Phase III trial results which demonstrated statistically significant and clinically meaningful reduction in systolic blood pressure in patients with resistant or uncontrolled hypertension If approved, baxdrostat could be the first aldosterone synthase inhibitor to receive regulatory authorization WILMINGTON, Del. / Dec 02, 2025 / Business Wire / AstraZeneca’s New Drug Application (NDA) for...Read more
FDA approval marks Alpha Tau’s fifth simultaneous active U.S. IDE as the Company expands Alpha DaRT’s reach into recurrent prostate cancer JERUSALEM, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Alpha Tau Medical Ltd. (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT®, today announced that the FDA has approved an Investigational Device Exemption (IDE) application to initiate a pilot study for the...Read more
sNDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025 First Phase 3 PDT study in patients with sBCC in the United States submitted to FDA Primary and key secondary endpoints met with high statistical significance (p <0.0001) Favorable recurrence outcomes at one-year follow-up BCC is the most common skin cancer in the US with more than 3 million cases diagnosed...Read more
FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review. Assigned GDUFA goal date is July 29, 2026. NRx has applied to FDA for use of KETAFREE™ as a proprietary product name, which is subject to review. KETAFREE™ is the first preservative-free ketamine formulation that does not include potentially toxic preservatives used in current multidose presentations of...Read more
FDA lowers surveillance requirement to 50 patients from 300 patients in original HDE approval based on assessment of first 21 SAVE Surveillance Registry patients Compelling efficacy data to date along with completion of registry expected to expand QUELIMMUNE market opportunity DENVER, Dec. 02, 2025 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU), a commercial-stage healthcare company, announced today the...Read more
RICHMOND, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ST-503, an investigational epigenetic regulator for the treatment of intractable pain due to small fiber neuropathy (SFN), a type of chronic neuropathic pain. Fast Track Designation aims to facilitate the...Read more
Represents second complex respiratory therapeutic product approval in Q4 2025 BRIDGEWATER, N.J., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s albuterol sulfate inhalation aerosol (90 mcg per actuation). The product is the generic equivalent of PROAIR® HFA (albuterol sulfate...Read more
PASADENA, Calif. / Dec 02, 2025 / Business Wire / Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to investigational plozasiran as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (SHTG) (TG levels greater than or equal to 500 mg/dL). There are currently limited and inadequate...Read more
First and only investigational medicine for this rare, often fatal neurological condition On track to submit new drug application (NDA) in Q1 2026 CARLSBAD, Calif. / Dec 02, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to zilganersen for the treatment of Alexander disease (AxD), a rare,...Read more
Approval underscores Amneal’s advanced sterile manufacturing capabilities and expansion within complex ophthalmic therapies; Launch expected in Q1 2026 BRIDGEWATER, N.J., Dec. 01, 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 cyclosporine ophthalmic emulsion 0.05%, a sterile,...Read more
Centargo compatible with Ultravist® (iopromide), Isovue® (iopamidol), Optiray® (ioversol), Omnipaque™ (iohexol) and now, Visipaque™ (iodixanol) Follows recent FDA clearance to expand the use of compatible contrast agent presentations, adding single-dose vials in addition to Imaging Bulk Package presentations Radiology suites now have the ability to further manage contrast consumption and waste, while providing greater flexibility for...Read more
If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 seconds Would potentially provide a cost-effective and convenient option to address episodes of fluid buildup at home, benefiting patients, providers and payors PDUFA target action date of July 26, 2026 WESTLAKE VILLAGE, Calif. and BURLINGTON, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- MannKind...Read more
SGT-212 has been granted FDA Rare Pediatric Disease and Fast Track designations SGT-212 is the only dual route gene therapy in development to treat Friedreich’s ataxia FALCON Phase 1b clinical trial participant screening underway CHARLESTOWN, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Solid Biosciences Inc. (Nasdaq: SLDB) (the “Company” or “Solid”), a life sciences company developing precision genetic medicines for...Read more
On track to submit supplemental new drug application by end of year CARLSBAD, Calif. / Dec 01, 2025 / Business Wire / Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to olezarsen as an adjunct to diet to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (sHTG) (TG greater than or equal to 500 mg/dL)....Read more
Promising efficacy and favorable safety data from the Phase 1 study in heavily pre-treated patients show potential of CLN-049 to address a broad population of AML patients CAMBRIDGE, Mass., Dec. 01, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today announced that...Read more
B7H3 and PTK7 is co-expressed in multiple solid tumor types, including lung, colorectal, and head and neck cancers, at approximately 30%, 46%, and 27%, respectively Deep and durable regressions observed with IDE034 monotherapy in multiple preclinical in-vivo models with B7H3 and PTK7 co-expression Enhanced durability with IDE034 and IDE161 PARG inhibitor combination in preclinical in vivo models; targeting to share...Read more
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
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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