– Completion of BLA submission expected in Q4 2026 – Sept. 21, 2026 -- PTC Therapeutics, Inc., (NASDAQ: PTCT) today announced that it completed the previously announced agreement with Sangamo Therapeutics, Inc. to acquire ST-920 – a BLA-stage, one-time administered AAV gene therapy for Fabry disease. A rolling BLA submission to FDA for accelerated approval of ST-920 is expected to be completed in Q4 2026. "Our team looks forward to completing the ST-920 BLA submission and potentially bringing

Iambic launched a larger version of its Enchant drug-discovery model on Monday alongside a multi-year agreement with AbbVie that will put the technology to work across immunology, neuroscience and oncology. The tie-up adds another large pharma partner to Iambic's portfolio just months after deals with Takeda and Bayer. "The goal of our collaboration with Iambic is to design better molecules more efficiently and improve our probability of success, ultimately to deliver breakthrough medicines for

NIH-supported research will evaluate the mechanistic effects of fosamprenavir and support a Phase II randomized, double-blind, placebo-controlled clinical trial in patients with PPI-refractory GERD N-Zyme Biomedical Inc. (“N-Zyme”), a clinical-stage biotechnology company developing novel pepsin-targeted therapies for reflux disease, today announced that a research team led by N-Zyme Co-Founder and Chief Scientific Officer Dr. Nikki Johnston has been awarded US$2.76 million through an R01 resear

Round Led by .406 Ventures Fuels Teal Health's Next Phase of Growth, Expanding Payor, Health System, Employer and Provider Partnerships Ahead of Broad Insurance Coverage in 2027 Sept. 22, 2026 -- Teal Health, creators of the Teal Wand™, the first and most accurate FDA-authorized self-collection device for at-home HPV cervical cancer screening, today announced $22 million in Series A funding to meet accelerating consumer demand and expand access ahead of broad insurance coverage beginning in Ja

- First-in-Class approval supported by Phase 3 BROADWAY, BROOKLYN, and TANDEM trials demonstrating significant LDL-C reductions with favorable tolerability profile- - First global regulatory approval of obicetrapib marks a defining milestone for NewAmsterdam and Menarini, expanding treatment options for patients with elevated LDL-C - Sept. 21, 2026 -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), a late-stage, clinical biopharmaceutical company developing

KEYTRUDA QLEX is the first and only subcutaneous immune checkpoint inhibitor in Japan that can be administered by a healthcare provider in as little as one minute Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous use for all indications approved in Japan for KEYTRUDA® (pembrolizumab), Merck’s anti-

— ALKS 7290 is the First Orexin 2 Receptor Agonist to Demonstrate Clinically Meaningful Improvements in ADHD Symptoms in Adults — — ALKS 7290 Was Generally Well Tolerated at All Doses Tested in Healthy Volunteers and Adults With ADHD — — Phase 2 Study of ALKS 7290 in Adults With ADHD is Enrolling, Data Expected in 2027 — Alkermes plc (Nasdaq: ALKS) today announced positive topline results from a phase 1 proof-of-concept study evaluating ALKS 7290, the company’s novel, investigational orexin 2

New ready-to-use fluorescent imaging agent eliminates reconstitution at the point of care, giving surgical and imaging teams a differentiated option for fluorescence-guided procedures Sept. 22, 2026 -- Sagent Pharmaceuticals ("Sagent"), a leading provider of generic and specialty pharmaceuticals, today announced that Zyogreen® (indocyanine green injection), the first and only FDA-approved ready-to-use (RTU) indocyanine green (ICG) injection in the United States, is now commercially available. T

Feedback from U.S. FDA supports advancement into Phase 2 STRIDE-MDS trial in patients with R/R HR-MDS First-in-class, mutation-agnostic approach has the potential to address a broad R/R HR-MDS population PureTech intends to secure external capital in the first half of 2027 to support the continued development of LYT-200 through its Founded Entity, Gallop Oncology PureTech Health plc (LSE: PRTC) ("PureTech" or the "Company"), a hub-and-spoke biotherapeutics company dedicated to giving life to sc

Primary endpoint and the key secondary endpoint were met with high statistical significance and CUE-221 demonstrated an overall favorable safety profile Clinically different efficacy profile observed relative to XOLAIR® (omalizumab) highlights potential for a fundamental mechanism-based biological difference Cue Biopharma to host conference call on Monday, September 21, at 8:00 a.m. EDT Sept. 20, 2026 -- Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company targeting transfo