Designation enhances Kedrion's development program for QIVIGY® and represents an important milestone for patients with Stiff Person Syndrome Sept. 22, 2026 -- Kedrion Biopharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Immune globulin intravenous, human 10% solution (tradename QIVIGY®) for the treatment of Stiff Person Syndrome (SPS), a rare and often disabling neurological disorder estimated to affect approximately two per 100,000 people.

Envisagenics’ platform makes use of AI to screen and detect cancer-specific RNA alterations, which Boehringer Ingelheim wants to target through various precision treatment modalities, including multi-specific antibodies, antibody-drug conjugates and T cell engagers. Boehringer Ingelheim is partnering with Envisagenics to leverage the biotech’s AI-forward approach to RNA splicing—a particular molecular alteration in cancer that the companies claim is “one of the last largely untapped sources” of

The medtech rumor mill is churning with speculation that GE HealthCare may be in M&A talks with Sofie Biosciences. Citing “people familiar with the matter,” the Financial Times reported that GE HealthCare could pay up to $1 billion for Sofie. Dulles, VA-based Sofie Biosciences develops and delivers molecular diagnostics and therapeutics (theranostics). During Wells Fargo’s annual healthcare conference last week, GE HealthCare CEO Peter Arduini said the company believes there are "some good oppor

– 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