Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved TUKYSA® (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic human epidermal growth factor 2-positive (HER2+) breast cancer following induction treatment. The approval expands the use of TUKYSA to frontline, an earlier stage of metastatic disease, offering a new chemotherapy-free maintenance treatment

NIH-funded randomized, double-blind, placebo-controlled Phase 1 single-ascending-dose study expected to begin dosing healthy volunteers in November 2026 Preliminary topline data from initial cohorts anticipated in early 2027 Oct. 7, 2026 -- Dignify Therapeutics ("Dignify", the "Company"), a biopharmaceutical development company focused on restoring bowel and bladder control for people with neurological conditions, today announced that its Investigational New Drug (IND) application for DTI-117 h

GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, and the 15-20 National Hospital (l’Hôpital national des 15-20) in Paris today announced the publication of the results of the GS030 PIONEER trial in the prestigious medical journal The New England Journal of Medicine (NEJM). Available in the October 8, 2026

October 8, 2026 -- Addex Therapeutics (SIX: ADXN and Nasdaq: ADXN), a clinical-stage biopharmaceutical company focused on developing a portfolio of novel small molecule allosteric modulators for neurological disorders, today announced that its spin-out company, Neurosterix, in which Addex holds a 20% equity interest, has completed its Phase 1 clinical studies evaluating NTX-253 and plans to advance NTX-253 into Phase 2 clinical development. NTX-253 is a positive allosteric modulator (PAM) of the

Sept. 30, 2026 -- As population aging accelerates with demand for weight management continuing to expand, the market for GLP-1 receptor agonist (GLP-1RA) drugs is experiencing explosive growth. Tirzepatide, with annual sales of $36.507 billion in 2025, has become the latest Top Drug, underscoring the industry's momentum and commercial potential. To further advance long-acting and precise weight management, the industry has proposed a combination strategy using GIPR (glucose-dependent insulinotro

- Following its Parkinson's disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China. Sept. 29, 2026 -- iRegene Therapeutics Co., Ltd. ("iRegene" or the "Company"), a biotechnology company pioneering chemically induced allogeneic cell therapy, today announced that its investigational cell therapy NouvSight001 has received clearance from China's National Medical Products Administration (NMPA) for a Phase I/III clinical trial in patients

-Once-daily oral ALK2 inhibitor approved to reduce the volume of total new heterotopic ossification in patients aged 12 years and older with FOP -Atebrioz expected to be available in the United States in October through Mirum Access Plus (MAP), with eligible patients paying as little as $0 per month -PROGRESS pediatric development program continues to evaluate zilurgisertib in children aged 2 to <12 years Mirum Pharmaceuticals, Inc. (Nasdaq:MIRM) and Incyte (Nasdaq:INCY) today announced that

SLS009 increased apoptosis more than six-fold versus daraxonrasib in a MYC-amplified, daraxonrasib-resistant patient-derived pancreatic cancer organoid model - Combination of SLS009 and daraxonrasib further increased apoptosis to 36.5% and necrosis to 30.6%, supporting evaluation of CDK9 inhibition as a potential strategy to enhance RAS-directed therapy - SLS009 combined with BET inhibition demonstrated synergistic activity and sustained suppression of MYC, providing additional evidence of SLS0

- 48.9% placebo-adjusted reduction in psoriasis area and severity index (PASI) score achieved in mild-to-moderate plaque psoriasis patients with once-daily 200 mg 28-day treatment. - Steady-state elimination half-life after 28-day treatment in patients was 6.5 days, supporting potential once-weekly oral dosing. - Placebo-adjusted reduction in PASI score reached 65.9% in mild-to-moderate plaque psoriasis patients 15 days after last dose (28th dose), which supports potential once-weekly oral dosin

The FDA on Friday approved AbbVie's Juvmo (tavapadon) to treat adults with Parkinson's disease, according to a listing on the agency's approvals database. The pharma gained the D1/D5 partial agonist through its $8.7-billion takeout of Cerevel Therapeutics, announced in late 2023. However, the centrepiece of that deal, experimental schizophrenia treatment emraclidine, failed in mid-stage testing shortly after the acquisition closed (see – Spotlight On: Three things to watch at AbbVie). Despite