Based on VOLGA Phase III trial results which demonstrated statistically significant and clinically meaningful improvements in event-free survival and overall survival AstraZeneca’s supplemental Biologics License Application (sBLA) for IMFINZI ® (durvalumab) in combination with enfortumab vedotin (EV) has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy

The FDA has greenlit Elevar Therapeutics' Lyrfigtu (lirafugratinib) for adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma harbouring an FGFR2 gene fusion or other rearrangement. The approval covers patients who have received prior chemotherapy or chemoimmunotherapy and who have not previously been treated with an FGFR inhibitor. The filing was supported by Phase I/II data from the ReFocus trial involving a cohort of 116 patients with unresectable o

Sept. 25, 2026 -- Kodiak Sciences Inc. (Nasdaq: KOD), a precommercial retina-focused biotechnology company committed to researching, developing and commercializing transformative therapeutics, today announced that the company will report topline results from DAYBREAK, a Phase 3 study evaluating both Zenkuda TM (tarcocimab tedromer) and KSI-501 (tabirafusp alfa tedromer) for the treatment of patients with wet age-related macular degeneration, on Monday, September 28, 2026. Kodiak Sciences (Nasdaq

FDA approval supported by data from BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe alopecia areata (AA) Treatment with Olumiant resulted in substantial scalp hair regrowth, as well as improvements in eyebrows and eyelashes Severe AA can result in extensive hair loss during adolescence, a formative stage of life Sept. 25, 2026 -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA)

Primary Endpoint Achieved in CBL-0202DD Phase 2 Trial—CBL-514 delivered statistically significant pain reduction across both FAS and PP populations compared with placebo. Expansion Opportunity Beyond Dercum's Disease—Study findings support the potential development of CBL-514 for Lipedema, a condition affecting approximately 10% of women globally and representing a market opportunity of more than US$30 billion. Sept. 22, 2026 -- Caliway Biopharmaceuticals (TWSE: 6919) on September 21 announced

MAIA Biotechnology Expands Pivotal Phase 3 THIO-104 Non-Small Cell Lung Cancer Trial into Spain and Portugal THIO-104 advances toward key 2027 interim survival analysis Sept. 23, 2026 -- MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing immunotherapies for cancer, today announced that it has received regulatory approval by the Spanish Agency for Medicines and Medical Devices (AEMPS) and Portugal’s National A

SK pharmteco and GEMMABio Expand Rare Disease Manufacturing Collaboration Following Important Spinal Muscular Atrophy (SMA) Clinical Trial Milestone First patient dosed marks an important step for the SMA community and highlights a growing rare disease manufacturing partnership, with future GEMMABio programs expected to leverage SK pharmteco’s SKyvec™ viral vector platform Sept. 22, 2026 -- SK pharmteco announced today it has been working with Gemma Biotherapeutics (“GEMMABio”), a clinical-sta

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.

- 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-