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-

— 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