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NASDAQ:OTLK News 29 August 2025 - 13 November 2025

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (OTLK) Soars as FDA Accepts ONS‑5010 BLA and Sets December 31, 2025 Review Date

Outlook Therapeutics (NASDAQ: OTLK) shares jumped today after the U.S. FDA accepted the company’s resubmitted Biologics License Application (BLA) for ONS‑5010/LYTENAVA, its bevacizumab-based eye drug for wet AMD, and set a PDUFA review date of December 31, 2025. Here’s what investors need to know. What Outlook Therapeutics announced today This morning, Outlook Therapeutics, Inc. (NASDAQ: OTLK) announced that the U.S. Food and Drug Administration has accepted the company’s resubmitted Biologics License Application for ONS‑5010 (bevacizumab‑vikg)/LYTENAVA, its investigational ophthalmic formulation of bevacizumab for the treatment of wet age‑related macular degeneration (wet AMD). GlobeNewswire+2Outlook Therapeutics+2 According to the company’s press release and
COVID Booster Shocker, Pharma Mega-Deals & Alzheimer’s Breakthroughs – Global Health Roundup (Aug 28–29, 2025)

COVID Booster Shocker, Pharma Mega-Deals & Alzheimer’s Breakthroughs – Global Health Roundup (Aug 28–29, 2025)

Drug Approvals & Clinical Trial Results Updated COVID Boosters Get Narrow Nod: The U.S. FDA approved new fall COVID-19 booster shots from Pfizer/BioNTech and Moderna on August 27 – but with strict eligibility limits. Only adults 65+ and younger people with certain medical conditions are cleared for the updated vaccines, and emergency use authorizations for routine use in healthy children were removed realeconomy.rsmus.com. Health experts immediately sounded alarms: the Infectious Diseases Society of America blasted the “narrowed” booster rollout as contrary to scientific guidance and a risk to lives cidrap.umn.edu. They warn these restrictions could hinder access, especially for children,
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