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Drug Approvals News 11 October 2025 - 17 November 2025

Tonix Pharmaceuticals (TNXP) Jumps as TONMYA, First New Fibromyalgia Drug in 15 Years, Hits U.S. Pharmacies – November 17, 2025

Tonix Pharmaceuticals (TNXP) Jumps as TONMYA, First New Fibromyalgia Drug in 15 Years, Hits U.S. Pharmacies – November 17, 2025

Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) moved sharply higher today after the company confirmed that TONMYA™ (cyclobenzaprine HCl sublingual tablets), its newly approved fibromyalgia treatment, is now commercially available by prescription across the United States. GlobeNewswire+1 TONMYA Officially Launches in the U.S. Tonix announced at 7:00 a.m. EST that TONMYA is available for pharmacy ordering nationwide and can now be prescribed for adults with fibromyalgia. GlobeNewswire The drug is: TONMYA became the first new FDA‑approved therapy for fibromyalgia in more than 15 years when regulators cleared it on August 15, 2025, based on two pivotal Phase 3 trials involving nearly
17 November 2025
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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
13 November 2025
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Merck (MRK) Stock Could Skyrocket: Key Drug Approvals & Analyst Targets Unveiled

Merck (MRK) Stock Could Skyrocket: Key Drug Approvals & Analyst Targets Unveiled

Metric Merck (MRK) Last Price (10/10/25) $86.02 marketbeat.com Market Cap $215B marketbeat.com P/E (TTM) ~13× marketbeat.com Yield 3.8% marketbeat.com 52-Week Range $73.31 – $111.58 marketbeat.com YTD Total Return -11.07% financecharts.com Q2 2025 Sales $15.8B investing.com 2024 Sales $64.2B merck.com 2024 R&D Spend $17.9B merck.com Analyst PT (avg) $104 (12-mo) marketbeat.com Consensus Rating Hold marketbeat.com Company Overview Merck & Co. (MRK, called MSD outside North America) is a global healthcare company (75,000 employees merck.com) organized in Pharmaceuticals, Vaccines and Animal Health. It focuses on oncology/immunology, infectious disease (including vaccines), cardio-metabolic, and hospital specialty medicines merck.com. Its blockbuster product KEYTRUDA® (pembrolizumab) – a PD-1 checkpoint
11 October 2025
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