Pharmaceutical News and Articles

Comprehensive and up-to-date drug news for both consumers and healthcare professionals.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

CAMBRIDGE, MA ACCESS Newswire February 10, 2026 Moderna, Inc. (NASDAQ MRNA) today announced the U.S. Food and Drug Administration s (FDA) Center for Biologics E

NIH Halts Arm of Clinical Trial Evaluating a Potential Stroke Treatment

The National Institutes of Health (NIH) has stopped an investigational treatment arm of the Comparison of Anti-coagulation and Anti-platelet Therapies for Intra

FDA Approves Label Update for Kite’s Yescarta for Relapsed/Refractory Primary Central Nervous System Lymphoma

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1

Keytruda and Keytruda Qlex, Plus Paclitaxel ± Bevacizumab, Approved for Certain Adults with PD-L1+ (CPS ≥1) Platinum-Resistant Ovarian Carcinoma

PTC Therapeutics Provides Regulatory Update on Translarna

Disc Medicine Receives Complete Response Letter from FDA for Bitopertin for the Treatment of EPP

Harmony Biosciences Receives U.S. Food and Drug Administration Approval for Wakix (pitolisant) for the Treatment of Cataplexy in Pediatric Narcolepsy

Deciphera Pharmaceuticals Announces U.S. Food and Drug Administration Acceptance for Filing of New Drug Application for Tirabrutinib in Patients with Relapsed or Refractory PCNSL

FDA Approves Filkri (filgrastim-laha), a Biosimilar to Neupogen

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