6hon MSN
Legal questions swirl around FDA’s new expedited drug program, including who should sign off
FDA staffers and outside experts worry the program runs afoul of legal, ethical and scientific standards used to review new ...
13hon MSN
Takeaways from the AP’s report on turmoil surrounding the FDA’s new fast-track drug program
Questions remain among top Food and Drug Administration officials over who has the appropriate legal authority to sign off on ...
Loyal’s application for drug approval is another step closer to potential approval through the FDA Center for Veterinary ...
Optum notable drugs nearing FDA approval include Anaphylm, Sotyktu, and insulin icodec with decisions expected early 2026.
Since the U.S. prescription launch of NARCAN® Nasal Spray in 2016, the medicine has been trusted as a safe, effective way to reverse opioid ...
Takeda and Protagonist Therapeutics have submitted a new drug application to the FDA for rusfertide for adults with ...
NANJING, China and GAITHERSBURG, Md., Dec. 18, 2025 /PRNewswire/ -- TransThera Sciences Nanjing, Inc. (the "TransThera") announced that the new drug application for Tinengotinib tablets has been ...
A new study co-written by a University of Illinois Urbana-Champaign expert in operations management finds that drugs approved ...
GH Research plans to provide an update on the status of its investigational new drug application for GH001, a therapy for treatment-resistant depression. The biopharmaceutical company said Friday it ...
46 new molecular entities cleared the agency’s hurdles last year, 4 fewer than in 2024 ...
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