Failure to act by the US Food and Drug Administration has increased the risk that criminals are operating in, and undermining, the drug regulatory process, Congress has been warned. Failure to act by ...
A strict new vaccine approval process in the U.S. could dramatically slow things down for biopharma and the public, experts ...
DUBLIN--(BUSINESS WIRE)--The "FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course" has been added to ResearchAndMarkets.com's offering. This seminar will provide a ...
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...
Dublin, Sept. 23, 2025 (GLOBE NEWSWIRE) -- The "FDA (Food and Drug Administration) Approval Process for Medical Devices Training Course (Dec 2nd-3rd, 2025)" has been added to ResearchAndMarkets.com's ...
Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.
The Wegovy pill's approval signifies a shift from injectable to oral dosage forms, driven by patient preference for ...
April 9, 2010 — In its latest effort to reduce the risks of medical radiation, the US Food and Drug Administration (FDA) yesterday notified manufacturers of radiotherapy equipment such as linear ...
In the wake of mass restructuring efforts across the Department of Health and Human Services (HHS), the FDA has missed yet another approval decision target date. GSK had expected to secure an FDA nod ...
The report says Biogen set an “unjustifiably high price” for Aduhelm to “make history” for the company, and thought of the drug as an “unprecedented financial opportunity.” Biogen priced Aduhelm at ...
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