Discover how drugs prevent, cure, and alleviate ailments. Learn about over-the-counter vs. prescription drugs and the ...
Stockholm, Sweden, December 19, 2025. Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (NASDAQ Stockholm: EGTX), today announced that the Company has initiated a rolling New Drug Application ...
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 CNPV program significantly reduces drug review times, necessitating operational shifts for sponsors to meet compressed timelines. Sponsors must execute market access, pricing, and post-approval ...
Representatives of companies including AbbVie, Eli Lilly, Johnson & Johnson and Merck have voiced concerns about the FDA’s ...
Leaders at the U.S. Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental weight‑loss pill, after the company pushed for a faster ...
The agency is approaching the new overhaul as a chance to reshape drug regulations in the European Union.
The FDA is proposing to add bemotrizinol to the list of permitted active ingredients for use in sunscreens, according to a ...
Lilly was granted a voucher for its obesity pill, orforglipron, in November as part of a deal with the Trump ...
Researchers developed a blood test that spots ALS with 90% accuracy. The 46-gene panel could cut diagnostic delays that now ...
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