A strict new vaccine approval process in the U.S. could dramatically slow things down for biopharma and the public, experts ...
This effort to accelerate development can be clearly seen in how the agency is approaching biosimilars. In October 2025, the FDA issued a guidance update indicating that “switching” studies — a trial ...
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 ...
Discover the EMA's role in promoting safe medicine access in the EU. Learn about its responsibilities in drug evaluation, ...
It took 27 years, but Cytokinetics secured its first U.S. drug approval. On Friday, the Food and Drug Administration cleared ...
The FDA approved nerandomilast tablets for adults with progressive pulmonary fibrosis, according to an industry press release ...
The FDA today approved nerandomilast (Jascayd; Boehringer Ingelheim) for the treatment of progressive pulmonary fibrosis (PPF ...
The agency’s high-level turnover and conflicting policy decisions on drug oversight have fueled concerns about the leadership ...
Formaldehyde is a common chemical used in various industries as a disinfectant, resin precursor, and synthetic intermediate.
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