FDA warns Malaysias BioAsia Worldwide about CGMP violations in its production of finished drugs, some of which may be regulated as cosmetics.
Cytokinetics reports topline results from its Phase 3 MAPLE-HCM clinical trial showing that aficamten significantly improved exercise capacity in pati...
FDA accepts for priority review a Regenxbio BLA seeking accelerated approval for gene therapy RGX-121 (clemidsogene lanparvovec) for treating Hunter s...
FDA sends Indian active pharmaceutical ingredient manufacturer Mentha & Allied Products a Warning Letter that cites the firm for significant GMP viola...
FDA and HHS ask public stakeholders for their ideas on regulations that should be eliminated.
FDA warns Frances Excelvision Fareva about CGMP violations in its production of finished drugs.
FDA plans to remove from the market concentrated ingestible fluoride prescription drug products for children, citing safety concerns and a lack of for...
Assertio Therapeutics agrees to pay $3.6 million to resolve claims that it violated the False Claims Act by causing the submission of false claims abo...
