In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting ...

After receiving a complete response letter last week, the other shoe has dropped for Atara Biotherapeutics and its pipeline ...

The Philippine Coast Guard (PCG) has sacked its deputy commander in Masbate amid its ongoing probe as to how a vehicle ...

Despite receiving a prior wrist slap from the FDA in the shape of a Form 483, Sanofi is still working to right the ship at a ...

Abeona Therapeutics Inc.'s promising gene therapy for RDEB, potential FDA approval, undervalued stock, and key risks. Click ...

The US Food and Drug Administration hit two foreign seafood processors and one Buffalo, New York-based seafood importer with warning letters this week ...

after a post-marketing adverse drug experience (PADE) inspection. The PADE inspection of the New Jersey-based wholly-owned foreign subsidiary Laurus Generics Inc. included a comprehensive scrutiny ...

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some ...

Dr Reddy’s Laboratories reports 2% increase in net profit, attributing growth to new acquisitions and product launches.

The FDA issued a warning letter to Sanofi regarding significant manufacturing violations at its Genzyme Corporation Facility in Framingham, Mass. The letter, dated Dec. 16, 2024, and amended Jan. 15, ...

Cats — both large cats in captivity and pet house cats — across multiple states have been dying from H5N1 bird flu. Now, ...