FDA says NDA and ANDA sponsors who submitted study data developed by Indias Panexcell Clinical Lab or Synchron Research Services must repeat the studi...
Johnson & Johnson reports new data showing increased protection against Covid-19 when a booster shot of its vaccine is administered.
FDA warns the Fibromyalgia Treatment Group it is selling unapproved new drugs.
FDA posts a draft guidance entitled Questions and Answers on Quality-Related Controlled Correspondence for generic drug developers.
Medtronics Micro Therapeutics unit recalls its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology due to t...
Pfizer and BioNTech announce results from a Phase 2/3 trial showing a favorable safety profile and robust neutralizing antibody responses for a lower-...
FDA sends Verrica Pharmaceuticals a complete response letter on its NDA for VP-102 for treating the skin disease molluscum contagiosum.
FDA approves a Samsung Bioepis and Biogen BLA for Byooviz (ranibizumab-nuna), the first biosimilar version of Genentechs age-related macular degenerat...