FDA updates granola bar recall
The MAGA meltdown after Tom Hanks played a racist Trump fan on Saturday Night Live’s 50th anniversary show now includes a ...
Innate Pharma and Merus gets FDA Breakthrough Therapy Designation for their respective treatments
Innate Pharma SA (IPHA) announced that the FDA has granted Breakthrough Therapy Designation to lacutamab for treating adults ...
FDA approves tablet form of Evrysdi for spinal muscular atrophy
The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...
Managed Healthcare Executive14h
FDA Accepts Alvotech/Teva’s Application for Eylea Biosimilar
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval ...
Chimerix’s NDA for dordaviprone accepted by FDA
Chimerix (CMRX) announced the FDA has accepted its New Drug Application, or NDA, seeking accelerated approval for dordaviprone as a treatment ...