September 7, 2020 –The U.S. FDA has approved GavretoTM (pralsetinib), manufactured by Roche, to treat
adults diagnosed with metastatic rearranged-during-transfection (RET) fusion-positive
September 1, 2020 –The U.S. FDA has approved the MiniMedTM 770G hybrid closed loop insulin pump
system, manufactured by Medtronic. According to the FDA, “it is the first legally marketed
August 31, 2020 – The U.S. FDA has approved Xaracoll® (bupivacaine HCl), an implant manufactured by
Innocoll Pharmaceuticals, to provide acute postsurgical pain relief for up to 24 hours
August 31, 2020 – Mylan and Biocon Biologics have launched SemgleeTM (insulin glargine injection) in vial
and pre-filled pen dosage forms. The product is FDA-approved to help control blood sugar
August 28, 2020 – The U.S. FDA has expanded its Emergency Use Authorization (EUA) for the investigational drug Veklury® (remdesivir), manufactured by Gilead. While not
August 28, 2020 – The U.S. FDA has approved Sogroya® (somapacitan-beco) injection 10mg/1.5mL
(6.7mg/mL), manufactured by Novo Nordisk, for the replacement of endogenous
August 27, 2020 – The U.S. FDA has approved Winlevi® (clascoterone cream 1%), manufactured by Cosmo Pharmaceuticals, to treat acne vulgaris in patients who are at least 12 years of age
August 27, 2020 – The U.S. FDA has approved an expanded indication for Ultravate® (halobetasol
propionate) topical lotion, manufactured by Sun Pharmaceuticals. The product can now