June 4, 2021
June 4, 2021 – The U.S. FDA has approved Ryplazim® (plasminogen, human-tvmh), manufactured by
Liminal BioSciences, to treat plasminogen deficiency type 1 (hypoplasminogenemia)
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June 2, 2021
June 2, 2021 – The U.S. FDA has approved Brexafemme® (ibrexafungerp), manufactured by Scynexis, to
treat vulvovaginal candidiasis (VVC) in adult and postmenarchal
June 1, 2021
June 1, 2021 – The U.S. FDA has approved an expanded plaque psoriasis indication for Cosentyx®
(secukinumab), manufactured by Novartis. The drug is now indicated to
June 1, 2021
June 1, 2021 – The U.S. FDA has approved Lybalvi TM (olanzapine/samidorphan) tablets, manufactured by
Alkermes, for the following indications for adult patients
June 1, 2021
June 1, 2021 – The U.S. FDA has granted accelerated approval to TruseltiqTM (infigratinib), manufactured
by BridgeBio and Helsinn Therapeutics, to treat adults who have previously
May 28, 2021
May 28, 2021 – The U.S. FDA has approved an expanded indication for Zipsor® (diclofenac potassium),
manufactured by Assertio Therapeutics, to provide relief of mild to
May 28, 2021
May 28, 2021 – The U.S. FDA has granted accelerated approval to LumakrasTM (sotorasib), manufactured
by Amgen, to treat KRAS G12C-mutated
May 27, 2021
May 27, 2021 – The U.S. FDA has approved Pylarify® (piflufolastat F 18), manufactured by Progenics
Pharmaceuticals, for positron emission tomography (PET) of prostate-specific