U.S FDA

QOL Medical, LLC, a ground-breaking, rare disease pharmaceutical company, announced today that the United States (U.S.) Food & Drug Administration (FDA) approved Sucraid® single-use containers…

Summary: Orkambi was first approved in 2015 in the US and is now available in more than 30 countries.  Vertex Pharmaceuticals Incorporated…

Synopsis: German drugmaker Boehringer Ingelheim has its first regulatory approval for spesolimab, its antibody therapy for rare and life-threatening skin disorder generalised…

Summary: XenpozymeTM (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations)  Xenpozyme is the first approved medication to treat symptoms that are not related…

Synopsis : This marks the second indication for Pemazyre, which received accelerated FDA approval in 2020 for adults with previously treated, unresectable…

Summary: The FDA has approved Axsome Therapeutics’ Auvelity for major depressive disorder (MDD) in adults, making it the first and only oral…

Summary: Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved for children as young…

Synopsis: Based on DESTINY-Breast04 results which showed Daiichi Sankyo and AstraZeneca’s ENHERTU reduced risk of disease progression or death by 50% and…

Summary : Marius Pharmaceuticals, a patient-centric healthcare company, today announced the approval of KYZATREX™ (testosterone undecanoate) by the U.S. Food and Drug…

Synopsis : CIMERLI™ is Coherus’ third FDA-approved product and the first of four new product launches planned by the end of 2023 …