KeyMed Biosciences (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the supplemental New Drug Application (the "sNDA") of ...

ARS Pharmaceuticals launched Neffy, the first FDA-approved needle-free epinephrine nasal spray for severe allergic reactions.

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic pheochromocytoma and paraganglioma.

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...

The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.

Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...

The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.

Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...

Exelixis, Inc. (Nasdaq: EXEL) today announced results from a subgroup analysis of the phase 3 CABINET pivotal study of ...

London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves ...

The FDA has accepted a supplemental New Drug Application for a higher dose regimen of nusinersen (Spinraza; Biogen Inc) for spinal muscular atrophy (SMA), according to a recent announcement from ...