Hosted on MSN4h
Stealth faces another hurdle as FDA delays decision on Barth syndrome drug
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
Medscape5h
FDA OKs Esketamine Nasal Spray Monotherapy for Resistant Depression
The expanded indication allows esketamine nasal spray to be used as a standalone treatment in adults with MDD who have not ...
Govt Decides To Extend Term Of Drug Controller General While Examining 18 Candidates For Post
Explaining the decision to re-employ the current drug controller general of India, the health ministry has told the ...
FDA approves drug application for Lupin’s heart failure therapy
The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and ...
Taiwan News9h
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that its Marketing Authorization Application (MAA) for ...
News Medical21h
New AI software could speed up drug development
The discovery and development of drugs in pharmacological research – including the risk assessment of active substances in ...