The greenlight for Journavx (suzetrigine), which comes on the heels of a $7.4 billion opioid settlement, could spark momentum ...

The Pre-Investigational New Drug Application (IND) Consultation Program fosters early communications between sponsors and new drug review divisions to provide guidance on the data necessary to warrant ...

The US Food and Drug Administration (FDA) has approved the abbreviated new drug application (ANDA) of Lupin’s Sacubitril and Valsartan tablets for heart failure patients. Sacubitril and Valsartan ...

The last decade has seen a “dramatic increase” in investigational new drug (IND) applications for cannabis-derived products, according to the U.S. Food and Drug Administration. In a paper ...

Corstasis Therapeutics Inc. ( a clinical-stage MedTech pharmaceutical company developing innovative, practical therapies for fluid overload, today announced that the U.S. Food and Drug Administration ...

had accepted the company’s New Drug Application (NDA) for TNX-102 SL, a 5.6 mg non-opioid analgesic for managing fibromyalgia, a chronic pain condition affecting over 10 million adults in the U ...

for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the investigational combination of avutometinib and defactinib in adults with recurrent KRAS mutant LGSOC who ...