Jump in fees for new drug applications expected An industry expert, who works in one of the top pharma companies of India, ...

A study of Gila monster venom helped start the revolution in weight-loss drugs. But scientists think that’s just the ...

The authorised ANDA is a therapeutic equivalent of the reference-listed drug (RLD), Corlanor tablets, in the same 5 mg and ...

Submitted New Drug Application (NDA) to FDA for TNX-102 SL for fibromyalgia based on two statistically significant Phase 3 studiesGranted Fast ...

for the ketamine Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 ("GDUFA”) goal date of October 29, 2024. On November 12, 2024, the FDA granted the ...

Johnson & Johnson sued the U.S. Health and Human Services Department on Tuesday, accusing the agency of blocking its plan to ...

AstraZeneca’s earnings were boosted by its oncology, cardiovascular, respiratory and immunology (R&I), and rare disease ...

Syndax Pharmaceuticals advances Revumenib for relapsed AML with FDA decision pending. See why SNDX stock is a key player in ...

Arkansas researchers are testing a product commonly used to treat ticks and fleas on pets to target fly and mosquito larvae ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...