Commercial launch of neffy® (epinephrine nasal spray) underway in the United StatesSupplemental NDA for neffy®1mg dose granted priority review by FDA; PDUFA target date set for March 6, 2025Exclusive ...

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 ...

SAN FRANCISCO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2024 and provided an update on the company’s recent developments.

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

The FDA informed Intercept that it is unable to approve the sNDA in its current form, consistent with the outcome of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting in September 2024. In ...

Syndax Pharmaceuticals (SNDX) stock dropped ~23% after the company posted Phase 2 trial data for its AML candidate, revumenib ...

This drug is the world’s first-ever CRISPR/Cas13 RNA-editing therapy for clinical use in treating neovascular age-related macular degeneration (nAMD). The US FDA has cleared an investigational new ...

It has been a year since the FDA announced their goals for the future of animal and veterinary products in the Animal and Veterinary Innovation Agenda (available here: Animal and Veterinary Innovation ...

Sunvozertinib has shown promising results in patients with non–small cell lung cancer with an EGFR exon 20 insertion mutation ...

Topline results are expected in Q4 2025 and Averitas Pharma aims to submit a supplemental new drug application (sNDA) for a US label extension in 2026, subject to positive data. Grünenthal announced ...