An update from Shanghai Henlius Biotech, Inc. Class H ( ($HK:2696) ) is now available. Shanghai Henlius Biotech, Inc. announced that its New Drug ...

The FDA approved an investigational new drug application for ABT-301, clearing the way for a new clinical trial in metastatic ...

The US Food and Drug Administration recently announced the launch of a regulatory incentive program pilot program, the ...

NEW HAVEN, Conn., June 06, 2025 (GLOBE NEWSWIRE) -- Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with ...

U.S. FDA Accepts New Drug Application for Merck’s DOR/ISL Once-Daily Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1.

The FDA accepted a new drug application for Brimochol PF for the treatment of presbyopia and set a Prescription Drug User Fee Act date of Jan. 28, 2026, according to a press release from Tenpoint ...

The initiative is a response to a Trump administration order to speed the construction of the type of new drug factories many ...

The FDA has agreed to fast-track its review of gepotidacin, an oral antibiotic already approved for urinary tract infections, ...

The Food and Drug Administration Aug. 7 announced a new program to help improve the domestic pharmaceutical supply chain by ...

A new FDA program will use a two-phase approach to help boost domestic drug manufacturing, while OpenAI is leaning into health care with the launch of GPT-5.

--Axsome Therapeutics, Inc., a biopharmaceutical company leading a new era in the treatment of central nervous system disorders, today announced it has received a Refusal to File letter from the U ...

U.S. FDA Accepts New Drug Application for Merck’s Doravirine/Islatravir, an Investigational, Once-Daily, Oral, Two-Drug Regimen for Treatment of Adults with Virologically Suppressed HIV-1 ...