FDA grants Beam Therapeutics a Regenerative Medicine Advanced Therapy designation for BEAM-101, an investigational gene-edited cell treatment for sick...
The Multidisciplinary Association for Psychedelic Studies calls on HHS and FDA to quickly approve its NDA for MDMA-assisted therapy that was rejected ...
President Trump issues an Executive Order requiring HHS to obtain critical drug active pharmaceutical ingredients to be stored in a strategic reserve.
After two deaths in trial, Schrdinger decides to stop developing SGR-2921, its CDC7 inhibitor being evaluated in a Phase 1 dose-escalation study.
FDA grants Halda Therapeutics a Fast Track designation for HLD-0915 and its use for treating metastatic castration-resistant prostate cancer.
A Foley & Lardner client petitions FDA not to approve ANDAs citing Ozempic as the reference-listed drug unless restrictions sought in the petition are...
FDA publishes a CDER Manual of Policies and Procedures outlining the Centers Equal Voice process for ensuring that all staff are heard and valued in p...
HHS revives a task force on safer childhood vaccines, a federal panel created by Congress to improve child vaccine safety, quality, and oversight.
