FDA extends by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic cardiomyopathy after re...
FDA approves a Satsuma Pharmaceuticals 505(b)(2) NDA for Atzumi (dihydroergotamine (DHE)) nasal powder for the acute treatment of migraine.
FDA approves a Johnson & Johnson BLA for Imaavy (nipocalimab-aahu) for treating generalized myasthenia gravis.
George Washington University law professor Richard Pierce praises a recent unanimous Supreme Court decision backing FDA in an e-cigarette regulation c...
Boehringer Ingelheim releases new findings from its Beamion LUNG-1 trial, highlighting the potential of zongertinib as a breakthrough oral therapy for...
Reps. Alexandria Orcasio-Cortez and Nydia Velzquez ask HHS secretary Robert F. Kennedy, Jr., to reopen the FDA San Juan medical products laboratory th...
Immunic reports positive data from its Phase 2 CALLIPER trial of nuclear receptor related 1 activator vidofludimus calcium (IMU-838) in patients with ...
Gilead Sciences agrees to pay $202 million to resolve claims that the company offered and paid kickbacks (e.g., honoraria payments, meals, and travel ...