FDA authorizes the use of Cook Medicals Flourish Pediatric Esophageal Atresia Anastomosis, a device to treat infants up to one year old for a birth de...
Holding some hope for a Trump Administration change of heart, the Alliance for a Stronger FDA calls its proposed 37% FDA budget cut in 2018 a non-star...
FDA grants Loxo Oncology an orphan drug designation for larotrectinib for treating solid tumors with NTRK-fusion proteins, which are genetic abnormali...
AstraZeneca and MedImmune announce positive results from their Phase 3 PACIFIC trial, a randomized, double-blinded, placebo-controlled trial of Imfinz...
Alzheimers disease researchers urge FDA to clarify and modernize its current approach for approving new treatments for Alzheimers.
FDA says Exact-Rx must correct deficiencies in the listing for its Sulfacetamide and Sulfer Cleanser.
Attorney Armandeep Sindhu says the 3rd Circuit Appeals Court affirmed a lower court ruling dismissing a whistleblower case against Genentech over its ...
FDA releases the FDA-483 with eight inspection observations from a recent inspection at Indias Biocon Limited.