Federal Register notice: FDA adds quinacrine hydrochloride to its list of bulk drug substances (active pharmaceutical ingredients for which there is a...
Janssen Biotech and Pharmacyclics decide to voluntarily withdraw two accelerated approval indications for Imbruvica (ibrutinib) treating patients wit...
U.S. Representative Andy Kim (D-NJ) reintroduces a bill to provide FDA with mandatory recall authority for any and all faulty or unsafe prescription a...
Florida wins a $600,000 payment to the states Medicaid program under a multistate action against cochlear implants maker Advanced Bionics and its devi...
FDA explores whether it can enter into a five-year contract with an entity that can perform non-invasive high-resolution imaging and artificial intell...
Yale University researchers suggest five steps FDA could consider to help build patient and clinician trust in drug accelerated approvals.
Pfizer-supported research shows its investigational bivalent RSV prefusion F protein-based vaccine succeeded in preventing RSV-associated lower respir...
The International Council for Harmonization gives final approval to a guidance on assessing and controlling mutagenic impurities in drugs to limit can...
