FDA clears the BD Vaginal Panel running on the BD COR System to detect the three most common causes of vaginitis.
GlaxoSmithKline says its meningococcal MenABCWY vaccine candidate met all 11 primary endpoints in a pivotal Phase 3 trial.
FDA publishes an International Pharmaceutical Regulators Program reflection paper addressing general considerations for using raw materials in the man...
The Senate Appropriations Committee announces a 4/19 subcommittee hearing to review FDAs fiscal year 2024 budget request.
An FDA Advisory Committee votes 16 to 1 that Pfizers Paxlovid (nirmatrelvir and ritonavir) has a favorable benefit-risk profile for treating mild-to-m...
FDA commissioner Robert Califf calls on health insurers to play a role in seeing that confirmatory trials are completed for drugs approved through the...
FDA publishes a draft guidance on using electronic systems, records, and signatures in clinical investigations of some regulated products.
FDA modifies a partial clinical hold against Stoke Therapeutics to allow the administration of a higher single dose of STK-001 (70 mg) in its ongoing ...
