[ Price : $8.95]
FDA clears a Pixee Medical 510(k) for its Knee +, a surgical platform designed to assist orthopedic surgeons by providing real-tim...[ Price : $8.95]
FDA releases summaries from three Biosimilar User Fee reauthorization negotiating sessions.[ Price : $8.95]
An FDA advisory committee votes to recommend continued accelerated approvals separately for Mercks Keytruda and Genentechs Tecentr...[ Price : $8.95]
Enzyvant resubmits a BLA for RVT-802, a tissue-based regenerative therapy designed to treat pediatric congenital athymia.[ Price : $8.95]
A required preapproval inspection delays Sol-Gel Technologies NDA review for Epsolay (benzoyl peroxide) 5% topical cream for treat...[ Price : $8.95]
FDA publishes a draft guidance on nonclinical information supporting an IND for some antisense oligonucleotides.[ Price : $8.95]
Attorney Sara Koblitz explains the importance of a recent 5th Circuit Court of Appeals decision in an FTC pay-for-delay case.[ Price : $8.95]
FDA grants Medtronic a breakthrough device designation for the Emprint ablation catheter kit, which is intended to be used in conj...