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FDA grants ReAlta Life Sciences orphan drug and fast track designations for RLS-0071 and its use in treating hospitalized patients...[ Price : $8.95]
Federal Register notice: FDA determines that Horizon Therapeutics Pennsaid (diclofenac sodium) topical solution 2% was not withdra...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Product-Specific Guidance Meetings Between FDA and ANDA App...[ Price : $8.95]
FDA approves a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of c...[ Price : $8.95]
FDA clears a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusi...[ Price : $8.95]
FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for tre...[ Price : $8.95]
FDA lifts a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a H...[ Price : $8.95]
CDRH grants a de novo marketing authorization for SoCleans 3+ Bacterial Reduction Device, an over-the-counter product intended to ...