FDA clears a Phase 3 protocol amendment to allow a time-based analysis of Glycomimetics uproleselan if sufficient survival events for an event-driven ...
Public Citizens Health Research Group urges FDA to not grant accelerated approval to Sarepta Therapeutics gene therapy SRP-9001 for treating ambulator...
FDA clears an American Laboratory Products 510(k) for its Calprotectin Immunoturbidimetric Assay as an aid in diagnosing inflammatory bowel disease.
FDA issues a partial clinical hold against Mersana Therapeutics clinical trials of UpRi (upifitamab rilsodotin) in platinum-sensitive ovarian cancer.
Aldeyra Therapeutics says the Phase 3 INVIGORATE-2 Clinical Trial of 0.25% reproxalap ophthalmic solution in patients with allergic conjunctivitis met...
A Florida federal judge stays the states Administrative Procedure Act claims against FDA over the states drug import plan until 11/1, noting that FDA ...
Pfizer says select presentations of its Bicillin L-A and Bicillin C-R prefilled syringes are expected to be depleted later this year.
FDA clears a Surmodics 510(k) for its Pounce LP (Low Profile) Thrombectomy System.
