FDA Priority Review

The FDA has accepted Agios Pharmaceuticals Inc's (NASDAQ: AGIO) marketing application seeking approval for mitapivat for pyruvate kinase (PK) deficiency. Under Priority Review designation, the agency's action date is assigned as of February 17, 2022. Related: Agios...

Liminal BioSciences Inc's (NASDAQ: LMNL) subsidiary Prometic Biotherapeutics Inc has agreed to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $105M. The FDA granted the PRV with the approval of Ryplazim (plasminogen, human-tvmh) for plasminogen deficiency type...

The FDA has accepted for review Daré Bioscience Inc's (NASDAQ: DARE) marketing application for DARE-BV1 for bacterial vaginosis. Under the priority review, the target goal date is December 7. DARE-BV1 is an investigational thermosetting bioadhesive hydrogel containing...

The FDA has granted priority review for Genentech's, a unit of Roche Holdings AG (OTC: RHHBY) Tecentriq (atezolizumab), as adjuvant treatment for certain patients with early non-small cell lung cancer.  The application covers patients following surgery and...