FDA Specialty Approvals

New FDA Specialty Approvals

✦ Nov. 9: The FDA expanded the label of Foundation Medicine, Inc.’s FoundationOne Liquid CDx to identify people with BRCA1, BRCA2 and/or ATM alterations in metastatic castration-resistant prostate cancer who may...

New FDA Specialty Approvals

✦ Oct. 7: The FDA expanded the label of BioMarin Pharmaceutical Inc.’s Palynziq (pegvaliase-pqpz) to increase the maximum allowable dose to 60 mg for the treatment of adults with phenylketonuria. The agency init...

New FDA Specialty Approvals

✦ Sept. 16: The FDA expanded the use of Roche’s CINtec PLUS Cytology test to help clinicians determine which women who test positive for human papillomavirus (HPV) via cobas 6800/8800 Systems require further dia...

New FDA Specialty Approvals

✦ Aug. 5: The FDA gave accelerated approval to GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf) for adults with relapsed or refractory multiple myeloma who have received at least four prior therapies, inclu...

New FDA Specialty Approvals

✦ July 7: The FDA approved Astex Pharmaceuticals, Inc., Taiho Oncology, Inc. and Otsuka Pharmaceutical Co., Ltd.’s Inqovi (decitabine and cedazuridine) for the treatment of adults with intermediate and high-risk...

New FDA Specialty Approvals

✦ May 29: The FDA expanded the label of Eli Lilly and Co.’s Cyramza (ramucirumab) to include, in combination with erlotinib, the first-line treatment of people with metastatic non-small cell lung cancer with EGF...

New FDA Specialty approvals

✦ May 6: The FDA gave accelerated approval to Novartis Pharmaceuticals Corp.’s Tabrecta (capmatinib) for adults with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesen...

New FDA Specialty Approvals

✦ April 8: The FDA granted an additional approval to Pfizer Inc. subsidiary Array BioPharma Inc.’s Braftovi (encorafenib) in combination with Lilly USA, LLC’s Erbitux (cetuximab) for the treatment of adults wi...

New FDA Specialty Approvals

✦ March 9: The FDA approved Acacia Pharma Group plc’s Barhemsys (amisulpride) for the prevention of postoperative nausea and vomiting in adults either alone or with an antiemetic of a different class and treatme...

New FDA Specialty Approvals

✦ Feb. 10: The FDA granted final approval to Eagle Pharmaceuticals, Inc.’s Pemfexy (pemetrexed) for the treatment of people with locally advanced or metastatic nonsquamous non-small cell lung cancer in combinati...