FDA Specialty Approvals

New FDA Specialty Approvals

✦ July 30: The FDA granted premarket approval to Pillar Biosciences, Inc.’s ONCO/Reveal Dx Lung and Colon Cancer Assay as a companion diagnostic for all FDA-approved epidermal growth factor receptor tyrosine kin...

New FDA Specialty Approvals

✦ July 9: The FDA gave an additional approval to Astellas Pharma US, Inc. and Seagen Inc.’s Padcev (enfortumab vedotin-ejfv) for the treatment of adults with locally advanced or metastatic urothelial cancer who ...

New FDA Specialty Approvals

✦ June 7: The FDA granted another indication to Alexion Pharmaceuticals, Inc.’s Ultomiris (ravulizumab-cwvz) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) in children at least 1 month old and ad...

New FDA Specialty Approvals

✦ May 5: The FDA granted accelerated approval to Merck & Co., Inc.’s Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the treatment of loca...

New FDA Specialty Approvals

✦ April 6: The FDA approved a new dosing regimen for Eli Lilly and Co.’s Erbitux (cetuximab) of 500 mg/m2 as a 120-minute infusion every two weeks as a single agent or in combination with chemotherapy for people...

New FDA Specialty Approvals

✦ Feb. 3: The FDA gave accelerated approval to Merck KGaA unit EMD Serono, Inc.’s Tepmetko (tepotinib) for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithel...

New FDA Specialty Approvals

✦ Jan. 14: The FDA granted an additional indication to Pfizer Inc.’s Xalkori (crizotinib) to treat children at least 1 year old and young adults with relapsed or refractory, systemic anaplastic large cell lympho...

New FDA Specialty Approvals

✦ Dec. 14: The FDA approved a new dosing time for Roche Group unit Genentech USA, Inc.’s Ocrevus (ocrelizumab) to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, ...

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...