Industry Dynamics

Industry News

07-29

2021

FDA Approves New Use of Transplant Drug Based on Real-World Evidence

July 26, 2022 -- Today, the U.S. Food and Drug Administration approved a new use for Prograf (tacrolimus) based on a non-interventional (observational) study providing real-world evidence (RWE) of effectiveness. FDA appr……

07-13

2021

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

July 9, 2022 -- Astellas Pharma Inc. and Seagen Inc. today announced the U.S. Food and Drug Administration (FDA) granted PADCEV® (enfortumab vedotin-ejfv) regular approval in the U.S., in addition to approving a new indi……

06-29

2021

Roche’s Actemra/RoActemra receives U.S. FDA Emergency Use Authorization for the treatment of COVID-19

26 June, 2022 -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for intravenous Actemra/RoActemra® (tocilizumab) for th……

06-10

2021

Alexion Announces FDA Approval of ULTOMIRIS® (ravulizumab-cwvz) for Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)

2022.06.07 -- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of ULTOMIRIS® (ravulizumab-cwvz) to include children ……

05-31

2021

FDA APPROVES BIOHAVEN'S NURTEC® ODT (RIMEGEPANT) FOR PREVENTION: NOW THE FIRST AND ONLY MIGRAINE MEDICATION FOR BOTH ACUTE AND PREVENTIVE TREATMENT

May 27, 2022 -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN), today announced that the U.S. Food and Drug Administration (FDA) has approved NURTEC® ODT (rimegepant 75 mg) for the preventive treatment of migr……

05-17

2021

Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF™ (HTX-011) for the Management of Postoperative Pain for up to 72 Hours

May 23, 2022 -- Heron Therapeutics, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ZYNRELEF (bupivacaine and meloxicam) extended-release solution for use in adults for soft tissue or p……

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