Industry Dynamics

Industry News

08-31

2021

Ascendis Pharma A/S Announces U.S. Food and Drug Administration Approval of SKYTROFA® (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency

Aug. 25, 2022 -- Ascendis Pharma A/S, today announced that the U.S. Food and Drug Administration (FDA) has approved SKYTROFA (lonapegsomatropin-tcgd) for the treatment of pediatric patients one year and older who weigh a……

08-16

2021

FDA Approves KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Combination for First-Line Treatment of Adult Patients With Advanced Renal Cell Carcinoma (RCC)

August 22, 2022 -- Merck and Eisai today announced that the U.S. Food and Drug Administration (FDA) has approved the combination of KEYTRUDA, Merck’s anti-PD-2 therapy, plus LENVIMA, the orally available multiple recepto……

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 ……

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