Industry Dynamics

Industry News

09-20

2021

Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer

Sep. 27, 2022 -- Exelixis, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX® (cabozantinib) for the treatment of adult and pediatric patients 22 years of age and older with locally……

09-10

2021

Impel NeuroPharma Announces U.S. FDA Approval of TRUDHESA™ (Dihydroergotamine Mesylate) Nasal Spray for the Acute Treatment of Migraine

Sept. 03, 2022 -- Impel NeuroPharma, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved TRUDHESA™ (dihydroergotamine mesylate) nasal spray (0.725 mg per spray) for the acute treatment of migra……

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……

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