Industry Dynamics

Industry News

11-10

2021

FDA Grants Fast Track Designation to AstraZeneca’s Fasenra for Eosinophilic Gastritis

Nov. 8, 2022 -- The U.S. Food and Drug Administration granted Fast Track designation to AstraZeneca’s Fasenra for the treatment of eosinophilic gastritis with or without eosinophilic gastroenteritis. Fasenra was also gra……

10-26

2021

Bristol Myers Squibb Receives European Commission Approval for Opdivo (nivolumab) + Chemotherapy for Patients with HER2 Negative, Advanced or Metastatic Gastric, Gastroesophageal Junction or Esophageal Adenocarcinoma

October 22, 2022 -- Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for……

10-21

2021

US FDA approves Roche’s Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer

October 25, 2022 – Roche today announced that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Sta……

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……

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