Industry Dynamics

Industry News

12-30

2021

FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

December 22, 2022 — Novartis today announced the US Food and Drug Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholester……

12-10

2021

Actemra/RoActemra approved by the European Commission to treat patients with severe COVID-19

December 07, 2022 –Roche today announced that the European Commission has extended the marketing authorisation for Actemra®/RoActemra® (tocilizumab) to include the treatment of COVID-29 in adults who are receiving system……

11-26

2021

Bluebird bio Announces FDA Priority Review of Biologics License Application for beti-cel Gene Therapy for Patients with β-thalassemia Who Require Regular Red Blood Cell Transfusions

Nov. 22, 2022, Bluebird bio, Inc. (Nasdaq: BLUE) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for betibeglogene autotemcel (beti-cel) for ……

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……

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