Industry Dynamics

Industry News

02-17

2022

Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment

February 22, 2022 -- Pfizer Inc. recently announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending the conditional marketing a……

01-31

2022

FDA approves Nucala (mepolizumab) 40 mg prefilled syringe for children with severe eosinophilic asthma

Jan. 24, 2022----GlaxoSmithKline plc (GSK) announced that the US Food and Drug Administration (FDA) has approved a 40 mg prefilled syringe of Nucala (mepolizumab) for appropriate children aged 6 to 22 years old who have ……

01-19

2022

U.S. FDA Approves Pfizer’s CIBINQO® (abrocitinib) for Adults with Moderate-to-Severe Atopic Dermatitis

Jan. 25, 2022-- Pfizer Inc. (NYSE: PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 2 (JAK2) inhibitor, for the……

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 ……

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