Industry Dynamics

Industry News

10-30

2020

FDA Approves Expanded Indication for Merck’s KEYTRUDA® (pembrolizumab) in Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (cHL)

October 25, 2020 -- MSD, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for KEYTRUDA, Merck’s anti-PD-2 therapy, as monotherapy for the treatment of adult patients with re……

10-09

2020

Kyowa Kirin Announces European Commission (EC) Approval of CRYSVITA® (burosumab) for the Treatment of X-Linked Hypophosphataemia (XLH) in Older Adolescents and Adults

October 5, 2020 – Kyowa Kirin Co., Ltd. today announced that the European Commission (EC) has approved CRYSVITA® (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphataemia (XLH).……

09-29

2020

FDA Approves KALYDECO® (ivacaftor) as First and Only CFTR Modulator to Treat Eligible Infants With CF as Early as Four Months of Age

September 26, 2020 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved KALYDECO® (ivacaftor) for use in children with cystic fibrosis (CF) ages four ……

09-07

2020

FDA approves additional doses of Trulicity? (dulaglutide) for the treatment of type 2 diabetes

Sept. 3, 2020 -- The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company's (NYSE: LLY) Trulicity? (dulaglutide). The approval expands the label of once-weekly Trulicit……

08-31

2020

FDA approves Novartis Kesimpta? (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

August 20, 2020 ― Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta? (ofatumumab, formerly OMB257) as an injection for subcutaneous use for the treatment of relapsing forms of ……

08-03

2020

MYR Pharmaceuticals receives Conditional Marketing Authorization by the European Commission for HEPCLUDEX?

Aug. 4, 2020 -- MYR Pharmaceuticals, a German biotechnology company focused on the development and commercialization of therapeutics for the treatment of chronic hepatitis B and D, is pleased to announce that the Europea……

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