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Industry Dynamics

Industry News

06-15

2022

FDA Approves Genentech’s Evrysdi (risdiplam) For Use in Babies Under Two Months with Spinal Muscular Atrophy (SMA)

June 2, 2022 --Genentech, a member of the Roche Group, recently announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi? (risdiplam) to include babies under two months old wi……

05-30

2022

FDA approves Dupixent? (dupilumab) as first treatment for adults and children aged 12 and older with eosinophilic esophagitis

May 25, 2022-Sanofi and its partner Regeneron jointly announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent? (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE)……

05-16

2022

FDA approves Lilly's Mounjaro? (tirzepatide) injection, the first and only GIP and GLP-1 receptor agonist for the treatment of adults with type 2 diabetes

May 23, 2022- The U.S. Food and Drug Administration (FDA) approved Mounjaro? (tirzepatide) injection, Eli Lilly and Company's (NYSE: LLY) new once-weekly GIP (glucose-dependent insulinotropic……

04-29

2022

TAKHZYRO? (lanadelumab) Open Label Phase 3 Study Met its Objectives in Children Ages 2 to <12 Years of Age with Hereditary Angioedema (HAE)

Apr. 20, 2022-Takeda today announced that the Phase 3 SHP643-302 study evaluating the safety profile and pharmacokinetics (PK) of TAKHZYRO? (lanadelumab) in patients 2 to ……

04-06

2022

RESPONSIBILITIES OF THE MARKETING AUTHORISATION HOLDER

Marketing Authorisation Holder:EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime in relation to its safety, quality and efficacy, lies with the Marketing Aut……

03-31

2022

First and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder (CDD)

Mar. 24th, 2022-Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders announced that the U.S. Food and Drug Administrati……

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