Industry Dynamics

Industry News

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……

03-07

2022

U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

March 02, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) has approved CARVYKTI™ (ciltacabtagene autoleucel; cilta-cel) for the treatment of ad……

02-28

2022

European Commission Approves TEPMETKO® (tepotinib) for Patients with Advanced NSCLC with METex14 Skipping Alterations

February 28, 2022 —Merck, a leading science and technology company, today announced that the European Commission (EC) has approved once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients ……

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……

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