Industry Dynamics

Industry News

08-04

2023

FDA Grants Traditional Approval for LEQEMBI® (lecanemab-irmb) for the Treatment of Alzheimer’s Disease

July 06, 2023 -- Today, the U.S. Food and Drug Administration converted Leqembi (lecanemab-irmb), indicated to treat adult patients with Alzheimer’s Disease, to traditional approval following a determination that a confi……

06-26

2023

U.S. FDA Approves First Anti-Inflammatory Drug for Cardiovascular Disease

June 20, 2023 -- AGEPHA Pharma USA, LLC, today announced that, following a Priority Review, the U.S. Food and Drug Administration (FDA) has approved LODOCO® as the first anti-inflammatory atheroprotective cardi……

06-15

2023

Over 14.2 billion! AstraZenda has become a blockbuster cooperation

AstraZeneca has entered into an exciting collaboration, exclusive option and license agreement with Quell Therapeutics to develop multiple engineered T-regulator (Treg) cell therapies that have the potential to be curati……

05-31

2023

Lexicon Announces FDA Approval of INPEFA™ (sotagliflozin) for Treatment of Heart Failure

May 26, 2023 -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the U.S. Food and Drug Administration (FDA) has approved INPEFA™ (sotagliflozin), a once-daily oral tablet to reduce the risk of cardiovas……

05-15

2023

FDA Approves First Drug to Treat Agitation Symptoms Associated with Dementia due to Alzheimer’s Disease

May 22, 2023 -- Today, the U.S. Food and Drug Administration is announcing the supplemental approval of Rexulti (brexpiprazole) oral tablets for the treatment of agitation associated with dementia due to Alzheimer’s dise……

04-27

2023

R21/Matrix-M™ malaria vaccine developed by University of Oxford receives regulatory clearance for use in Ghana

April 20, 2023 -- The University of Oxford-developed and Serum Institute of India PvT Ltd (SIIPL)- manufactured and scaled up R22/Matrix-MTM malaria vaccine, leveraging Novavax’s adjuvant technology, has been licensed fo……

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