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Approval followed priority review and was based on response rates and duration of response demonstrated in the phase 1b ...
Medpage Today on MSN2d
FDA Approves Brain Tumor Drug Targeting New Mutation
The FDA granted accelerated approval to dordaviprone (Modeyso) as the first systemic therapy for adults and children with ...
The updated label no longer requires Leqvio (inclisiran) to be used in combination with statins for low-density lipoprotein ...
The FDA approved labeling changes for elivaldogene autotemcel (eli-cel; Skysona), a one-time gene therapy for patients with early, active cerebral adrenoleukodystrophy (CALD), to reflect new safety ...
When Jazz Pharmaceuticals' incoming CEO Renee Gala takes the reins at the drugmaker next week, she'll have a brand-new launch ...
The first aceclidine-based eye drop to improve near vision in adults with presbyopia, which affects more than 100 million ...
The FDA will soon require prescription opioid manufacturers to include stronger language on the medications’ labels warning ...
Pharmaceutical Technology on MSN1d
FDA gives accelerated approval to Jazz Pharma’s diffuse midline glioma therapy
The US Food and Drug Administration (FDA) has given accelerated approval to Jazz Pharmaceuticals for Modeyso (dordaviprone) ...
Teva Pharmaceutical (NYSE:TEVA) announced on Wednesday that the U.S. Food and Drug Administration (FDA) approved its migraine therapy Ajovy for children and adolescents, expanding its previous label ...
Dordaviprone (Modeyso) is now approved to treat recurrent H3 K27M-mutant diffuse midline glioma, an ultra-rare, aggressive ...
The FDA has lifted its previously recommended pause on the use of the Chikungunya virus vaccine in individuals 60 and older, following a benefit-risk assessment. The agency also approved updated ...
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