FDA and EMA review Biogen's higher dose SMA drug
CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a $20.8 billion biotechnology company with a robust 75.6% gross profit margin, ...
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FDA Extends Review of Elamipretide for Barth Syndrome
The Food and Drug Administration (FDA) has extended the review period for the New Drug Application (NDA) for elamipretide for the treatment of Barth syndrome, a rare genetic disorder.
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Stealth faces another hurdle as FDA delays decision on Barth syndrome drug
The FDA rejected the company’s initial NDA in 2021, citing the lack of an adequate trial to demonstrate efficacy.
Cure Today11d
FDA Grants Priority Review to Sunvozertinib for EGFR Exon20+ NSCLC
The Food and Drug Administration has accepted and granted priority review to a new drug application for sunvozertinib.
ophthalmologytimes15d
FDA accepts revised supplemental New Drug Application for IZERVAY
The application was refiled following a December 20, 2024, meeting between the US Food and Drug Administration and Astellas.
Cure Today22d
FDA Accepts New Drug Application For Taletrectinib in ROS1+ NSCLC
The FDA has granted priority review to an NDA for taletrectinib in the treatment of advanced ROS1-positive non–small cell lung cancer. The Food and Drug Administration (FDA) has accepted a new drug ...
Targeted Oncology10d
FDA Considers TAR-200 in BCG-Unresponsive High-Risk NMIBC
An FDA application for TAR-200 to treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer is under real-time ...
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Arrowhead Pharmaceuticals Announces Acceptance of New Drug Application by U.S. FDA of Plozasiran for the Treatment of Familial Chylomicronemia Syndrome
Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that the U.S. Food and Drug Administration (FDA) has accepted ...
Monthly Prescribing Reference9d
Prefilled Syringe Presentation of Shingrix Under FDA Review
The new prefilled syringe has the same composition but removes the need for reconstitution, providing a more convenient option for health care providers who administer vaccines. According to the ...
FDA Accepts Arrowhead Pharmaceuticals' Drug Application for Genetic Disease Treatment
Arrowhead Pharmaceuticals said Friday that the Food and Drug Administration accepted the company's new drug application for its treatment of familial chylomicronemia syndrome, a severe and rare ...