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, ...
thecardiologyadvisor.com1d
Nasal Spray Formulation of Bumetanide Under FDA Review
The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.
JD Supra18h
End of an Era: FDA Retires 2017 Interim Policies for Bulk Drug Lists
On January 7, 2025, the US Food and Drug Administration (FDA) issued two parallel guidance documents for the Section 503A and Section 503B bulk ...
Business Wire1mon
Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS ...
Verastem was granted Priority Review and a Prescription Drug User Fee Act (PDUFA) date of June 30, 2025, for its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for the ...
GSK announces new drug applications accepted for review in China, Japan
GSK (GSK) announced that new drug applications have been accepted for review by the China National Medical Products Administration and ...
GlobalData on MSN12d
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.
thecardiologyadvisor.com12d
Plozasiran Under Review for Familial Chylomicronemia Syndrome
2025 has been assigned to the application. The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for plozasiran for the treatment for familial chylomicronemia ...
Monthly Prescribing Reference7d
Belzutifan Gets Priority Review for Advanced Pheochromocytoma and Paraganglioma
The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental New Drug Application (sNDA) for belzutifan for the treatment of adult and pediatric patients aged 12 years and ...
Contract Pharma8d
Merck’s WELIREG Accepted for Priority Review by FDA for Pheochromocytoma and Paraganglioma
The supplemental new drug application is based on data from the Phase 2 LITESPARK-015 trial.
infectiousdiseaseadvisor.com1d
Prefilled Syringe Presentation of Shingrix Under FDA Review
The FDA will review a new prefilled syringe presentation of Shingrix (zoster vaccine recombinant, adjuvanted).
Targeted Oncology7d
FDA Grants Belzutifan Priority Review For Advanced Pheochromocytoma and Paraganglioma
The FDA granted priority review for belzutifan for treating advanced pheochromocytoma and paraganglioma, with a PDUFA date set for May 26, 2025.