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News about "Food and Drug Administration "
US Food and Drug Administration Extends Review Timeline for Sarclisa Subcutaneous Formulation
FDA extends review timeline for Sanofi’s Sarclisa subcutaneous formulation, a potential first-in-class on-body injector therapy for multiple myeloma patients.
Food And Drug Administration | 23/04/2026 | By News Bureau
US Food and Drug Administration Urges Compliance on Clinical Trial Reporting to Address Data Gaps
The US Food and Drug Administration has issued reminders to over 2,200 companies and researchers to submit clinical trial results, aiming to reduce reporting gaps and improve transparency in drug development.
Food And Drug Administration | 15/04/2026 | By News Bureau
Alembic Pharmaceuticals Secures US FDA Approval for Paroxetine ER Tablets
U.S. Food and Drug Administration grants final approval to Alembic’s sANDA for paroxetine extended-release tablets, used in treating depression and anxiety-related disorders.
Food And Drug Administration | 30/03/2026 | By News Bureau
Belief Pharmaceuticals' Haemophilia B Gene Therapy Approved in Macau
Macau approves Belief Pharmaceuticals’ Popedacoq gene therapy for haemophilia B, marking regional expansion after China approval and advancing access to one-time treatment solutions.
Food And Drug Administration | 23/03/2026 | By News Bureau
Novo Nordisk Wins FDA Approval for Wegovy HD to Advance Obesity Treatment
FDA approves Novo Nordisk’s Wegovy HD (semaglutide 7.2 mg), a higher-dose weekly injection delivering significant weight loss, supported by strong Phase III trial outcomes.
Food And Drug Administration | 21/03/2026 | By News Bureau | 108
GSK Secures FDA Approval for Lynavoy, First Treatment for PBC-Related Chronic Itch
FDA approves GSK’s Lynavoy (linerixibat), the first therapy for cholestatic pruritus in primary biliary cholangitis patients, offering significant and sustained itch relief.
Food And Drug Administration | 21/03/2026 | By News Bureau
BioVersys AG receives US Food and Drug Administration nod to include US patients in Phase III BV100 trial targeting drug-resistant pneumonia, marking progress in combating deadly hospital infections globally.
Food And Drug Administration | 18/03/2026 | By News Bureau
Shanghai UniXell Biotechnology. has received US Food and Drug Administration IND clearance for UX-GIP001, marking the first iPSC-derived allogeneic cell therapy to enter clinical trials for Epilepsy in the US.
Food And Drug Administration | 17/03/2026 | By News Bureau | 150
Qiagen N.V. has secured U.S. Food and Drug Administration clearance for QIAstat-Dx GI Panels on its QIAstat-Dx Rise system, enabling laboratories to run respiratory and gastrointestinal syndromic tests on a single automated platform.
Food And Drug Administration | 13/03/2026 | By News Bureau | 113
US Food and Drug Administration grants Priority Review to supplemental application for Enhertu to treat HER2-positive breast cancer patients with residual disease after neoadjuvant therapy, with decision expected in Q3 2026.
Food And Drug Administration | 10/03/2026 | By News Bureau | 106
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