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News about "Food and Drug Administration "
AstraZeneca Wins US Approval for Self-Administered Saphnelo Pen for Lupus Treatment
AstraZeneca launches a self-injectable version of Saphnelo, offering lupus patients a more convenient treatment option with proven efficacy and safety.
Food And Drug Administration | 28/04/2026 | By News Bureau | 142
Alembic Pharmaceuticals Secures US FDA Nod for Fingolimod Capsules
Alembic Pharmaceuticals receives US FDA approval for fingolimod capsules, expanding access to a key multiple sclerosis treatment in the US market.
Food And Drug Administration | 27/04/2026 | By News Bureau | 104
OrganaBio LLC, RxMP Therapeutics Partner for cGMP Manufacturing of Novel Bleeding Control Therapy
OrganaBio LLC partners with RxMP Therapeutics to manufacture RMP-402, a next-generation therapy designed to rapidly stop severe bleeding in both civilian and military settings.
Food And Drug Administration | 27/04/2026 | By News Bureau
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 | 153
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 | 121
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 | 120
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 | 138
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 | 131
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
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