News about "Food and Drug Administration "

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 |  103

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 Advances BV100 Phase III Trial as US Food and Drug Administration Clears US Patient Enrollment

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 Secures US FDA IND Clearance for UX-GIP001, First iPSC-Derived Cell Therapy for Epilepsy

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 |  133

Qiagen N.V. Receives U.S. Food and Drug Administration Clearance for QIAstat-Dx GI Panels on QIAstat-Dx Rise System

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 |  102

AstraZeneca and Daiichi Sankyo Secure US Food and Drug Administration Priority Review for Enhertu in HER2-Positive Breast Cancer

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

U.S. Food and Drug Administration Grants De Novo Classification to LifeVac as Second-Line Emergency Treatment

U.S. Food and Drug Administration grants De Novo clearance to LifeVac, classifying it as a Class II medical device for use as a second-line treatment in choking emergencies.

Food And Drug Administration | 09/03/2026 | By News Bureau |  235

U.S. Food and Drug Administration Approves Tec-Dara Combination Therapy for Relapsed Multiple Myeloma

U.S. Food and Drug Administration grants rapid approval to Tec-Dara, a combination of teclistamab and daratumumab hyaluronidase-fihj, for adults with relapsed or refractory multiple myeloma after at least one prior therapy.

Food And Drug Administration | 07/03/2026 | By News Bureau