Biogen

Survodutide Phase II trial Shows Groundbreaking Results in Liver Disease due to MASH, with Significant Improvements in Fibrosis Boehringer Ingelheim has reported that in a Phase II trial, a significant proportion of adults treated with survodutide (BI 456906), up to 83.0%, showed a notable enhancement in metabol...

GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation ai...

Eisai Submits Marketing Authorization Application In Japan for Anticancer Agent Tasurgratinib For Biliary Tract Cancer With FGFR2 Gene Fusion Eisai Co., Ltd. has officially submitted a request for marketing authorization in Japan for tasurgratinib succinate, its internally developed tyrosine kinase inhibitor tar...

Alzheimer’s, the most common type of dementia, particularly with an increasing geriatric population, presents a major global crisis. The disease mostly occurs in sexagenarians, but it may manifest in quadragenarians. It is one of the most prevalent neurodegenerative disorders with a multifactorial pathogenesis. It ...

Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera On Sept. 20, 2023, Disc Medicine, Inc. (NASDAQ: IRON) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with Polycyt...

In a bittersweet decision for Biogen and Sage Therapeutics, the FDA approved the fast-acting drug zuranolone as the first tablet for postpartum depression on 04 August —but rejected the drug for major depressive disorder treatment. Zurzuvae is a neuroactive steroid that acts as a GABA-A receptor-positive allosteric...

FDA Approves ZURZUVAE, the First and Only Oral Treatment Approved for Women with Postpartum Depression Biogen Inc. and Sage Therapeutics, Inc. announced that the FDA has approved ZURZUVAE (zuranolone) 50 mg for individuals with postpartum depression (PPD). ZURZUVAE is the first and only 14-day oral, once-daily t...

FDA Expands GSK’s Jemperli Approval for Endometrial Cancer GSK plc announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab) in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent for the treatment of adult patients with mismatch repair deficient...

Astellas Announces FDA Grants Priority Review for Zolbetuximab Biologics License Application Astellas Pharma Inc. announced that the FDA has accepted and granted Priority Review for the company's Biologics Licence Application (BLA) for zolbetuximab, a first-in-class investigational Claudin 18.2 (CLDN18.2)-target...

FDA Grants Priority Review to Luspatercept for First-line Treatment of Anemia in Lower-risk MDS The FDA has granted priority review to a supplemental biologics license application (sBLA) seeking to expand the current indication of luspatercept-aamt (Reblozyl) to include treatment of anemia in patients with very ...