UPDATE: SpringWorks Therapeutics Announces FDA Approval of GOMEKLIâ„¢ (mirdametinib) for the Treatment of Adult and Pediatric Patients with NF1-PN
GOMEKLI is the first and only medicine approved for both adults and children with NF1-PN –– Approval based on positive data ...
Biohaven stock rises following FDA review and Deutsche Bank's buy rating
Shares of Biohaven Ltd. (NYSE: BHVN) climbed 7% as the company announced the FDA's acceptance and Priority Review of its ...
Biohaven’s troriluzole NDA in spinocerebellar ataxia accepted by the FDA
Biohaven (BHVN) announced that the FDA has accepted for review the company’s New Drug Application, or NDA, for troriluzole for the treatment of ...
Biohaven Announces FDA Acceptance And Priority Review Of Troriluzole New Drug Application For The Treatment Of Spinocerebellar Ataxia
Melissa Beiner, M.D., SCA Clinical Development Lead at Biohaven, commented, Our NDA filing is the culmination of over 8 years of clinical research a ...
Business Wire1d
LIB Therapeutics Announces FDA Acceptance of Biologics License Application for Lerodalcibep to Lower LDL-Cholesterol Across Broad Patient Population
LIB Therapeutics Inc. (LIB), a privately-held, late-stage biopharmaceutical company today announced the U.S. Food and Drug Administration (FDA) has ac ...
Healio8d
FDA receives biologics license application for apitegromab in spinal muscular atrophy
A Boston-area biopharmaceutical firm has submitted a biologics license application to the FDA for its investigational, fully ...
GlobalData on MSN13d
FDA gives RMAT designation to Beacon’s retinitis pigmentosa treatment
The FDA has granted RMAT designation to Beacon Therapeutics’ gene therapy, laru-zova, for treating X-linked retinitis ...
ophthalmologytimes8d
CHMP of the European Medicines Agency issues positive opinion on 2 aflibercept biosimilars
The two products, both manufactured by Amgen, are aflibercept biosimilars Pavblu and Skojoy. Both biosimilars are indicated ...
US FDA approves Novo Nordisk's Ozempic to reduce risk of kidney diseases in diabetic patients
Breakthrough in diabetes treatment! The US FDA approves Ozempic for reducing kidney disease risk in diabetic patients. Learn ...
Biohaven Ltd.: Biohaven Announces FDA Acceptance and Priority Review of Troriluzole New Drug Application for the Treatment of Spinocerebellar Ataxia
Spinocerebellar Ataxia (SCA) is a rare, genetic, life-threatening neurodegenerative disease with no available treatment. Troriluzole demonstrated a 50-70% slowing of SCA disease progression ...