Ezra Announces New FDA Clearance, Enhancing the Capabilities of Its Full-Body Scan Technology
Ezra, the healthcare AI startup revolutionizing early cancer detection through full-body MRI screening, today announced new 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its ...
Business Wire2d
Amneal Launches Mesalamine and Receives U.S. FDA Approval for Lenalidomide
“Mesalamine is a difficult to make product with a limited number of suppliers, and this approval highlights the strength of our R&D capabilities. Additionally, the approval of lenalidomide represents ...
Pharm Exec3d
FDA Approves Bavarian Nordic’s Chikungunya Vaccine Vimkunya
The FDA has approved Bavarian Nordic’s Vimkunya, the first virus-like particle (VLP) chikungunya vaccine for patients over 12 years of age. According to the company, approval was based on strong ...
Bionic Sight’s BS01 Gene Therapy Receives RMAT Designation from the FDA
Company shares preliminary results from Phase 1/2 clinical trial for patients with advanced Retinitis Pigmentosa (RP)NEW YORK, Feb. 18, 2025 ...
Pharmaceutical Technology4d
Bavarian Nordic scoops FDA approval for chikungunya vaccine in adults and teens
Bavarian Nordic sets up a bout with Valneva’s Ixchiq, the former’s Vimkunya already having an edge in population reach.
MarketWatch6d
Vertex Pharmaceuticals stock is soaring. The FDA just approved its potentially game-changing pain treatment.
Shares of Vertex Pharmaceuticals Inc. surged ahead of Friday’s market open after the Food and Drug Administration approved the company’s non-opioid pain treatment. It’s the first new class ...
The Financial Express6d
FDA gives nod to first rapid-acting insulin biosimilar for diabetes treatment
The U.S. Food and Drug Administration (USFDA) on Friday approved Merilog as biosimilar to Novolog (insulin aspart) for the ...
Healio7d
FDA approves subcutaneous Merilog for glycemic control in diabetes
The FDA has approved the first rapid-acting biosimilar insulin product for glycemic control in people with diabetes. Merilog ...
Sanofi gets FDA approval for NovoLog insulin biosimilar
Sanofi (NASDAQ:SNY) has received FDA approval for Merilog, a biosimilar of Novo Nordisk's (NVO) rapid-acting insulin product NovoLog, for the improvement of glycemic control in adults and children ...
Vertex Pharmaceuticals Gets a Huge FDA Approval Which Could Send the Stock Skyrocketing
Obtaining approval from the U.S. Food and Drug Administration (FDA) for a key medication can be a huge catalyst for a ...
RFK Jr. will have a vast global reach at Health and Human Services
In confirmation hearings for his nomination as secretary of the Department of Health and Human Services, the focus was on ...