Abbott advances coronary artery disease treatment with new intravascular lithotripsy trial
Abbott’s Coronary Intravascular Lithotripsy (IVL) System gets FDA approval for a clinical trial to enhance coronary artery disease treatment—learn more. Read More
Danone faces quality concerns as FDA recalls International Delight coffee creamers
Danone North America has issued a voluntary recall of over 75,000 bottles of International Delight coffee creamer following reports of product spoilage and illness. The ... Read More
Laplace Interventional advances life-saving heart valve technology with $22m funding round
Laplace Interventional, a Minnesota-based medical device company pioneering transcatheter tricuspid valve replacement technology, has secured $22 million in Series C financing to accelerate the development ... Read More
Sanofi advances flu vaccine production with FDA-approved strains for 2025-26 season
Sanofi has confirmed that it is advancing its flu vaccine production for the 2025-26 flu season, aligning with the US Food and Drug Administration (FDA)-selected ... Read More
AbbVie’s ELAHERE demonstrates 32% reduction in death risk for ovarian cancer patients
A final analysis of the Phase 3 MIRASOL trial has confirmed that ELAHERE (mirvetuximab soravtansine-gynx) provides a significant survival advantage for patients with folate receptor ... Read More
Dr. Reddy’s Laboratories recalls Levetiracetam Injection in U.S. over mislabeling concerns
Dr. Reddy’s Laboratories Limited has initiated a nationwide recall of a batch of Levetiracetam in 0.75% Sodium Chloride Injection, 1,000 mg/100 mL in the United ... Read More
Capricor Therapeutics advances deramiocel toward FDA approval with priority review
Capricor Therapeutics has reached a significant milestone in its efforts to develop a novel treatment for Duchenne muscular dystrophy cardiomyopathy. The U.S. Food and Drug ... Read More
Biocon Biologics reports positive Phase 3 results for Yesintek, biosimilar to Ustekinumab
Biocon Biologics Ltd., a global leader in biosimilar medicines and a subsidiary of India's pioneering biopharmaceutical giant Biocon Limited, announced promising results from its recent ... Read More
Longeveron 2024 revenue jumps 237%, eyes FDA approval for Lomecel-B
Longeveron Inc., a biotechnology company specializing in regenerative medicine, has reported significant financial progress alongside major advancements in its investigational stem cell therapy, Lomecel-B. The ... Read More
Breakthrough in kidney cancer imaging: FDA fast-tracks Telix Pharmaceuticals’ TLX250-CDx
The United States Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Telix Pharmaceuticals Limited’s investigational imaging agent, TLX250-CDx (Zircaix), granting ... Read More