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Cytokinetics’ omecamtiv mecarbil received an 8-3 thumbs-down from the FDA’s Cardiovascular and Renal Drugs Advisory Committee, with the majority agreeing that the risks of the myosin activator outweigh its benefits for treating patients with heart failure and reduced ejection fraction. Read More
The landmark Inflation Reduction Act (IRA) passed in August means good news for seniors who need insulin, but diabetics under age 65 are still waiting for relief as legislators, regulators and industry all work toward lowering the price of the life-sustaining drug. Read More
Japan’s Takeda is acquiring Nimbus Therapeutics subsidiary Nimbus Lakshmi and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858 in a deal worth up to $6 billion. Read More
Results of a Merck/Moderna collaboration are the first evidence of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial, according to the companies. Read More
An FDA inspection of Consolidated Chemical’s St. Louis, Mo., drug manufacturing facility from July 25 to Aug. 2 resulted in a Form 483 citing water leaks, lack of water testing, poor building condition and other lapses. Read More
Two potentially first-in-class small molecule oral agents induced complete remission in nearly 30 percent of patients with genetically induced leukemias generally associated with very poor prognoses, according to reports from the American Society of Hematology (ASH) Annual Meeting in New Orleans. Read More