FDA Fast Tracks Glaxo’s Late-Stage Ovarian Cancer Candidate July 5, 2019 The FDA’s response to the application is due on Oct. 24. Read More
FDA Expands Botox Label July 1, 2019 The agency is reviewing a separate application to expand Botox’ label for lower limb spasticity. Read More
European Commission Approves Pfizer’s Breast Cancer Treatment July 1, 2019 Talzenna doubled the overall response rate compared to patients in the chemo group, Pfizer said. Read More
AMAG Wins Approval for Women’s Sex Drive Injection July 1, 2019 The drug has potent side effects and it prevents the body from absorbing the anti-opioid rescue drug naltrexone into the bloodstream. Read More
AveXis Gains Priority Review for Rare Pediatric Disorder Drug June 28, 2019 The disease saps the physical strength of patients until they are eventually unable to walk, eat or breathe. Read More
FDA Approves Cystic Fibrosis Combo Drug for Children Six and Up June 28, 2019 The expanded approval for children as young as six years old provides more context on the safety and dosing specific to this population. Read More
Gene Therapy Candidate Upends Diabetes Care—But at What Cost? June 17, 2019 Washington is outraged at the cost of medicines and the price of insulin is seen as exhibit A. Read More
Eli Lilly Pleads for Invalidated Cialis Patent in Supreme Court June 17, 2019 In 2017, the U.S. District Court ordered Lilly to pay $20 million in damages for patent infringement. Read More
Genentech Wins Accelerated Approval for Chemoimmunotherapy June 14, 2019 The agency previously granted Polivy breakthrough therapy, priority review and orphan drug status. Read More
FDA Approves New Combo Therapy for Kidney Cancer May 22, 2019 Patients who took the combination averaged five more months of progression-free survival. Read More
Lilly Wins Approval for Liver Cancer Treatment May 22, 2019 The approval comes after Lilly handed up results from a Phase 3 trial. Read More
Anixa Biosciences Earns Patent for CAR-T Cancer Therapy April 26, 2019 The technology use hormone-hormone receptor biology to address malignancies. Read More