FDA approves Herceptin biosimilar as US patent expiresThe FDA has approved Amgen and Allergan’s biosimilar of Roche’s Herceptin, just in time for the breast cancer Share XFDA approves Herceptin biosimilar as US patent expireshttps://pharmaphorum.com/news/fda-approves-herceptin-biosimilar-as-us-patent-expires/
Catalyst squares up to FDA over rival drug approvalCatalyst Pharma is suing the FDA over its approval of a potential rival to its rare disease therapy Share XCatalyst squares up to FDA over rival drug approvalhttps://pharmaphorum.com/news/catalyst-squares-fda-rival-drug-approval/
Motif pummelled as FDA asks for more data on antibioticShares in UK biotech Motif Bio fell more than 50% after its much-delayed antibiotic was held up at Share XMotif pummelled as FDA asks for more data on antibiotichttps://pharmaphorum.com/news/motif-pummelled-as-fda-asks-for-more-data-on-antibiotic/
FDA rejects Heron’s non-opioid painkillerShares in US biotech Heron Therapeutics were sharply down yesterday after the FDA rejected its post-operative painkiller, saying Share XFDA rejects Heron’s non-opioid painkillerhttps://pharmaphorum.com/news/fda-rejects-herons-non-opioid-painkiller/
FDA rejects Nabriva’s antibiotic over manufacturing concernsThe FDA has rejected a proposed antibiotic from the Irish biotech Nabriva Therapeutics, citing concerns about manufacturing standards. Share XFDA rejects Nabriva’s antibiotic over manufacturing concernshttps://pharmaphorum.com/news/fda-rejects-nabrivas-antibiotic-over-manufacturing-concerns/
FDA approves first treatment for children with lupusThe US FDA has approved GSK’s Benlysta (belimumab) intravenous infusion for the treatment of children with lupus. While Share XFDA approves first treatment for children with lupushttps://pharmaphorum.com/news/fda-approves-first-treatment-children-lupus/
FDA approves first medical device ADHD treatmentUS regulators have given the green-light for the first medical device to treat attention deficit hyperactivity disorder (ADHD). Share XFDA approves first medical device ADHD treatmenthttps://pharmaphorum.com/news/fda-approves-neurosigma-adhd/
Zogenix slumps after FDA refuses epilepsy drug fileZogenix’s only drug candidate is facing a long delay after the FDA refused to accept its marketing application, Share XZogenix slumps after FDA refuses epilepsy drug filehttps://pharmaphorum.com/news/zogenix-slumps-after-fda-refuses-epilepsy-drug-file/
Real-world data unlocks Ibrance ok in male breast cancerThe FDA has expanded the use of Pfizer’s Ibrance to include use in breast cancer in men based Share XReal-world data unlocks Ibrance ok in male breast cancerhttps://pharmaphorum.com/news/real-world-data-unlocks-ibrance-ok-in-male-breast-cancer/
