All articles by Swagath Bandhakavi
Swagath Bandhakavi
Novo Nordisk’s STEP UP trial meets primary endpoint with semaglutide 7.2mg
Participants on semaglutide 7.2mg achieved 20.7% weight loss, surpassing 17.5% with semaglutide 2.4mg and 2.4% with placebo
Junshi Biosciences announces toripalimab’s approval in Australia
Toripalimab has become the first and only immuno-onocology treatment for NPC in Australia
Acadia Pharmaceuticals submits EMA marketing application for trofinetide in Rett Syndrome
Filing marks company’s first marketing authorisation application in Europe
Humacyte secures FDA approval for bioengineered vascular conduit SYMVESS
The bioengineered vascular conduit is intended for adults with extremity arterial injuries, offering a solution for urgent revascularisation to prevent limb loss when vein grafts are unavailable
EC grants approval to GSK’s fully liquid Menveo vaccine for invasive meningococcal disease
GSK stated that the fully liquid presentation streamlines the vaccination process, offering greater convenience for healthcare providers
AOP Orphan’s Rapiblyk gets FDA approval for supraventricular tachycardia
The approval includes the use of Rapiblyk for managing atrial fibrillation and atrial flutter in critical care settings within hospitals
SELLAS announces positive data from preclinical studies indicating ASXL1 mutations as predictor of response to SLS009 in solid cancers
Preselection method for cancers responding to SLS009: High efficacy of SLS009 observed in 67% of ASXL1 mutated solid cancers vs 0% in non-ASXL1 mutated cancers
FDA accepts Dupixent resubmission for review in chronic spontaneous urticaria treatment
The application aims to secure approval for the treatment of adults and paediatric patients aged 12 years and above with chronic spontaneous urticaria that is not adequately managed by H1 antihistamines
Syndax secures FDA approval for Revuforj to treat R/R acute leukaemia
The FDA approved Revuforj based on Phase 1/2 AUGMENT-101 trial data, which showed a 21% combined remission rate in 104 patients with R/R acute leukaemia
Merck receives positive EU CHMP opinion for Keytruda plus chemotherapy in unresectable non-epithelioid MPM
Opinion granted based on positive overall survival results from the IND.227/KEYNOTE-483 trial