All articles by Swagath Bandhakavi
Swagath Bandhakavi
CSL gets Japanese approval for Andembry in hereditary angioedema prevention
Andembry is Japan’s first fully human monoclonal antibody targeting activated Factor XII, a key trigger in the biochemical process that leads to angioedema episodes in HAE patients
FibroGen to divest China subsidiary to AstraZeneca in $160m deal
As part of the agreement, AstraZeneca will acquire full rights to roxadustat in China
Gilead’s seladelpar gets conditional European marketing authorisation in primary biliary cholangitis
Now approved, seladelpar can provide an important treatment option for people living with the rare liver disease in the European Economic Area
BridgeBio Pharma secures EC approval for Beyonttra in treatment of ATTR-CM
The approval is based on Phase 3 ATTRibute-CM trial results, showing acoramidis significantly reduced cardiovascular-related hospitalisations, improved survival, and preserved functional capacity in 632 patients with symptomatic ATTR-CM.
Linvoseltamab BLA accepted for FDA review for treatment of relapsed/refractory multiple myeloma
Acceptance follows resolution of third-party fill/finish manufacturing issues
FDA grants approval for Leqembi IV maintenance dosing in early Alzheimer’s treatment
Eisai and Biogen have announced FDA approval for a once-every-four-weeks maintenance dosing option for patients with early-stage Alzheimer’s disease
X4 Pharmaceuticals announces EMA validation of MAA for mavorixafor in WHIM syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial
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