Drug Approval | March 27, 2024
FDA approves Merck’s WINREVAIR for treatment of pulmonary arterial hypertension
WINREVAIR is a breakthrough biologic for this rare, progressive disease
WINREVAIR is a breakthrough biologic for this rare, progressive disease
Clinical findings support the safety and efficacy of BMND08 at a maximum dosage of 12mg
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
Merck to pay Daiichi Sankyo a $4 billion upfront payment in addition to $1.5 billion in continuation payments over the next 24 months
The company has submitted marketing authorization applications for mRNA-1345 with the European Medicines Agency (EMA), Swissmedic in Switzerland, and the Therapeutic Goods Administration (TGA) in Australia
Application being reviewed under the FDA Project Orbis framework, which enables concurrent reviews among US, Australia, Canada, Switzerland, Singapore and United Kingdom health authorities
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
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