Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
BLA is based on a robust data package supporting similarity to Orencia (abatacept) IV for infusion through totality of evidence including pharmacokinetic (PK) data
This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care
The acquisition marks the company’s strategic entry into the fast-growing Hormone Replacement Therapy (HRT) segment and significantly strengthens its gynaecology portfolio in India
Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension
The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes
A final tranche of €12 million will follow, contingent on positive pivotal study results, with the share price calculated according to an agreed formula
Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN
This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA
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