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Results For "2025"

1246 News Found

Dr. Reddy’s secures first-mover advantage with FDA review of Orencia biosimilar
Clinical Trials | February 23, 2026

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


Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer
Drug Approval | February 20, 2026

Johnson & Johnson bags FDA nod for monthly RYBREVANT FASPRO dosing in advanced lung cancer

This approval builds on the recent transformation RYBREVANT FASPRO brought to lung cancer care


Dr Reddy’s enters hormone replacement therapy market with landmark brand acquisition
News | February 19, 2026

Dr Reddy’s enters hormone replacement therapy market with landmark brand acquisition

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


Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg
Drug Approval | February 19, 2026

Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension


LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system
News | February 18, 2026

LEX Diagnostics gets FDA nod and CLIA waiver for ultra-fast VELO system

The VELO system supports multiplex testing for Influenza A, Influenza B, and COVID-19, producing PCR results in six to ten minutes


Newron Pharmaceuticals bags up to €38 million to fuel Phase III ENIGMA-TRS program
Biopharma | February 18, 2026

Newron Pharmaceuticals bags up to €38 million to fuel Phase III ENIGMA-TRS program

A final tranche of €12 million will follow, contingent on positive pivotal study results, with the share price calculated according to an agreed formula


Novartis’ Vanrafia shows promise in slowing kidney decline in IgA nephropathy
Clinical Trials | February 17, 2026

Novartis’ Vanrafia shows promise in slowing kidney decline in IgA nephropathy

Vanrafia, a potent endothelin A receptor antagonist, received accelerated approval in the US and China in 2025 for reducing proteinuria in adults with IgAN


STADA & Bio-Thera bag European nod for Gotenfia
Drug Approval | February 16, 2026

STADA & Bio-Thera bag European nod for Gotenfia


Agilent’s PD-L1 test gains FDA nod for ovarian cancer
News | February 16, 2026

Agilent’s PD-L1 test gains FDA nod for ovarian cancer

This approval represents the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx with KEYTRUDA