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Results For "Phase-II"

570 News Found

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults
Drug Approval | December 24, 2025

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo


Bayer wins Japan nod for finerenone in broad heart failure population
Drug Approval | December 23, 2025

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients


FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer
Drug Approval | December 23, 2025

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care


Ipsen’s FALKON trial falls short in rare FOP study, offers key insights
Clinical Trials | December 22, 2025

Ipsen’s FALKON trial falls short in rare FOP study, offers key insights

FOP is a rare genetic disorder caused by mutations in the ALK2 kinase


GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year
Drug Approval | December 20, 2025

GSK’s Exdensur gains FDA nod for severe asthma with just two doses a year

The approval for Exdensur (depemokimab-ulaa) comes on the back of SWIFT-1 and SWIFT-2 Phase III trials


Takeda joins BaseLaunch to boost early-stage biotech ventures in Europe
News | December 19, 2025

Takeda joins BaseLaunch to boost early-stage biotech ventures in Europe

BaseLaunch has supported 27 biotech companies across multiple modalities and indications


Lupin receives positive CHMP opinion for biosimilar Ranibizumab
Drug Approval | December 18, 2025

Lupin receives positive CHMP opinion for biosimilar Ranibizumab

Ranibizumab is a recombinant humanized IgG1 monoclonal antibody fragment that binds to and inhibits vascular endothelial growth factor A


Anil Koul joins Mankind Pharma as Group Chief Scientific Officer
People | December 15, 2025

Anil Koul joins Mankind Pharma as Group Chief Scientific Officer

More than five drug candidates from his team progressed to human trials including drugs like Rilematovir (Phase IIb), and Bedaquiline


EMA backs Eylea 8 mg for retinal vein occlusion
News | December 13, 2025

EMA backs Eylea 8 mg for retinal vein occlusion

The positive CHMP opinion is supported by results from the Phase III QUASAR trial


New oral SERD from Roche delivers significant survival edge in early breast cancer
Clinical Trials | December 12, 2025

New oral SERD from Roche delivers significant survival edge in early breast cancer

At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival