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1661 News Found

Savara resubmits FDA application for potential treatment in rare lung disease patients
Biopharma | January 01, 2026

Savara resubmits FDA application for potential treatment in rare lung disease patients

The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer


Ultragenyx’s Setrusumab falls short in Phase 3 osteogenesis imperfecta trials
Clinical Trials | January 01, 2026

Ultragenyx’s Setrusumab falls short in Phase 3 osteogenesis imperfecta trials

The trials did not show a statistically significant reduction in annualized clinical fracture rates compared to placebo or bisphosphonates


Establishment Labs seeks FDA nod for Motiva breast reconstruction implants
News | January 01, 2026

Establishment Labs seeks FDA nod for Motiva breast reconstruction implants

Motiva, SmoothSilk, Round and Ergonomix implants represent the latest in plastic surgery innovation


WORK Medical scores regulatory approval for AI-powered blood analyzer
Medical Device | January 01, 2026

WORK Medical scores regulatory approval for AI-powered blood analyzer

It performs white blood cell differential counts and quantifies red blood cell and platelet morphology,


SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent
Clinical Trials | January 01, 2026

SOFIE Biosciences doses first patient in Phase 3 trial of novel cancer imaging agent

The study will run across 18 sites and enroll roughly 200 patients over 24 months


Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency
News | January 01, 2026

Wockhardt’s WCK 5222 earns accelerated review from European Medicines Agency

The accelerated review covers WCK 5222 for multiple critical infections


UK’s healthcare regulator warns against dangerous online weight-loss drugs
Public Health | December 31, 2025

UK’s healthcare regulator warns against dangerous online weight-loss drugs

Experts warn that illegal products may be fake, contaminated, incorrectly dosed, or contain powerful unlisted ingredients


CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers
Clinical Trials | December 31, 2025

CARsgen submits INDs for next-gen CAR-T therapy targeting hard-to-treat blood cancers

The applications aim to launch Phase Ib/II trials for relapsed/refractory multiple myeloma and primary plasma cell leukemia, respectively


Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance
Clinical Trials | December 31, 2025

Diamyd Medical accelerates Phase 3 Type 1 diabetes trial following FDA guidance

The interim efficacy readout, involving around 170 participants with 15-month data, remains on track for the end of March 2026


Transcenta teams up with EirGenix to revolutionise biologics manufacturing
News | December 31, 2025

Transcenta teams up with EirGenix to revolutionise biologics manufacturing

Transcenta will grant EirGenix a non-exclusive license to its Highly Intensified Continuous Bioprocessing (HiCB) platform