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8464 News Found

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients
Drug Approval | November 24, 2025

FDA nod to groundbreaking bladder cancer combo therapy for surgery patients

Call it a major milestone in bladder cancer therapy that aims to provide a lifeline for patients who previously had limited options


Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla
Drug Approval | November 24, 2025

Shilpa Medicare receives 8 observations from USFDA for Unit 4 at Jadcherla

The Unit is approved by major regulators like EMA, Europe; Health Canada, Anvisa, Brazil and TGA, Australia


FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures
News | November 24, 2025

FDA slaps gene therapy Elevidys with boxed warning after fatal liver failures

Elevidys came under scrutiny in June when the FDA disclosed two fatal cases in non-ambulatory boys who developed dangerously high liver enzyme levels


Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy
News | November 24, 2025

Texas hits Sanofi, Bristol-Myers Squibb with lawsuit over blood thinner drug efficacy

Paxton alleges the companies marketed Plavix as a reliable defense against heart attacks, strokes, and blood clots while failing to disclose evidence that the drug could be ineffective or virtually useless for many people


Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab
News | November 24, 2025

Dr Reddy’s receives EU nod for AVT03 biosimilar denosumab

AVT03 is a biosimilar of Amgen's Prolia (denosumab 60 mg/mL) and Xgeva (denosumab 70 mg/mL), which are used to treat various bone conditions


Ind-Swift Laboratories receives certifications from Bureau Veritas
Sustainability | November 24, 2025

Ind-Swift Laboratories receives certifications from Bureau Veritas

These certifications reflect the company's continuous commitment to maintaining international standards of environmental sustainability as well as occupational health and safety


Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD
Clinical Trials | November 24, 2025

Mesoblast teams with NIH to launch pivotal trial of life-saving cell therapy in adults with severe aGvHD

The therapy -- Ryoncil (remestemcel-L-rknd) -- will be tested in adults with severe steroid-refractory acute graft-versus-host disease


Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi
Drug Approval | November 24, 2025

Alvotech and Advanz Pharma secure European nod for Gobivaz, first biosimilar to Simponi

Gobivaz is authorised for adults with rheumatoid arthritis (in combination with methotrexate), psoriatic arthritis (with or without methotrexate), axial spondyloarthritis, and ulcerative colitis


Rafa Laboratories lands $186 million BARDA contract to develop life-saving trauma drug
R&D | November 23, 2025

Rafa Laboratories lands $186 million BARDA contract to develop life-saving trauma drug

Landmark studies have shown that rapid TXA administration can significantly reduce mortality


FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients
Drug Approval | November 23, 2025

FDA approves combo therapy for Cisplatin-ineligible muscle-invasive bladder cancer patients

The approvals target adult MIBC patients who are ineligible for cisplatin-based chemotherapy