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5119 News Found

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


Aptus Pharma enters into urology therapy segment
News | November 24, 2025

Aptus Pharma enters into urology therapy segment

The company will soon be launching a new portfolio of products in this segment


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


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


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


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


BioNxt secures Eurasian patent for breakthrough sublingual MS therapy
News | November 24, 2025

BioNxt secures Eurasian patent for breakthrough sublingual MS therapy

The Eurasian Patent Organization (EAPO) has granted Patent, protecting the company’s sublingual delivery technology for anticancer drugs used to treat autoimmune and neurodegenerative diseases


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


Cosmo and Glenmark receives market authorization of Winlevi in Europe
News | November 23, 2025

Cosmo and Glenmark receives market authorization of Winlevi in Europe

Winlevi is authorized in EU for the treatment of acne vulgaris