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3838 News Found

FDA completes inspection of SMS Pharma’s Vizag facility
Drug Approval | December 14, 2025

FDA completes inspection of SMS Pharma’s Vizag facility

The inspection concluded with one minor observation in Form 483


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


Merck wins key EU backing to expand use of PAH Drug WINREVAIR
News | December 13, 2025

Merck wins key EU backing to expand use of PAH Drug WINREVAIR

WINREVAIR is currently the first and only activin signalling inhibitor approved for PAH across all 27 EU member states


Grace and Molecule.one strike multi-year AI pact to break peptide manufacturing bottlenecks
Digitisation | December 13, 2025

Grace and Molecule.one strike multi-year AI pact to break peptide manufacturing bottlenecks

These building blocks are essential to modern therapeutics, including fast-growing GLP-1 treatments for weight loss and diabetes


Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain
News | December 12, 2025

Lupin Manufacturing Solutions partners with PolyPeptide to scale global peptide supply chain

This partnership strengthens LMS as a leading CDMO supplier of peptide materials for both innovator and generic markets


Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe
News | December 12, 2025

Shilpa Medicare receives initial authorization for Rotigotine transdermal patch from Europe

This is the first approval of a prescription transdermal dosage Form in the European markets from this facility


Senores Pharmaceuticals launches of Deferiprone Tablets USP, 500 mg & 1000 mg
News | December 12, 2025

Senores Pharmaceuticals launches of Deferiprone Tablets USP, 500 mg & 1000 mg

The product will be marketed by Dr. Reddy's Laboratories Inc.


Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial
News | December 12, 2025

Glenmark Pharmaceuticals USA to launch Leucovorin Calcium for Injection USP, 350 mg/vial single-dose vial

Glenmark's Leucovorin Calcium for Injection USP, 350 mg/vial Single-Dose Vial is bioequivalent and therapeutically equivalent to the reference listed drug


Roche bags CE Mark for automated mass spectrometry antibiotics monitoring
News | December 12, 2025

Roche bags CE Mark for automated mass spectrometry antibiotics monitoring

The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics