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10133 News Found

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga
News | December 15, 2025

Indoco receives EIR from the USFDA for its API manufacturing facility at Patalganga

Indoco received the Establishment Inspection Report from the USFDA for its API manufacturing facility


Caplin Point Laboratories’ injectables facility completes INVIMA audit successfully
Drug Approval | December 15, 2025

Caplin Point Laboratories’ injectables facility completes INVIMA audit successfully

This is also an important milestone in our product strategy for our expansion into the larger Latin American market


Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide
News | December 14, 2025

Biocon Biologics strikes deal to sell its version of the eye drug Aflibercept worldwide

All pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed


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


Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer
Clinical Trials | December 12, 2025

Pfizer’s TUKYSA shows major benefit in first-line maintenance for metastatic breast cancer

The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA


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


Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma
News | December 12, 2025

Formation Bio snaps up global rights to next-gen CNS TYK2 inhibitor from Lynk Pharma

LNK01006 is designed to deliver potent, selective inhibition of TYK2-mediated cytokine signaling with central nervous system exposure


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