News | December 12, 2025
FDA fast-tracks first drug nod under new national priority voucher program
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals
The Phase 3 HER2CLIMB-05 trial showed a 35.9% reduction in risk for patients treated with TUKYSA
The FDA aims to make a decision by April 8, 2026
The new centre brings advanced corneal procedures pioneered in India
The cobas Mass Spec solution Ionify reagent portfolio now covers therapeutic drug monitoring for immunosuppressants and antibiotics
At the trial’s pre-specified interim analysis, giredestrant achieved a hazard ratio of 0.70, marking a statistically significant improvement in invasive disease-free survival
The product will be marketed by Dr. Reddy's Laboratories Inc.
The Phase 2 study tested two dose levels of pumitamig alongside four standard chemotherapy regimens across first
Roche says its new assay “resolves this challenge by delivering accurate and specific results
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
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