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4236 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


Thermo Fisher Scientific appoints Anoopa Menon as Director
People | December 14, 2025

Thermo Fisher Scientific appoints Anoopa Menon as Director

In her previous roles, Menon led significant digital transformation efforts, implementing predictive analytics, automation


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


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


Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO
Clinical Trials | December 12, 2025

Suven Life Sciences achieved 100% patient enrolment in Phase-2b clinical trial of Ropanicant for MDO

The Phase-2b study is a randomized, double-blind, placebo-controlled trial that will enroll approximately 195 patients across 35 sites in the USA


GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization


FDA fast-tracks first drug nod under new national priority voucher program
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


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


Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma
Drug Approval | December 12, 2025

Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma

The FDA aims to make a decision by April 8, 2026