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Results For "ANDA"

2607 News Found

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1
Drug Approval | September 24, 2025

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated


Pharma Manufacturing & Automation Convention 2025 to be held on Oct. 8-9, 2025 in Hyderabad
News | September 24, 2025

Pharma Manufacturing & Automation Convention 2025 to be held on Oct. 8-9, 2025 in Hyderabad

Sessions will cover process mapping, cost optimisation, data-driven decision-making, cybersecurity, and sustainable manufacturing practices


Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer
Clinical Trials | September 23, 2025

Roche's Giredestrant combination meets phase III endpoints in advanced breast cancer

Importantly, the combination of giredestrant and everolimus was well tolerated


AllRock Bio raises $50 million to drive therapy for pulmonary hypertension into phase 2 trials
Clinical Trials | September 19, 2025

AllRock Bio raises $50 million to drive therapy for pulmonary hypertension into phase 2 trials

Funding supports development of first-in-class pan-ROCK inhibitor ROC-101 through Phase 2a clinical testing


FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations
Drug Approval | September 19, 2025

FDA completes inspection of Indoco’s API manufacturing facility at Patalganga with zero observations

The inspection concluded with zero form 483 observations


AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment
Clinical Trials | September 18, 2025

AstraZeneca's Saphnelo succeeds in Phase III as self-injectable lupus treatment

The TULIP-SC trial investigated the efficacy and safety of subcutaneous Saphnelo


Pete Pharma and FABRX announce strategic partnership
News | September 17, 2025

Pete Pharma and FABRX announce strategic partnership

Pete Pharma will leverage FABRX’s extensive foundation of scientific validation to deliver a commercially viable, pharmacy-ready solution in the US