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973 News Found

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru
Drug Approval | June 17, 2025

USFDA conducts GCP inspection at Syngene's facility at Semicon Park, Bengaluru

The inspection concluded successfully, with the facility found to be in compliance with the required regulations


Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease
News | June 16, 2025

Roche to advance prasinezumab into Phase III development for early-stage Parkinson's disease

Prasinezumab is a potential first-in-class anti-alpha-synuclein antibody, targeting a known biological driver of Parkinson’s disease progression


USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad
Drug Approval | June 13, 2025

USFDA inspection at the API manufacturing plant located in Mekaguda, Hyderabad

The company received 1 (One) observation in the Form-483


Biocon Foundation launches BioWISE Program to empower women in STEM
News | June 11, 2025

Biocon Foundation launches BioWISE Program to empower women in STEM

25 women students to receive internship, training, and mentorship in Life Sciences segment


Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer
Clinical Trials | June 02, 2025

Arvinas and Pfizer's Vepdegestrant significantly improves progression-free survival for patients with ESR1-Mutant, ER+/HER2- advanced breast cancer

Vepdegestrant is the first and only PROteolysis TArgeting Chimera (PROTAC) evaluated in a Phase 3 clinical trial and the first to show benefit in patients with breast cancer


Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer
News | May 31, 2025

Merck’s MK-1084 shows antitumor activity in Phase 1 trial of patients with advanced colorectal cancer

Manageable safety profile and encouraging antitumor activity observed for MK-1084 in KANDLELIT-001, both as a monotherapy and in studied combinations


Merck withdraws Biologics License Application for Patritumab Deruxtecan
Drug Approval | May 30, 2025

Merck withdraws Biologics License Application for Patritumab Deruxtecan

The decision to withdraw the BLA is based on topline overall survival (OS) results from the confirmatory HERTHENA-Lung02 Phase 3 trial where OS did not meet statistical significance


Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor
News | May 29, 2025

Pimicotinib demonstrates best-in-class potential with significant efficacy and clinically meaningful improvements in patients with tenosynovial giant cell tumor

MANEUVER met all five key secondary endpoints, with statistically significant and clinically meaningful improvements in pain, stiffness, range of motion, physical function, and decrease in tumor volume