Briefs: J B Chemicals and Pharmaceuticals, Concord Biotech and Gland Pharma

J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA

Datroway approved in the US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

First and only TROP2-directed therapy approved in the US for the treatment of lung cancer

UFlex introduces FSSAI compliant single-pellet solution for food packaging

UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials

Briefs: Hikal and Sun Pharma

Sun Pharma gets 8 observations from USFDA for Halol facility

Zydus receives EIR for the API manufacturing facility at Ankleshwar and Dabhasa

Zydus receives EIR for the API manufacturing facility at Ankleshwar

Allarity announces enrolment of first patient in phase 2 clinical trial protocol of Stenoparib in advanced ovarian cancer

The newly launched protocol will accelerate the clinical development of stenoparib and its drug-specific Drug Response Predictor (DRP) companion diagnostic (CDx) toward potential FDA approval

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

Keytruda plus Trodelvy reduced risk of disease progression by 35% V/s Keytruda plus cchemothrapy in first-line PD-L1+ TNBC

First pivotal Phase 3 trial to show superiority of Keytruda plus a TROP2 antibody-drug conjugate, Trodelvy, versus standard of care in first-line metastatic TNBC

SeQuent–Viyash merger receives stock exchange approvals; NCLT filing underway

Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows

Revvity launches its first set of IVD Mimix reference standards, providing diagnostic labs with trusted quality controls for optimizing tests and monitoring workflows