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1369 News Found

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg
Drug Approval | June 02, 2025

Zydus receives tentative approval from USFDA for Rifaximin Tablets, 550 mg

Rifaximin tablets had annual sales of US$ 2672.9 mn in the United States (IQVIA MAT March 2025)


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


Paras Health Gurugram raises alarm over surge in tobacco-related cancers
News | May 31, 2025

Paras Health Gurugram raises alarm over surge in tobacco-related cancers

Approximately 35% of male cancer patients and 12% of female cancer patients at Paras Health were diagnosed with tobacco-related cancers


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


Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer
Drug Approval | May 29, 2025

Bayer’s Sevabertinib granted FDA priority review for the treatment of patients with HER2-mutant non-small cell lung cancer

This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition


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


Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK
News | May 26, 2025

Biocon Biologics receives MHRA, UK approval for biosimilar YESINTEK

YESINTEK is indicated for the treatment of adults and children from the age of 6 years and olde


GlaxoSmithKline Pharmaceuticals posts FY25 PAT at Rs. 915 Cr
News | May 14, 2025

GlaxoSmithKline Pharmaceuticals posts FY25 PAT at Rs. 915 Cr

The Board of Directors of the company recommends a final dividend of Rs. 42 per equity share for the 12 months period ended March 31, 2025


Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity
News | May 13, 2025

Lupin launches Tolvaptan Tablets in the US with 180-day exclusivity

Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease


Zydus receives final approval from USFDA for Glatiramer Acetate Injection
Drug Approval | May 12, 2025

Zydus receives final approval from USFDA for Glatiramer Acetate Injection

Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes