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1542 News Found

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC
News | June 07, 2025

Linerixibat new drug application accepted for review by the USFDA for cholestatic pruritus in patients with PBC

If approved, linerixibat could address high unmet medical need of patients living with cholestatic pruritus (relentless itch) and related sleep interference


Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy
News | June 06, 2025

Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy

Simplified storage and administration of new tablet formulation may provide greater freedom and independence for people with Spinal Muscular Atrophy (SMA)


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
Diagnostic Center | 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


Revvity introduces new IVD reference standards for monitoring oncology diagnostic testing workflows
News | June 02, 2025

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


Pfizer’s Braftovi combination regime reduces death risk  for patients with  BRAF V600E mutant mCRC
Diagnostic Center | May 31, 2025

Pfizer’s Braftovi combination regime reduces death risk for patients with BRAF V600E mutant mCRC

Pivotal results from the Phase 3 Breakwater trial showed 51% risk reduction in death compared to standard-of-care treatment


Sudeep Pharma acquires Nutrition Supplies Services
News | May 30, 2025

Sudeep Pharma acquires Nutrition Supplies Services

This strategic move positions Sudeep Pharma to seamlessly integrate high-end premix capabilities with its mineral portfolio


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


Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP
Drug Approval | May 24, 2025

Alembic Pharmaceuticals announces USFDA final approval for Amlodipine and Atorvastatin Tablets USP

Amlodipine and Atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin