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4212 News Found

GEA, JGC commission new spray dryer at Chugai Pharmaceutical in Japan
News | August 31, 2025

GEA, JGC commission new spray dryer at Chugai Pharmaceutical in Japan

This PSD-3, the first pharmaceutical spray dryer built by GEA for OEB-5 products, sets new standards for high-containment pharmaceutical spray drying


Apitoria Pharma receives 5 observations from USFDA for API facility
Drug Approval | August 31, 2025

Apitoria Pharma receives 5 observations from USFDA for API facility

At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported


Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China
News | August 30, 2025

Accro Bioscience and Fosun Pharma ink agreement for TYK2/JAK1 Inhibitor in Greater China

Accro will retain global rights to develop, manufacture, and commercialize AC-201 (excluding Chinese Mainland, Hong Kong SAR, and Macau SAR)


FDA approves Teva Pharmaceuticals' first GLP-1 obesity drug
Drug Approval | August 29, 2025

FDA approves Teva Pharmaceuticals' first GLP-1 obesity drug

Generic Saxenda is the first-ever generic GLP-1 indicated for weight loss, addressing increased demand for this category of therapies in the US market


Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension
News | August 29, 2025

Piramal Pharma Solutions supports George Medicines in developing new drug for hypertension

WIDAPLIK is the first and only FDA-approved triple combination medication for use as an initial therapy in patients likely to need multiple drugs to achieve blood pressure goals


Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra
Policy | August 27, 2025

Indian pharma resilient to US tariffs; Eyes US pricing reform gains: Ind-Ra

The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion


SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services
News | August 27, 2025

SMS Pharmaceuticals receives EIR from USFDA for Central Laboratory Analytical Services

The inspection, conducted from June 23 to June 25, 2025, concluded with zero Form 483 observations


Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection
Drug Approval | August 26, 2025

Gland Pharma receives FDA approval for Vasopressin in 5% Dextrose RTU Injection

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited