USFDA approves next-gen TKI Augtyro for treatment of solid tumors

Augtyro is the only FDA-approved treatment option for NTRK-positive tumors studied in both TKI-naïve and TKI-pretreated patients across solid tumors

USFDA approves expanded age indication for GSK’s RSV vaccine ‘Arexvy’

Over 13 million US adults aged 50-59 years have a medical condition that increases their risk of severe RSV outcomes

Farxiga approved in the US for the treatment of paediatric type-2 diabetes

Approval based on results from T2NOW, one of the largest paediatric type-2 diabetes Phase III trials to date

AxoSim appoints Alif Saleh as CEO

Co-founder and previous CEO Lowry Curley becomes Chief Scientific Officer

Suven to acquire a majority stake in CDMO player ‘Sapala Organics’

Sapala has a strong customer base including innovator Pharma, CDMOs & diagnostic companies

USFDA inspection of Lupin’s Nagpur injectable facility with zero 483 observations

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace

Ecolab and Repligen launch DurA Cycle affinity resin for biologic manufacturing

DurA Cycle is designed for large-scale commercial manufacturing of monoclonal antibodies,

Briefs: Dr. Reddy's Laboratories and Ami Organics

Dr. Reddy's Laboratories gets Form 483 from USFDA with 4 observations for API facility