Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites

USFDA approves Astellas' Veozah’ for treatment of vasomotor symptoms due to menopause

VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause

USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’

Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time

Briefs: Dr. Reddy's Laboratories

USFDA has issued Form 483 with one observation

Zydus receives final approval from the USFDA for Sucralfate Tablets USP, 1 gram

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA

Pheezee is designed to assess musculoskeletal and neuromuscular health.

USFDA puts on hold Sun Pharma trials on dermatological drug

Sun Pharma said had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients