Drug Approval | June 08, 2023
European Commission authorises GSK’s Arexvy for older adults
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time
European approval is based on robust Phase III data showing Cosentyx provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1,3-5
Ground-breaking approval enables adults aged 60 years and older to be protected from RSV disease for the first time
Pheezee is designed to assess musculoskeletal and neuromuscular health.
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 expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.
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