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Results For "US-Food-and-Drug-Administration"

98 News Found

Lantern Pharma leverages AI platform to develop breakthrough ADCs with Bielefeld University
Digitisation | June 09, 2023

Lantern Pharma leverages AI platform to develop breakthrough ADCs with Bielefeld University

Lantern is receiving an exclusive and worldwide option to license intellectual property from Bielefeld University related to the collaboration and IP generated from the collaboration


European Commission authorises GSK’s Arexvy for older adults
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


Novartis receives European approval for Cosentyx
Drug Approval | June 03, 2023

Novartis receives European approval for Cosentyx

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


USFDA approves GSK’s respiratory syncytial virus vaccine ‘Arexvy’
Drug Approval | May 12, 2023

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


Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Equipment | May 05, 2023

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
Drug Approval | May 04, 2023

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
Drug Approval | May 04, 2023

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.


FDA approves Merck’s Keytruda in combination with Padcev for treatment of metastatic urothelial cancer
Drug Approval | April 04, 2023

FDA approves Merck’s Keytruda in combination with Padcev for treatment of metastatic urothelial cancer

First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients


MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine
News | March 30, 2023

MPP signs sublicences with Aurobindo, Cipla and Viatris to produce generic versions of HIV prevention medicine

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


Briefs: Piramal Pharma, Alembic Pharmaceuticals
News | February 17, 2023

Briefs: Piramal Pharma, Alembic Pharmaceuticals

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