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

134 News Found

Hyderabad startup’s Physiotherapy monitoring device ‘Pheezee’ receives USFDA
Medical Device | 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


Briefs: Biocon, Laurus Labs and Smruthi Organics
Drug Approval | February 13, 2023

Briefs: Biocon, Laurus Labs and Smruthi Organics

Laurus Labs has announced that the USFDA completed inspection of the formulations manufacturing facility Unit-2, APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh.


Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US
News | January 28, 2023

Dr. Reddy's Laboratories launches Difluprednate Ophthalmic Emulsion 0.05% in US

The Durezol brand and generic had US sales of approximately US $40 million MAT for the most recent twelve months ending in Nov 2022 according to IQVIA


Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr
News | January 24, 2023

Syngene Q3FY23 revenue reaches Rs. 803 Cr; PAT reaches Rs. 110 Cr

The company is pleased to report positive performances from all divisions this quarter. Growth in our research divisions, Discovery Services and the Dedicated Centres was solid