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2915 News Found

Sun Pharma to commercialise Winlevi in the US and Canada
News | August 31, 2021

Sun Pharma to commercialise Winlevi in the US and Canada

Acne affects up to 50 million Americans annually. The last FDA approval of an acne drug with a new MOA occurred nearly 40 years ago


Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test
Drug Approval | August 30, 2021

Visby Medical receives FDA approval and CLIA waiver for PCR sexual health test

The Visby Medical sexual health click test is the first instrument-free PCR test for the detection of chlamydia, gonorrhoea and trichomonas, with results available within 30 minutes, during the patient visit


Union Minister Mansukh Mandaviya inaugurates Bharat Biotech’s Ankleshwar facility
News | August 29, 2021

Union Minister Mansukh Mandaviya inaugurates Bharat Biotech’s Ankleshwar facility

The facility has the capacity to produce one crore doses per day


Indian National Institute validates Livinguard’s face mask
Drug Approval | August 28, 2021

Indian National Institute validates Livinguard’s face mask

Textiles treated with the technology have also been proven to deactivate viruses, including SARS-CoV-2 (the virus that causes COVID-19).


European Commission grants market authorisation for BioMarin’s Voxzogo
Biotech | August 28, 2021

European Commission grants market authorisation for BioMarin’s Voxzogo

It is estimated that over 11,000 children across Europe, Middle East, and Africa are affected by achondroplasia and could be eligible for treatment with Voxzogo


U.S. FDA approves drug-free VNS system for stroke
Drug Approval | August 28, 2021

U.S. FDA approves drug-free VNS system for stroke

When used alongside rehabilitative exercise, this device may offer benefit to those who have lost function in their upper limbs due to ischemic stroke


Marksans announces US FDA approval for Acetaminophen Extended- Release tablets
News | August 27, 2021

Marksans announces US FDA approval for Acetaminophen Extended- Release tablets

The company will manufacture the products at its US FDA approved oral dosage facility at Goa in India


Brazil’s Eurofarma to manufacture Comirnaty for Latin America
Biotech | August 27, 2021

Brazil’s Eurofarma to manufacture Comirnaty for Latin America

The manufacture of finished doses will commence in 2022 and at full operational capacity, the annual production is expected to exceed 100 million doses annually


Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose
Drug Approval | August 26, 2021

Pfizer and BioNTech initiate rolling submission for Comirnaty booster dose

The submission to the US FDA has been initiated and they intend to file these data with the European Medicines Agency and other regulatory bodies in the coming weeks


Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin
Drug Approval | August 26, 2021

Wockhardt and Jemincare partner for novel respiratory antibiotic Nafithromycin

The company to receive upfront and milestone payments, in addition to royalties