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Results For "USFDA"

1452 News Found

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777
Drug Approval | October 08, 2024

FDA grants fast track designation to Wockhardt's novel antibiotic WCK 6777

WCK 6777 is the only once-a-day drug in global antibiotic pipeline designed for outpatient parenteral antimicrobial therapy


Briefs: Aurobindo Pharma and Lupin
News | October 06, 2024

Briefs: Aurobindo Pharma and Lupin

USFDA completes PAI of Lupin’s biotech facility in Pune


Zydus receives EIR for the transdermal manufacturing facility
Drug Approval | October 02, 2024

Zydus receives EIR for the transdermal manufacturing facility

This facility underwent an inspection from 15th to 19th July 2024 and has been classified as Voluntary Action Indicated


Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir
News | October 02, 2024

Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


FDA approves Bristol Myers Squibb’s Cobenfy
Drug Approval | September 28, 2024

FDA approves Bristol Myers Squibb’s Cobenfy

A first-in-class muscarinic agonist for the treatment of schizophrenia in adults


Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD
Drug Approval | September 27, 2024

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype


Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals
Drug Approval | September 22, 2024

Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations


Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals
Drug Approval | September 20, 2024

Briefs: Dr. Reddy's Laboratories and Torrent Pharmaceuticals

USFDA concludes inspection of Dr. Reddy's Laboratories R&D centre in Bachupally with zero observation


Briefs: Eugia Steriles and Shelter Pharma
Drug Approval | September 18, 2024

Briefs: Eugia Steriles and Shelter Pharma

Eugia Steriles receives EIR from USFDA for new injectable facility