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Results For "FDA"

1778 News Found

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


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


Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024
Biotech | September 25, 2024

Biocon Biologics announces new dermatology data to be presented at EADV Congress 2024

These clinical studies support the interchangeability of adalimumab-fkjp at low-concentration with high-concentration adalimumab and ustekinumab biosimilarity


WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines
Diagnostic Center | September 23, 2024

WHO endorses Roche’s dual-stain cytology testing in its cervical cancer prevention guidelines

Roche’s CINtec PLUS Cytology is the only FDA-approved and CE-marked dual-stain test to triage human papillomavirus (HPV)-positive cervical cancer screening test results


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


Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis
Drug Approval | September 19, 2024

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids


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


Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh
Policy | September 14, 2024

Global Bio India unveils 30 breakthrough startups: Dr. Jitendra Singh

India's bio economy has experienced remarkable growth, skyrocketing from US $10 billion in 2014 to over $130 billion in 2024, with projections to reach $300 billion by 2030