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Results For "FDA"

1722 News Found

Granules India receives ANDA approval for Trazodone Tablets
Drug Approval | August 11, 2024

Granules India receives ANDA approval for Trazodone Tablets

Trazodone tablets are indicated for the treatment of major depressive disorder in adults


Aurobindo posts Q1 FY25 PAT higher by 61% at Rs. 7,567 Cr
News | August 11, 2024

Aurobindo posts Q1 FY25 PAT higher by 61% at Rs. 7,567 Cr

Revenue from Operations increased by 10.5% YoY to Rs. 7,567 crore with growth across the businesses


Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr
News | August 10, 2024

Biocon posts Q1 FY25 PAT higher at Rs. 660 Cr

This strong performance was primarily on account of a one-time gain from the strategic collaboration between Biocon Biologics and Eris Lifesciences.


Gland Pharma posts 16% revenue growth in Q1 FY25
News | August 07, 2024

Gland Pharma posts 16% revenue growth in Q1 FY25

The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore


Lupin completes  successful Phase 3 trials for Lucentis biosimilar
Biotech | August 06, 2024

Lupin completes successful Phase 3 trials for Lucentis biosimilar

The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU


OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously
News | August 06, 2024

OneSource and BRL ink technology licensing agreement to deliver high-concentration biologics subcutaneously

Revolutionary technology will further boost OneSource’s scientific services offerings


European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion
Drug Approval | August 03, 2024

European Commission approves Roche’s Vabysmo for treatment of retinal vein occlusion

Approval is based on data from two Phase III studies in branch and central retinal vein occlusion (RVO) showing early and sustained vision improvements non-inferior to aflibercept


GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s  CHMP opinion for adults aged 50-59
Drug Approval | July 30, 2024

GSK’s RSV vaccine ‘Arexvy’ receives positive European Medicines Agency’s CHMP opinion for adults aged 50-59

Decision on EU marketing authorisation for this population expected by September 2024


Briefs: Indoco Remedies and Alembic Pharmaceuticals
Drug Approval | July 29, 2024

Briefs: Indoco Remedies and Alembic Pharmaceuticals

Indoco Remedies is addressing the observations comprehensively and will respond to the USFDA within the stipulated timeframe


Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate
Diagnostic Center | July 26, 2024

Pfizer announces positive topline results from Phase 3 study of hemophilia A gene therapy candidate

Giroctocogene fitelparvovec study meets primary and key secondary objectives of superiority compared to prophylaxis