Latest News for: usfda

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Alembic Pharma gets USFDA nod to market generic anti-fungal solution

The Times of India 24 Feb 2026
The company has received ...
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USFDA clears Dr Reddy’s licence application for biosimilar to Orencia

Business Line 21 Feb 2026
The proposed drug is intended for the treatment of arthritis ....
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USFDA accepts for review Dr Reddy's biologics license application for Orencia biosimilar DRL_AB

The Times of India 21 Feb 2026
USFDA accepts for review Dr Reddy's biologics license application for Orencia biosimilar DRL_AB Swati Bharadwaj Hyderabad ... A pivotal Phase 3 study (AB-01-004) comparing the efficacy and safety of DRL_AB with Orencia is currently underway. .
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Zydus Lifesciences in focus after USFDA clears Ahmedabad plant, Aflibercept biosimilar launch

The Times of India 20 Feb 2026
Zydus Lifesciences is in focus after receiving USFDA clearance with zero ...
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Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable ...

Business Wire 20 Feb 2026
HYDERABAD, India--(BUSINESS WIRE)---- $RDY #Abatacept--Dr. Reddy’s announces USFDA acceptance to review its Biologics License Application (BLA) for proposed interchangeable biosimilar, Abatacept ... .
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Dr. Reddy’s Announces USFDA Acceptance to Review Its Biologics License Application (BLA) for Proposed Interchangeable Biosimilar, Abatacept

Pharmiweb 20 Feb 2026
Following the submission in December 2025, USFDA has accepted Dr ... Reddy’s”), today announced that the US Food and Drug Administration (USFDA) has accepted for review, its 351 (k) Biologics License ...
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Icon Group Deploys ChartCheck Adaptive Across Australia as Radformation Secures USFDA 510(k) Clearance

Enid News & Eagle 18 Feb 2026
NEW YORK & MELBOURNE, Australia--(BUSINESS WIRE)--Feb 18, 2026-- ... .
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USFDA issues Form 483 with 6 observations to Alkem subsidiary's Chakan plant

Business Line 16 Feb 2026
The company has achieved zero ...
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Alkem Labs' Chakan facility gets six observations in USFDA inspection, no data integrity issues

The Times of India 16 Feb 2026
... its subsidiary Enzene Biosciences received a Form 483 from the USFDA.
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USFDA issues Form 483 with 4 observations to Piramal Pharma's Telangana unit

Business Line 14 Feb 2026
The US Food and Drug ...
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DifGen Pharmaceuticals LLC Receives USFDA Approval for Fluorometholone Ophthalmic Suspension, 0.1% - Expanding Its Complex Generic Portfolio

PR Newswire 12 Feb 2026
Food and Drug Administration (USFDA) for its Fluorometholone Ophthalmic Suspension, 0.1% - a complex generic formulation used to treat eye inflammation. This is only the second generic USFDA approval of this complex suspension product.
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Zydus’ Desidustat gets USFDA orphan drug status for sickle cell disease

The Economic Times 06 Feb 2026
Zydus Lifesciences announced a significant development today ... .
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Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

The Economic Times 06 Feb 2026
... for Parkinson's disease, has been cleared by the USFDA.
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Strides Pharma's Chestnut Ridge unit in New York classified as voluntary action indicated by USFDA

The Times of India 05 Feb 2026
... has received a Voluntary Action Indicated classification from the USFDA.
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Natco Pharma gets USFDA nod for cancer generic drug

Business Line 03 Feb 2026
Natco’s Erdafitinib is approved for ...

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