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Results For "USFDA"

1211 News Found

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria
News | December 22, 2024

Shilpa Medicare’s Unit VII, Nacharam, Hyderabad receives GMP certificate from EMA, Austria

The company has received the GMP Certification after successful closure of the inspection


ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility
Drug Approval | December 21, 2024

ANVISA inspection received from Brazil Health Regulatory Agency at Wanbury Tanuku facility

The company will receive GMP compliance certificate which will further help to accelerate the business growth across the globe


Granules India FDA approval for ADHD treatment
Drug Approval | December 17, 2024

Granules India FDA approval for ADHD treatment


Merck announces FDA acceptance of biologics license application for Clesrovimab
Drug Approval | December 17, 2024

Merck announces FDA acceptance of biologics license application for Clesrovimab

An investigational long-acting monoclonal antibody designed to protect infants from RSV disease during their first RSV season


Briefs: Alembic Pharmaceuticals and Veerhealth Care
Drug Approval | December 12, 2024

Briefs: Alembic Pharmaceuticals and Veerhealth Care

The successful completion of RRA assessment by the USFDA, would enable company to open up its business in the USA market


Gland Pharma receives approval for phytonadione injection emulsion
Drug Approval | December 12, 2024

Gland Pharma receives approval for phytonadione injection emulsion

This product is indicated in coagulation disorders caused by vitamin K deficiency or interference with vitamin K activity.


FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy
Drug Approval | December 07, 2024

FDA RMAT status for Affimed and Artiva’s lymphoma combo therapy

Designation was based on early efficacy data demonstrating an 83.3% (10/12) overall response rate and a 50% (6/12) complete response rate, with a well-managed safety profile in Relapsed/Refractory Hodgkin Lymphoma patients


Gland Pharma receives approval for Latanoprost Opthalmic Solution, 0.005%
Drug Approval | December 04, 2024

Gland Pharma receives approval for Latanoprost Opthalmic Solution, 0.005%

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xalatan


Dr. Reddy's launches Toripalimab in India
News | December 01, 2024

Dr. Reddy's launches Toripalimab in India

The first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma


FDA approves BridgeBio’s Attruby for ATTR-CM treatment
Biotech | November 26, 2024

FDA approves BridgeBio’s Attruby for ATTR-CM treatment

Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR