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Results For "Food-and-Drug-Administration"

1261 News Found

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment
Drug Approval | December 06, 2025

Merck Animal Health wins FDA’s fast-track green light for first-in-decades cattle parasite treatment

The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation


Granules’ packaging facility in US completes FDA inspection with zero observations
News | December 05, 2025

Granules’ packaging facility in US completes FDA inspection with zero observations

Granules Consumer Health serves as Granules’ front-end division for OTC products in the US


Lupin receives FDA’s tentative approval for Siponimod tablets
Drug Approval | December 05, 2025

Lupin receives FDA’s tentative approval for Siponimod tablets

Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis


Senores Pharmaceuticals receives Philippine FDA approval for 10 products
Drug Approval | December 05, 2025

Senores Pharmaceuticals receives Philippine FDA approval for 10 products

Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region


FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment
Drug Approval | December 04, 2025

FDA expands nod of Eli Lilly’s Jaypirca for earlier CLL/SLL treatment

Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor


Merck unveils first human data for Alzheimer’s candidates
Clinical Trials | December 03, 2025

Merck unveils first human data for Alzheimer’s candidates

The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration


Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt
Clinical Trials | December 03, 2025

Celltrion gets Health Canada nod for Eylea biosimilar Eydenzelt

Health Canada’s approval was based on a comprehensive evaluation of analytical, nonclinical, and clinical data


FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich
Drug Approval | December 02, 2025

FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA


Lupin receives FDA approval for biosimilar Armlupeg
Biotech | December 01, 2025

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs


Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI
Drug Approval | November 29, 2025

Biocon Biologics' Drug Substance Facility in Bengaluru cassified as VAI

This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States