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Results For "FDA"

2187 News Found

GSK’s experimental lung cancer drug gains FDA orphan drug status
Drug Approval | December 12, 2025

GSK’s experimental lung cancer drug gains FDA orphan drug status

GSK holds exclusive global rights (excluding mainland China, Hong Kong, Macau, and Taiwan) from Hansoh Pharma to advance its development and commercialization


FDA fast-tracks first drug nod under new national priority voucher program
News | December 12, 2025

FDA fast-tracks first drug nod under new national priority voucher program

The approval of Augmentin XR, granted to USAntibiotics, directly supports the CNPV program’s goals


FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034
News | December 12, 2025

FDA nods spotlight precision oncology platforms as market surges towards $212 billion by 2034

The U.S. oncology market is projected to soar from $81 billion in 2025 to $212 billion by 2034


Teva files FDA application for once-monthly schizophrenia injection
Drug Approval | December 11, 2025

Teva files FDA application for once-monthly schizophrenia injection

The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time


Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags
News | December 09, 2025

Caplin Steriles gets FDA final approval for Acetaminophen Injection, infusion bags

Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older


Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier
Healthcare | December 08, 2025

Bengaluru healthtech firm Biomoneta secures USFDA nod for air purifier

Captured microbes are then neutralized on engineered microbicidal surfaces


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


Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma
Drug Approval | December 06, 2025

Bristol Myers Squibb secures FDA nod for Breyanzi in marginal zone lymphoma

The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population


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