Drug Approval | December 12, 2025
Apitoria Pharma receives 3 observations from USFDA for Unit-V
The company will respond to the US FDA within the stipulated timelines
The company will respond to the US FDA within the stipulated timelines
The investigational therapy uses SteadyTeq, a proprietary copolymer technology from Medincell designed to release olanzapine steadily over time
Acetaminophen Injection is indicated for the management of mild to moderate pain in adult and pediatric patients 2 years and older
Alport Syndrome is caused by genetic mutations affecting type IV collagen in the kidneys, ears, and eyes
The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation
Granules Consumer Health serves as Granules’ front-end division for OTC products in the US
Siponimod Tablets is indicated for the treatment of relapsing forms of multiple sclerosis
Senores Pharmaceuticals is poised to accelerate its presence in the Asia-Pacific region
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
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