Drug Approval | 12 December 2025
Bristol Myers Squibb scores FDA priority review for Opdivo in advanced hodgkin lymphoma
The FDA aims to make a decision by April 8, 2026
The FDA aims to make a decision by April 8, 2026
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
The approval follows strong results from Roche’s phase II NOBILITY and phase III REGENCY studies
The topical fluralaner solution is cleared for the prevention and treatment of new world screwworm infestation
The one-time CAR T cell infusion now becomes the first and only therapy of its kind cleared for this patient population
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
Grant of Permission to manufacture and market FDC of Naproxen Delayed Release and Esomeprazole capsule (375mg/500mg + 20mg/20mg)
Jaypirca is the first and only FDA-approved non-covalent (reversible) BTK inhibitor
Here's a development that aims to keep your blood pressure in check. Literally!
This inspection was conducted following the warning letter issued by the USFDA
Presbyopia, the age-related loss of near vision, could soon be treated successfully
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
The FDA has classified recent submissions as a major amendment pushing the approval to its NDA for TransCon CNP back three months to February 28, 2026
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The audit was completed with zero critical and zero major observations
The approval by the US FDA comes after extensive safety testing and manufacturing improvements
The positive outcome clears the way for Glenmark to resume commercial manufacturing at the site
It's a development that marks a major step forward for patients struggling with moderate-to-severe chronic spontaneous urticaria
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