Drug Approval | August 06, 2025
AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
The submission is supported by positive results from the Phase 3 AMPLIFY trial
The submission is supported by positive results from the Phase 3 AMPLIFY trial
7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors
The submission is supported by results from the Phase 3b APEX study
Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug
The company received one observation in the Form-483
Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India
Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad
FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths
Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials
The company is addressing these observations comprehensively
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