The approved Lacosamide Oral Solution is bioequivalent and therapeutically equivalent to the reference drug and will be manufactured at Indoco’s facility in Verna Industrial Area, Goa
The therapy was well tolerated through Week 24, with a safety profile consistent with Alumis’ Phase 2 data
The trial’s primary endpoint is the mean change in HbA1c from baseline, while secondary endpoints include changes in fasting blood glucose, body weight, and overall safety
The company is pursuing the accelerated FDA 505(b)(2) approval pathway for its once-daily oral ondansetron formulation
The approval introduces a needle-free alternative to injectable GLP-1 therapies
CLE, a common form of lupus erythematosus, primarily causes diverse skin lesions
The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ENV-6946 in healthy volunteers
Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial
Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia
Takeda said zasocitinib was generally well tolerated, with a safety profile consistent with earlier studies
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