Drug Approval | January 24, 2024
Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union
Growth team leads financing round in Cleveland Diagnostics; company to advance novel blood-based diagnostic technology to improve and lower costs for patients with cancer
GMP certification helps enable biotechnology customers to accelerate accessibility of new RNA-based therapies for patients
The receipt of this permission paves way for the launch of Andexanet alfa powder for solution for infusion 200 mg (Andexxa) in India
Produodopa is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
Febuxostat Tablets (RLD Uloric) had estimated annual sales of US$ 27 million in the U.S. (IQVIA MAT November 2023)
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