Drug Approval | January 23, 2024
EMA grants ODD to GC Biopharma's treatment for Sanfilippo Syndrome
GC1130A has previously achieved notable milestones by securing both RPDD and ODD from the U.S. FDA in January 2023
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
Produodopa is the first-and-only subcutaneous 24-hour infusion of levodopa-based therapy for the treatment of severe motor fluctuations
Glenmark Life Sciences will manufacture API in the therapeutic area of urinary anti-spasmodic, to supply to the global innovator
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)
Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis
The bold, dynamic, and new logo unveiled in this process captures the essence of the 'Better Together' theme
The PAI was conducted for two drug product applications (ANDAs) filed from this facility
The certification underscores Venus Remedies Limited's adherence to stringent quality control measures
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