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
Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets
Glenmark Life Sciences will manufacture API in the therapeutic area of urinary anti-spasmodic, to supply to the global innovator
Pimavanserin is an atypical antipsychotic indicated for the treatment of hallucinations and delusions associated with Parkinson disease psychosis
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
PharmaLogic will assist ARTBIO with radiochemistry and supply of the finished radiopharmaceutical product for future Phase I and II clinical trials of AB001 from their facility in New York
The R&D centre is mainly dedicated to the Process R&D of New Chemical Entities (NCE) development projects
Doxazosin tablets are indicated for the treatment of hypertension, to lower blood pressure
Bromfenac Ophthalmic Solution, 0.07% is the generic equivalent of Prolensa Ophthalmic Solution, 0.07%, of Bausch & Lomb
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