The certification follows an inspection conducted by the Malta Medicines Authority between January 29, 2026, and February 3, 2026
Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States
The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy
The approval enables the company to directly sell health insurance plans to individuals and families while integrating its managed healthcare delivery model into retail offerings
Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million
Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders
Approval for generic Ozempic® in Canada strengthens OneSource’s global CDMO footprint in complex peptide injectable manufacturing
Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market
Q2 2026 analysis shows expanding approvals, stronger uptake, and a shift toward evidence-driven biosimilar evaluation
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)
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