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July 05, 2023
FDA has approved Roctavian (valoctocogene roxaparvovec-rvox), a gene therapy from BioMarin Pharmaceutical for treating severe hemophilia A in adults.
July 02, 2023
Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.
The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.
Problems continue despite actions by regulators to better prevent and address drug shortages.
FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.
The debate surrounding drug pricing changes rages on.
June 30, 2023
UCB’s rozanolixizumab-noli is approved for treatment of generalized myasthenia gravis in certain adult patient groups.
June 29, 2023
FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.
The persistent poverty initiative aims to fight the cumulative effects of persistent poverty on cancer outcomes.
June 26, 2023
FDA’s new draft guidance outlines key considerations for psychedelic drug development programs.