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December 05, 2017
Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.
December 04, 2017
FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.
December 02, 2017
New gene therapies and combination products require innovative regulatory approaches.
November 20, 2017
The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.
November 16, 2017
Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.
November 14, 2017
The agency approved Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication.
November 10, 2017
Two of the medicines recommended for approval are orphan drugs.
The EMA’s Committee for Medicinal Products for Human Use has recommended marketing authorization approval for AstraZeneca’s benralizumab, a monoclonal antibody for treating severe asthma.
The company expects to commercially launch the new vaccine in the US in the first quarter of 2018.
November 09, 2017
FDA is exploring ways to keep branded drug companies from using REMS to block the development of generic drugs.