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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majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.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 01, 2017
In a recently released statement, FDA Commissioner Scott Gottlieb warned of an amino acids supply shortage and gave an update on a saline supply shortage, both due to the impact of hurricanes on Puerto Rican manufacturing facilities.
November 30, 2017
Experts slam drug prices and endorse government price negotiations and curbs on drug advertising.
November 27, 2017
Manufacturers and trading partners struggle to meet drug tracking requirements
The new guidelines discuss GMPs and patient protection specific to advanced therapy medicinal products.
November 21, 2017
Following a vote by member states in favor of Amsterdam as the agency’s new headquarters, the relocation will take place over the next 16 months, with operations expected to start up in March 2019.
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
Commissioner Scott Gottlieb issued a statement warning about the risks associated with kratom.