Food and Drug Administration (FDA)
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MorphoSys AG announced that the U.S. Food and Drug Administration accepted filing of MorphoSys’ Biologics License Application and granted priority review for tafasitamab, the Company’s investigational anti-CD19 antibody, under review in combination with lenalidomide for the treatment of relapsed or refractory diffuse large B cell lymphoma.The FDA has set a Prescription Drug User Fee Act goal date of August 30, 2020.
This approval marks the first time in a decade Sanofi has had a wholly-owned cancer drug approved.
Five years after Martin Shkreli rose to infamy for acquiring the toxoplasmosis treatment Daraprim from Impax Laboratories for $55 million and then jacking the price by 5,000%, the U.S. FDA approved the first generic for the medication.
The green light from the U.S. Food and Drug Administration marks the first approval for U.K.-based Acacia.
Nexlizet is expected to be on the market in the U.S. in July 2020.
The agency has identified approximately 20 drugs whose active ingredients or finished products are solely sourced in China.
The FDA is reviewing the sNDA under the Real-Time Oncology Review (RTOR) pilot program, which could speed up the process for potential approval.
Seqirus snagged approval for Fluad Quadrivalent, the first-and-only quadrivalent adjuvanted influenza vaccine developed to help protect adults 65 years and older against seasonal influenza.
H. Lundbeck A/S is making a statement with its newly approved treatment for migraine, the first intravenous medication approved for the preventative treatment of migraine.
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