FDA
The FDA previously rejected Zycubo for Menkes disease in October last year, citing issues with the drug’s manufacturing facility.
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After a tumultuous year, experts call for stability while anticipating the first fruits of policies intended to expedite approvals for rare disease drugs.
The FDA’s announcement that it will phase out in vivo testing requirements for monoclonal antibodies marks a seismic shift. Here’s how industry can adapt.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
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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.
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.
The company is planning for its drug for cholesterol lowering medications to hit the streets by the end of March. It will provide a new option to all the patients.
The approval marks the first once-per-day 24-hour, intravenous COX-2 preferential NSAID, the company said.
Here’s a look at the two drugs that had dates this week but were approved early and are now on the market.
The U.S. Food and Drug Administration has a busy week planned for drug review. Here’s a look at this week’s schedule.