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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The recommended dose of the drug for this age group is based on weight and liver function.
The U.S. Food and Drug Administration approved Abbott’s molecular test for the novel coronavirus that causes COVID-19 under an Emergency Use Authorization.
The U.S. Food and Drug Administration granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata.
Hospitals and laboratories will be able to run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are already in wide use in the U.S. and internationally.
Recipharm, a leading contract development and manufacturing organisation, is pleased to note the FDA’s approval of Perrigo’s AB-rated generic of ProAir HFA.
Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population.
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s Ofev (nintedanib) for patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
Novartis’ Isturisa (osilodrostat) was approved for adults with Cushing’s disease who either can’t have pituitary gland surgery or who have had the surgery but still have the disease.
Although March looks to be a busy month for the U.S. Food and Drug Administration, several of the PDUFA dates for this week were for drugs under Priority Review.
Glaucoma is a progressive disease of the eye that can lead to irreversible vision loss and blindness.