FDA
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A week into his tenure as head of the FDA’s Center for Drug Evaluation and Research, experts agree that Rick Pazdur is the “ideal fit” to stabilize the agency. And, according to one ex-FDA official, if his CBER counterpart Vinay Prasad tries to supersede Pazdur’s authority, “there will be hell to pay.”
Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
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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.
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.