We'll skip an introduction this week to save room for dessert, but suffice to say that several sponsors have something to be thankful for after US FDA approvals.
Keeping Track Of Approvals: Cancer, Cancer, And A Two-Week Cancer Review
The latest drug development news and highlights from our US FDA Performance Tracker.
More from Approvals
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The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
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Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
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Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
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Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
More from Product Reviews
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The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
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Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
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The European Medicines Agency’s qualification of the AIM-NASH tool is said to signify a major advancement for clinical trials for metabolic dysfunction-associated steatohepatitis. The market size for MASH treatments is expected to grow substantially in the coming years.