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The drug was approved in 2018 to treat X-linked hypophosphatemia (XLH), a rare form of rickets characterized by low levels of phosphate in the blood. Read More
The FDA has issued a direct-to-final guidance on using benzene in drug manufacture and has revised a recently issued draft guidance on topical ophthalmic drug quality, an area in which the agency has seen significant quality control issues recently. Read More
Coming back from a complete response letter (CRL) for its Udenyca Onbody drug device combo, Coherus BioSciences has received FDA approval of the product to decrease the incidence of febrile neutropenia after chemotherapy. Read More
This edition of Quick Notes highlights drug approvals from regulators in the U.S. and Europe, while confirming December so far has been a pretty good month for Astellas Pharma with several drug approvals in the U.S. and EU. Read More
Since both programs accept limited clinical evidence for investigational products, sponsors can establish specification acceptance criteria wider than the actual test results. Read More
As 2023 draws to a close, the FDA has issued several final guidances, including documents on collecting trial data with digital health technologies, developing rare disease drugs and biologics, and complying with a final rule on TV and radio prescription drug ads, as well as a new draft guidance on clinical trial master protocols. Read More
The FDA delivered a couple of unwelcome holiday gifts to two hopeful sponsors in the form of Complete Response Letters (CRL) — one for Merck’s chronic cough drug gefapixant and the second for Zealand Pharma’s dasiglucagon, an investigational agent intended to treat congenital hyperinsulinism. Read More
Bristol Myers Squibb’s (BMS) $14 billion acquisition of Karuna Therapeutics accelerates the company’s diversification into the neuroscience space with Karuna’s priority asset, KarXT (xanomeline-trospium), leading the way. Read More
Ultragenyx Pharmaceutical has agreed to pay $6 million to resolve allegations that it caused the submission of false claims to Medicare and Medicaid, according to the Department of Justice (DOJ). Read More
CDER has developed a new adaptive crossover trial design that can be used in demonstrating the bioequivalence (BE) of generic versions of drugs with high pharmacokinetic (PK) variability. Read More
A newly published Q&A document from the FDA and the European Medicines Agency (EMA) outlines the similarities — and differences — in the two agencies’ requirements for manufacturing breakthrough products. Read More