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The European Medicines Agency (EMA) recommended 92 medicines for authorization by the European Commission in 2021, 53 of which had a new active substance that had not been authorized in the EU before. Read More
An FDA inspection of Regeneron Pharmaceuticals’ active pharmaceutical ingredient (API) manufacturing facility in Rensselaer, N.Y., turned up observations of lapses in recordkeeping and cleaning procedures. Read More
Sanofi and GlaxoSmithKline (GSK) will very soon be taking their COVID-19 vaccine candidate to U.S. and European regulators as both a primary series and booster, touting its 58 percent efficacy against symptomatic disease as proof that the shot works in a world with multiple COVID-19 variants. Read More
Endo Pharmaceuticals’ Symmetrel is also used to treat symptoms of Parkinson’s disease and Parkinson’s-like symptoms caused by certain medications. Read More
The approval comes after a phase 3 trial of 5,674 patients in which Kerendia resulted in lower risks of CKD progression and cardiovascular events. Read More
The European Medicines Regulatory Network announced yesterday that it has adopted a common standard for the electronic product information (ePI) on medicines in the EU. Read More
FDA’s Office of Prescription Drug Promotion (OPDP) has issued a warning letter to precision medicine developer CytoDyn about a video interview found on the company’s corporate website. Read More
The FDA has announced that it found four lots of AstraZeneca COVID-19 vaccine drug substance manufactured at the troubled Emergent BioSolutions manufacturing facility in Baltimore, Md., to be acceptable for use for potential export. Read More
Homology Medicines’ phenylketonuria (PKU) gene therapy study is on clinical hold while the company investigates abnormalities in liver enzymes in patients who received the treatment, which is delivered by a viral vector. Read More