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The European Medicines Agency’s (EMA) human safety medicines committee signed off on four new drugs during its monthly meeting held from April 19 to 22, including Novartis’ (capmatinib) for treating advanced nonsmall-cell lung cancer. Read More
Abaco Partners, operating as Surefil, has received a seven-observation Form 483 from the FDA after a November 2021 inspection of the company’s Grand Rapids, Mich., manufacturing facility turned up observations of testing and other quality lapses. Read More
The FDA announced Friday that it’s working on a project to identify and prioritize pharmaceutical quality (PQ) and chemistry and manufacturing and controls (CMC) information that would benefit from a structured submission approach. Read More
Scynexis said two phase 3 studies of its antifungal drug, ibrexafungerp, showed the drug’s efficacy against difficult-to-treat drug-resistant fungal infections. Read More
The World Health Organization (WHO) has issued a “strong recommendation” for Pfizer’s oral antiviral Paxlovid for mild and moderate COVID-19 in people at highest risk of hospitalization, such as unvaccinated, older or immunosuppressed patients. Read More
The company is seeking approval for the vaccine from the FDA, the European Medicines Agency and the UK’s Medicines and Healthcare products Regulatory Agency. Read More
The FDA’s latest annual report on the postmarket performance of drug and biologics firms, which covers the fiscal year Oct. 2, 2019, to Sept. 30, 2020, says 75 percent of the 816 unique postmarket requirements (PMRs) and postmarket commitments (PMCs) in the FDA’s system were on schedule. But the agency said many of the studies failed to file timely reports. Read More