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…
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…
Scynexis said two phase 3 studies of its antifungal drug, ibrexafungerp, showed the drug’s efficacy against difficult-to-treat drug-resistant fungal infections. Source: Drug Industry Daily
Three new research and licensing partnerships — including one acquisition — were announced late last week. Source: Drug Industry Daily
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,…
The FDA’s Center for Drug Evaluation and Research (CDER) released a final guidance yesterday on drugs and biologics that contain nanomaterials, noting that the agency has not yet established regulatory…
U.S. spending on drugs shot up by 12 percent in 2021 — climbing to $407 billion — due to increased use of COVID-19 vaccines and therapeutics, says a new analysis…
The FDA’s Oncologic Drugs Advisory Committee voted nearly unanimously (16 for and one abstaining) to require makers of phosphatidylinositol 3-kinase (PI3K) inhibitors in blood cancers to complete randomized phase 3…
Evusheld, AstraZeneca’s dual-antibody injection, reduced the risk of COVID-19 by more than 76 percent at three months and by 83 percent at six months after immunization, new trial results show.…
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…