Dirt floating in so-called sterile vials and other serious quality lapses led the FDA to hit sterile drug manufacturer Toyobo of Otsu, Japan, with an 11-observation Form 483. Source: Drug…
Did former FDA Commissioner Stephen Hahn cave to political pressure from the Trump Administration in authorizing hydroxychloroquine and convalescent plasma as treatments for COVID-19 even though there was scant evidence…
More than 40 percent of patients in pivotal phase 3 trials of Aduhelm (aducanumab), Biogen’s FDA-approved Alzheimer’s treatment, experienced either brain swelling or microhemorrhages associated with the now-approved 10 mg/kg…
Public Citizen has called on the FDA to take strong action against two Minneapolis, Minn., investigators and the institutional review board (IRB) at Hennepin County Medical Center (HCMC) over investigational…
Dercher Enterprises of Upper Darby, Pa., doing business as Gordon Laboratories, was hit with an eight-observation Form 483, and the company’s new quality director told FDAnews that he’s working to…
Indian Generics Maker Sun Pharma Recalls ED Meds in the U.S. Source: Drug Industry Daily
The two-dose Pfizer-BioNTech COVID-19 vaccine regimen was 100 percent effective in preventing disease in children aged 12-15 years, the companies reported. Source: Drug Industry Daily
The FDA issued an update yesterday on its inspection performance for fiscal 2021, indicating that it had surpassed its projections for completed inspections by more than 30 percent due to…
The FDA has closed out its three-year-old warning letter to Zhejiang Huahai Pharmaceutical’s site in Linhai, Taizhou because of corrective actions the manufacturer has undertaken. Source: Drug Industry Daily
The UK’s National Institute for Clinical Evidence (NICE) has given a thumbs-up to the first dual-agent injectable HIV-1 treatment for use by the National Health Service (NHS). Source: Drug Industry…