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…
Citing declining lymphocyte and T-cell counts in some patients, Merck has stopped its phase 2 trial of a dual-agent HIV antiretroviral regimen and is probing similar studies for this concerning…
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…
There aren’t enough drugs under development to treat antibacterial and antifungal infections in patients with limited treatment options, even though the FDA offers a particular pathway to help expedite such…
After a long night which saw a vote on the Build Back Better Act delayed for many hours, the House of Representatives on Friday morning finally passed the nearly $2…
Within hours of the FDA authorizing booster doses of the Pfizer and Moderna COVID-19 vaccines for all adults, a Centers for Disease Control and Prevention (CDC) expert panel unanimously supported…