The White House’s Office of Science and Technology Policy has issued a memo directing federal agencies with R&D spending to publicly share the findings and data from government-funded research as…

The FDA levied import alerts on 49 manufacturing sites in fiscal year 2021 for refusing inspections or records requests, noncompliant laboratory testing and noncompliant findings from inspections and records requests…

FDA Commissioner Robert Califf highlighted the role the biomedical “ecosystem” should play in reversing the decline in life expectancy in the U.S. in a Science magazine editorial last week. Source:…

Novartis announced that it intends to spin off Sandoz as a fully independent company in a move that could be completed in the second half of next year. Source: Drug…

Paxlovid, Pfizer’s oral antiviral drug to treat COVID-19, offers little or no benefit for adults between age 40 and 65, according to a large study in Israel. Source: Drug Industry…

Combined with talk therapy, two strong doses of psilocybin – the active chemical of “magic mushrooms” – reduced heavy drinking by 83 percent, significantly more than when subjects just had…

The number of drug manufacturing facilities registered with the FDA has grown by an average of 3 percent worldwide since 2018, according to the FDA Office of Pharmaceutical Quality’s 2021…

Pfizer will ask the FDA to approve its respiratory syncytial virus vaccine, RSVpreF, based on phase 3 data showing that it prevented about 86 percent of severe disease. Source: Drug…

Controversy often arises around FDA’s drug approval decisions when the system fails to produce reliable evidence of risks and benefits, says FDA Commissioner Robert Califf, alluding to recent criticism of…

The FDA issued a warning letter to Tramadol US, calling on the company to stop selling prescription drugs, including opioids, directly to consumers on the 25 websites the company operates.…