A federal judge has overturned a $4.5 billion settlement that protected members of the Sackler family, owners of Purdue Pharma, the maker of OxyContin. Source: Drug Industry Daily
The FDA’s fall 2021 regulatory agenda includes several new proposed and final rules. Source: Drug Industry Daily
The FDA announced that it will loosen longstanding restrictions on mifepristone, known as the abortion pill, making it easier to get just as the Supreme Court seems poised to curtail…
Adults infected with the Omicron variant are 29 percent less likely to enter the hospital than people infected with other COVID-19 strains, according to the first large-scale real-world clinical data.…
Adults in the U.S. should get the Pfizer or Moderna COVID-19 vaccine and booster rather than the Johnson & Johnson (J&J) jabs. Source: Drug Industry Daily
The FDA offered advice on designing a visual inspection program to ensure injectable drugs are free of visible particulates in a new draft guidance released yesterday, noting that automated inspections…
There are almost 800 drugs for rare diseases either in clinical trials or awaiting review by the FDA, according to a new report by the Pharmaceutical Research and Manufacturers of…
AstraZeneca’s COVID-19 vaccine becomes completely ineffective against the Omicron variant by 15 weeks, according to real-world British data released yesterday. Source: Drug Industry Daily
Calliditas Therapeutics’ Tarpeyo (budesonide) has won FDA accelerated approval for reducing a harmful urine protein in adults with a rare kidney disease, primary immunoglobulin A (IgA) nephropathy. Source: Drug Industry…
Stanton, Calif.-based Sanitor Corporation has drawn an FDA warning letter over current good manufacturing practice (cGMP) violations for finished drugs. Source: Drug Industry Daily