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The FDA issued over-the-counter (OTC) drug and cosmetic manufacturer Allure Labs a four-observation Form 483 following a November to December 2021 inspection of its Hayward, Calif., facility, noting procedural lapses and possible underreporting of deviations, nonconformances and out-of-specification (OOS) events. Read More
A group of generic drugmakers pledged to manufacture versions of Pfizer’s COVID-19 antiviral pill Paxlovid (nirmatrelvir/ritonavir) for use in the developing world and agreed to price them at $25 or less per treatment course. Read More
UCB drew a Complete Response Letter (CRL) from the FDA rejecting the company’s Biologics License Application (BLA) for its investigational monoclonal antibody drug bimekizumab in adult patients with moderate-to-severe plaque psoriasis. Read More
The companies “have inflated the price of insulin and other diabetes-related medication to line their own pockets,” said Arkansas Attorney General Leslie Rutledge. Read More
In the wake of a controversial court ruling affecting orphan drug pricing, Sens. Bill Cassidy (R-La.) and Tammy Baldwin (D-Wisc.) this week introduced legislation that would codify orphan drug exclusivity protections. Read More
A recent FDA warning letter to Brigham and Women’s Hospital cites the Boston, Mass., drug manufacturing facility for lack of aseptic conditions observed during an inspection from August through September 2021. Read More
In the wake of strongly positive data and an FDA go-ahead, Veru will seek an Emergency Use Authorization (EUA) for sabizabulin, its investigational COVID-19 therapy. Read More