The FDA formalized user fee assessment changes under the Generic Drug User Fee Act of 2017 (GDUFA) in a final guidance released yesterday, adding a new section on refunds to…

The FDA has removed a clinical hold it placed on Gilead Sciences’ experimental HIV-1 drug lenacapavir in December 2021 because of quality concerns about the drug’s borosilicate glass vials. Source:…

The FDA gave the generic antidepressant fluvoxamine a decisive thumbs-down as a treatment option for COVID-19 this week, only days after an influential independent nonprofit research panel recommended it. Source:…

The FDA has authorized a single booster of the Pfizer-BioNTech COVID-19 vaccine for children age five through 11 years. Source: Drug Industry Daily

The novel combination of albuterol and budesonide in AstraZeneca’s PT027 reduced the risk of severe asthma flare-ups by 27 percent in patients with moderate-to-severe asthma, according to results from a…

The FDA has approved Eli Lilly’s Mounjaro (tirzepatide) injection as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The approval marks the…

Acella Pharmaceuticals is facing a potential class action lawsuit in a federal court in Georgia that claims its NP Thyroid hormone replacement drug is “worthless” and left one patient with…

BridgeBio Pharma is offloading its rare pediatric disease priority review voucher (PRV) for $110 million to an undisclosed buyer. Source: Drug Industry Daily

Bristol Myers Squibb (BMS) said that its late-stage trial of Opdivo (nivolumab) plus Yervoy (ipilimumab) did not meet its goal of improving overall survival compared with standard-of-care treatment in certain…

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…