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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 sponsors. Read More
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. Read More
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. Read More
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 patients with untreated unresectable or metastatic urothelial cancer. Read More
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 “hypothyroidism, including hair loss, extreme fatigue, painful sensitivity to temperature changes and debilitating hives.” Read More
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 late-stage study. Read More