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An FDA advisory committee voted 9-4 yesterday in favor of Ardelyx’s Xphozah (tenapanor) for adults with chronic kidney disease (CKD) who are on dialysis, despite some concerns over the drug’s efficacy. Read More
The settlement, if approved, will resolve the defendants’ alleged abuse of the generic pharmaceutical approval process under the Hatch-Waxman Act. Read More
Pfizer has picked up three allies in its legal battle to continue a financial support program that provides cash to help patients buy its extremely expensive heart medication, tafamidis. Read More
The Biden administration has asked a federal judge to dismiss claims that the FDA has intentionally delayed rendering a decision on a Florida proposal to import prescription drugs from Canada. Read More
The decision follows an FDA review of the final overall survival analysis of the phase 3 trial for the drug, which showed no risk reduction compared to the control treatment. Read More
The Oregon Attorney General has filed a lawsuit accusing four pharmaceutical companies of filing sham lawsuits to prevent competitors from bringing a lower-priced generic version of their drug to market. Read More
In response to requests for a later deadline, the FDA has granted more time to comment on a pair of long-awaited proposed rules on institutional review board (IRB) reviews and informed consent requirements for clinical trials, pushing back the deadline until Dec. 28. Read More
The FDA has asked GSK to restrict its second-line maintenance indication for its ovarian cancer drug Zejula (niraparib) to patients with deleterious or suspected deleterious germline BRCA mutations, maintaining approval for the drug’s first-line indication. Read More
The Federal Trade Commission (FTC) has filed an amicus brief in the U.S. District Court for the District of Delaware arguing that some branded drug manufacturers have a history of using restricted distribution programs to delay the introduction of generic drugs. Read More