We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Pay-for-delay deals “hurt consumers twice,” by delaying the introduction of cheaper generics and by stifling competition among multiple generics companies, the bill’s sponsor said. Read More
The agency said it will limit the approved use of Uloric to certain patients who experience side effects or don’t see effective treatment from allopurinol. Read More
The FDA’s Oncologic Drugs Advisory Committee voted 8 to 5 on Tuesday in favor of delaying the approval of Karyopharm Therapeutics’ NDA for selinexor, a multiple myeloma treatment, pending the results of a Phase 3 trial. Read More
The Senate Finance Committee quizzed senior executives from seven leading drugmakers on Tuesday, calling on them to justify the sky-high prices of their prescription drugs. Read More
In an October 2018 appeal, Maryland’s Attorney General Brian Frosh claimed the decision would limit states’ abilities to regulate drug prices. Read More
Pennsylvania drugmaker Lehigh Valley Technologies agreed to pay $4 million to settle allegations of a conspiracy to illegally evade paying NDA fees. Read More
Sponsors of bioavailability trials should be prepared to show that any differences in the rate or extent of absorption compared with an existing drug won’t affect the safety or efficacy of the candidate drug, the FDA said in a new draft guidance issued Monday. Read More