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The Senate Appropriations Committee unanimously approved a bill on Thursday that would provide a total of $5.2 billion for the FDA in fiscal 2018. Read More
The report recommends actions for the FDA and other federal agencies, as well as state and local governments and healthcare-related organizations. Read More
The European Commission issued a Statement of Objections to Teva over its 2005 “pay-for-delay” deal with Cephalon in which Teva agreed not to market a cheaper generic for Cephalon’s sleep disorder drug Provigil (modafinil). Read More
Takeda’s patent for its multiple myeloma drug Velcade was restored and extended for five more years after a federal appeals court overturned a district court ruling. Read More
The court ruled an Actavis product would infringe on Lilly’s patent for the Alimta vitamin regimen regardless of the diluent used in reconstitution or dilution. Read More
A Senate Appropriations subcommittee on Tuesday approved a bill that would provide $2.8 billion in discretionary funding for the FDA in fiscal 2018. Read More
FDA Commissioner Scott Gottlieb expanded on his drug competition action plan at a day-long agency meeting on generic competition Tuesday. To make the process more transparent, the agency is considering publicizing when it grants permission for brand-name companies to sell product samples of REMS-covered drugs to developers of generics. Read More