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.
FDA approval of Pfizer subsidiary Wyeth’s Rapamune for lymphangioleiomyomatosis may be the light at the end of the tunnel for sufferers of the extremely rare lung disease. Read More
While nearly three-quarters of generic drugs saw prices fall in 2013, the 27 percent that saw price increases led to the smallest average annual decline in seven years, a new report finds. Read More
The FDA on Wednesday approved Patheon Pharmaceuticals’ Viberzi and Salix Pharmaceuticals’ Xifaxan for the treatment of irritable bowel syndrome with diarrhea in adult patients. Read More
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
The FDA’s Drug Safety Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committees will meet jointly in early July to discuss whether postmarket studies of reformulated OxyContin extended-release tablets show reduced misuse and abuse of the blockbuster pain reliever. Read More
Cephalon has agreed to pay the federal government $1.2 billion to settle antitrust allegations that it illegally blocked competition to Provigil by paying generics makers to hold off on their versions of the blockbuster narcolepsy drug. Read More
The FDA is working on a new bioinformatic approach to evaluating the sameness of a generic drug’s active ingredient compared with that of the reference product. Read More
The FDA’s Drug Safety Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committees will meet jointly in early July to discuss whether postmarket studies of reformulated OxyContin extended-release tablets show reduced misuse and abuse of the blockbuster pain reliever. Read More