Apotex files suit to force approval of its Prilosec ANDA, which is being held up by Andrx' exclusivity. Suit charges that FDA improperly granted Andrx additional period of exclusivity for omeprazole 40 mg based on a late-filed patent.

Two of the leading medical journals are offering opposing viewpoints on mandatory human papilloma virus vaccination, with experts contributing perspective pieces that directly reflect the larger political and social division over the issue

FDA's "not approvable" action on Merck's Vioxx follow-on Arcoxia for the treatment of symptoms of osteoarthritis could be indicative of a conservative regulatory climate at the agency