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Johnson & Johnson (J&J) announced it has received an approvable letter from the FDA regarding a new drug application (NDA) for paliperidone extended-release (ER) tablets for the treatment of schizophrenia.
Nastech Pharmaceutical announced it has submitted a complete response to the not approvable letter from the FDA for its abbreviated new drug application (ANDA) for a generic nasal treatment for osteoporosis.
The FDA said it has been conducting a safety review of Bayer's Trasylol(aprotinin injection), which is used to reduce blood loss during some types of heart surgeries, since January.
Alpharma has announced positive results from a Phase II multidose clinical efficacy and pharmacokinetic trial for its abuse-deterrent, extended-release opioid.
Wyeth Pharmaceuticals has presented data from Phase III studies of Tygacil in patients with community-acquired pneumonia (CAP), which is defined as pneumonia not acquired in a hospital or long-term care
facility.
Centocor announced that the FDA has approved Remicade (infliximab) for the treatment of adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.
Eli Lilly announced it is weighing options for the further development of ruboxistaurin mesylate in light of a request by the FDA for an additional three-year, Phase III trial to support the company's new drug application (NDA).