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Depomed announced that it has completed enrollment in a Phase II clinical trial to evaluate its Gabapentin GR compound for the treatment of patients with painful diabetic peripheral neuropathy (DPN).
New data presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy indicate that nearly all treatment-experienced HIV patients who initiated therapy with Fuzeon (enfuvirtide) and the investigational integrase inhibitor MK-0518 in a clinical trial achieved undetectable levels of HIV (less than 400 copies per mL of blood).
US WorldMeds announced that it is enrolling patients in a Phase III clinical trial, USWM-001, investigating the use of lofexidine hydrochloride (Lofexidine) for the treatment of opiate withdrawal symptoms in opiate dependent individuals.
Schering AG and Biogen Idec have announced the start of the Zevalin (ibritumomab tiuxetan) in aggressive lymphoma (ZEAL) trial, a Phase III, international multicenter clinical study.
The FDA has approved a new indication for one of the leading prescription antipsychotic medications, Risperdal (risperidone), for the treatment of irritability associated with autistic disorder, including symptoms of aggression toward others, deliberate self-injuriousness, temper tantrums and quickly changing moods, in children and adolescents ages 5 to 16, Janssen has announced.
Merck announced that the FDA has approved oral Zolinza (vorinostat) 400 mg once daily for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL), a form of non-Hodgkin's lymphoma, who have progressive, persistent or recurrent disease during or following two systemic therapies.
Sepracor has announced that the FDA approved its new drug application (NDA) for Brovana (arformoterol tartrate) Inhalation Solution 15 micrograms as a long-term, twice-daily, maintenance treatment for broncho-constriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
Wyeth Pharmaceuticals announced it has initiated its global filing strategy for Torisel (temsirolimus) with the simultaneous submissions of a new drug application (NDA) to the FDA and a marketing authorization application (MAA) to the European Medicines Agency (EMEA).
Shire has announced that its collaborative partner New River Pharmaceuticals has received an approvable letter from the FDA for NRP104 (lisdexamfetamine dimesylate) for the treatment of pediatric attention-deficit/hyperactivity disorder (ADHD).