The US Food and Drug Administration has approved a new personalised medicine for HER2 positive breast cancer from Roche. But supplies of the drug will be limited pending the resolution of a manufacturing problem, according to the agency.
The US Food and Drug Administration has approved Horizant (gabapentin enacarbil) for the management of postherpetic neuralgia in adults. This follows the drug’s approval in the US in 2011 for restless legs syndrome.
Ridaforolimus, an investigational treatment for metastatic soft tissue or bone sarcoma, has been turned down by the US Food and Drug Administration. The sponsor, Merck & Co Inc, announced receipt of a complete response letter on 5 June 2012.
The European Medicines Agency (EMA) has launched a new public website that contains information about suspected adverse events relating to medicines that have been authorised for sale in the European Economic Area (EEA).
An advisory panel of the US Food and Drug Administration has recommended that the agency approve tofacitinib, a JAK inhibitor which has been developed to treat rheumatoid arthritis. A formal decision is expected in August, according to Pfizer.
The US Food and Drug Administration has approved the antibacterial medicine, Levaquin (levofloxacin), for the treatment of patients with plague, a rare disease that is estimated to affect up to 2,000 people per year.
The US Food and Drug Administration is asking farmers and veterinarians to restrict their use of antibiotics in food-producing animals in a further step towards protecting the effectiveness of currently marketed antibiotic medicines.
Dapagliflozin, a treatment for Type 2 diabetes that has been co-developed by AstraZeneca Plc and Bristol-Myers Squibb Company, has been recommended for approval in Europe. In January, the same drug was turned down by the FDA.
SkyePharma Plc’s asthma treatment, Flutiform, has been given a positive opinion by the European Medicines Agency’s Committee for Medicinal Products for Human Use. This brings the drug one step closer to a marketing authorisation in Europe.
Eric Abadie, the chair of the European Medicines Agency’s Committee for Medicinal Products for Human Use, has resigned and the agency’s executive director, Guido Rasi, has accepted the resignation with immediate effect, the EMA said.