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Regulation & Policy
FDA approves flu vaccine made with DNA technology
Thursday 17 January 2013
The US Food and Drug Administration has approved Flublok, the first trivalent influenza vaccine made from an insect virus expression system and recombinant DNA technology. The prophylactic vaccine has been approved for people from 18 to 49 years.
Location
United States
FDA approves new indication for Kineret
Friday 11 January 2013
Swedish Orphan Biovitrum AS (Sobi) has announced US Food and Drug Administration approval of its arthritis drug, Kineret (anakinra), for the treatment of children and adults with neonatal-onset multisystem inflammatory disease (NOMID).
Location
Sweden
FDA approves botanical drug to treat diarrhoea in HIV patients
Tuesday 1 January 2013
The US Food and Drug Administration has approved a botanical drug to relieve the symptoms of diarrhoea in HIV/AIDS patients taking antiretroviral therapy. The drug, Fulyzaq (crofelemer), is only the second botanical drug product to be approved by the agency.
Location
United States
FDA approves first drug for resistant TB
Tuesday 1 January 2013
The US Food and Drug Administration has authorised the first drug to treat multi-drug resistant tuberculosis involving the lungs in an accelerated approval based on a surrogate endpoint. The drug, Sirturo (bedaquiline), was discovered and developed by Johnson & Johnson Inc.
Location
United States
Safety review starts for Merck cardiovascular drug
Thursday 27 December 2012
The European Medicines Agency has announced the start of a safety and efficacy review of Tredaptive (laropiprant and nicotinic acid), a licensed drug that recently completed a trial in combination with statin therapy for patients at risk of cardiovascular events.
Location
United Kingdom
Biotest’s immunoglobulin approved in US
Thursday 27 December 2012
Biotest AG of Germany has received approval from the US Food and Drug Administration to market its immunoglobulin product, Bivigam, in the US. The approval had been held up pending the completion of additional tests.
Location
Germany
Accelerated approval for new leukaemia drug
Saturday 15 December 2012
The US Food and Drug Administration has approved a new drug to treat adults with chronic myeloid leukaemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukaemia (ALL) – three months ahead of schedule.
Location
United States
FDA approves anthrax drug from GSK
Saturday 15 December 2012
The US Food and Drug Administration has approved a new monoclonal antibody to treat inhaled anthrax, considered a potential biological terrorism threat because the spores of the bacterium are resistant to destruction and can be spread in the air.
Location
United States
Regulatory nod to Lundbeck’s drug for alcohol dependence
Saturday 15 December 2012
The European Medicines Agency’s main scientific committee has recommended that a new treatment for alcohol dependence, Selincro (nalmefene), be licensed in Europe. The H. Lundbeck A/S drug is for adults with high rates of alcohol consumption.
Location
United Kingdom
CHMP turns down antisense compound citing safety issues
Friday 14 December 2012
The Committee for Medicinal Products for Human Use has turned down an application from Genzyme (Sanofi) to market an antisense compound for familial hypercholesterolaemia citing safety concerns. Genzyme said it will appeal against the opinion.
Location
United Kingdom
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Recent Appointments
Pascale Witz to head strategic development at Sanofi
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Monday May 6 2013
Vicente Anido nominated to Nicox board
Monday May 6 2013
Jeremy Farrar named director of the Wellcome Trust
Monday May 6 2013
Harry Kirsch becomes CFO at Novartis
Monday May 6 2013