FDA approves new heart failure combination therapy The US Food and Drug Administration has approved a new drug for heart failure that has “overwhelming benefit” for patients, according to the researchers who trialled the medicine.…
Cystic fibrosis therapy approved by US Food and Drug Administration A combination therapy of two drugs that target the most common genetic mutation responsible for cystic fibrosis has been given a licence in the United States.…
Nivolumab granted positive scientific opinion under UK early access scheme Nivolumab, a new lung cancer drug, has been granted a positive scientific opinion by the UK medicines safety regulator under the Early Access to Medicines Scheme (EAMS).…
Panobinostat set for approval in Europe as multiple myeloma treatment The multiple myeloma drug panobinostat has received a positive opinion from the European Medicines Agency for the treatment of relapsed or refractory disease.…
Cangrelor approved for use in the United StatesCangrelor has been approved for use in adult patients undergoing percutaneous coronary intervention in the United States, following a decision by the US Food and Drug Administration.…
‘Female Viagra’ wins approval from FDA expert panel A drug developed to increase female libido is a step closer to being approved in the United States. …
Pfizer apologises for Lyrica but presses ahead with patent protection strategy Pfizer has apologised to pharmacists and GPs over any extra work or confusion caused by its attempts to protect the second medical use patent of its product Lyrica.…
FDA approves two new drugs for irritable bowel syndrome The US Food and Drug Administration has approved two new treatments for patients with irritable bowel syndrome with diarrhoea.…
PCSK9 inhibitor evolocumab gets green light for European approval The first monoclonal antibody for treating high cholesterol and the first PCSK9 inhibitor is set to launch following a positive opinion from the European Medicines Agency.…
European Medicines Agency tightens conflict of interest rules for its expert advisersEurope’s medicines safety regulator has tightened up its conflict of interest rules for scientific committee members and expert advisers in updated policy guidance.…
