The FDA has issued a complete response letter (CRL) to Merck & Co's gefapixant candidate for refractory chronic cough, delaying the programme and giving Bayer an opportunity to close th
After regulatory hold-ups in the US and Europe, Ipsen has claimed a confidence-boosting approval in Canada for palovarotene, a rare disease therapy acquired via its $1.3 billion takeover of
The man who sent the price of lifesaving drug Daraprim (pyrimethamine) rocketing from $13.50 a tablet to $750 overnight has been ordered to repay $64.6m (£47m).
Robert Califf has cleared another stage on his return journey to the top job at the FDA, after the influential Senate committee on Health, Education, Labour and Pensions (HELP) voted by 13
Preliminary data from an ongoing trial of AstraZeneca's COVID-19 vaccine Vaxzevria has shown that a booster dose stimulates an increase in antibodies against Omicron, as well as other varia
Swiss biotech Idorsia has claimed FDA approval for its first product – insomnia treatment Quviviq – setting up a market challenge to class rivals from Merck & Co and Eisai.
A pharma company’s core mission is to improve patient outcomes. This hinges on effectively influencing HCP clinical behaviour and driving disease education.