Unipath Diagnostics will introduce its ClearPlan Easy OTC electronic fertility monitor in the first quarter of 1999 following 510(k) clearance by FDA on Oct. 30. The U.S., where about 3.5 million women become pregnant each year, will be the product's first market. Packaged with 20 disposable urine test sticks, the device will have a suggested retail price of $200. A pack of 30 additional test sticks will cost about $50.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
