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FDA approves Urovant's Gemtesa as overactive bladder treatment

Last updated: Jan. 5, 2021

Following a better-than-expected commercial liftoff for the overactive bladder medicine Gemtesa (vibegron) in its first market, Japan, the Dec. 23 FDA approval for the medicine opens a new commercial chapter for Urovant Sciences, a company that’s on its way to being a wholly owned subsidiary of Sumitomo Dainippon Pharma Co. Ltd.'s Sumitovant Biopharma Ltd.

BioWorld Asia Regulatory Genitourinary/Sexual Function FDA

Accuracy, utility of COVID-19 lateral flow tests questioned in the U.K.

BioWorld MedTech

LONDON – A huge row has broken out in the U.K. about the accuracy and utility of COVID-19 lateral flow tests (LFT) in screening asymptomatic people, as a pilot...

Total artificial heart being manufactured

Carmat's artificial heart receives CE mark

BioWorld MedTech

Carmat SA said its total artificial heart received the CE mark, and the company plans to ramp up production to enable the launch of the device in the second...

Today's news in brief

BioWorld

BioWorld briefs for Jan. 15.

Israel continues to shine as hub of med-tech innovation

BioWorld MedTech

In recent years, Israel has proven to be a hot spot for med-tech innovation. The country boasts more than 1,500 companies in the health care and life sciences...

Sarepta DMD phase II hangs in ‘balance’ as disparity in North Star leads astray

BioWorld

Sarepta Therapeutics Inc.’s miss on a key phase II ambulatory endpoint in its Duchenne muscular dystrophy (DMD) trial may have been caused by a dramatic disparity...