Senseonics has started first-in-human testing of Freedom, a fully transmitter-free implantable CGM that communicates directly with a smartphone — but the device is roughly twice the length of its ...

Most biotech companies spend their time creating value. Far fewer have to figure out how to rebuild it. Erik Wiklund, CEO of Norwegian biotech Circio, has done both. Most biotech companies spend their ...

After the 2000s neuroprotection failures, stroke drug development is reviving. Scp776 (IGF-1) and loberamisal show early ...

Indonesia’s Ministry of Health told the Asia-Pacific self-care congress that it is fully committed to self-care, as new rules ...

The FAST-EU pilot is accelerating the review of multinational clinical trial applications as intended, but the high ...

FDA advisory committee members and agency reviewers signaled that the "fast progressor" subgroup analysis that helped Sydnexis' SYD-101 win European approval is unlikely to persuade the FDA.

GuruNanda challenge leads to Davids Health Sciences withdrawing ad claims. Separately, NAD forwards questions to federal regulators about claims for Red Light brand hat and mask after HigherDose ...

NAD review of advertising for Carpe deodorant should resonate with other start-ups relying on subscription programs as primary sales driver as well as larger businesses, such as P&G, which challenged ...

Estée Lauder CEO Stéphane de La Faverie says the firm’s fragrance performance is ‘one, if not the best’ in the industry, with organic sales up 20% and operating income up 93% in the fiscal first ...

Inovio sets a $460,000 list price for a full course of Voceryq, its first approved DNA medicine and the second approved to treat recurrent respiratory papillomatosis.

The company declined to publicly disclose the price of the new breast cancer treatment, but the US WAC is $24,392 for a monthly supply, according to a filing with the Vermont Attorney General.

FDA’s practice of deciding forfeiture only when a later applicant seeks approval leaves first-filers guessing for years, industry reps say during an AAM conference session on potential GDUFA ...