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 ...

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 ...

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.

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 ...

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 ...

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 ...

The FDA has classified Werfen’s recall of four lots of its HemosIL AcuStar HIT diagnostic test as Class I after performance issues raised concerns about false-negative results that could delay ...

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.

LIB Therapeutics will launch its autoinjector for once-monthly Lerochol (lerodalcibep), available now in a prefilled syringe, with a $300 monthly list price – the lowest of the PCSK9 inhibitor class.

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.

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 ...