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.

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 ...

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 ...

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.

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.

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 success of the first Phase III trial of Moderna/Merck & Co.’s intismeran autogene at ESMO has sparked questions over the place of the pioneering individualized vaccine on the melanoma treatment ...