Ascendis Pharma (ASND) announced that the FDA has accepted for review its supplemental biologics license application, or sBLA, in adult growth hormone deficiency, or GHD, for TransCon hGH. The FDA set ...

A living evidence approach treats evidence as shared infrastructure rather than as a series of isolated projects.

The U.S. antitrust watchdog believes that its current process of reviewing large pharma mergers just doesn’t work. As experts propose heightened scrutiny, at least one analyst is projecting a ...

Discover top-rated stocks from highly ranked analysts with Analyst Top Stocks! Easily identify outperforming stocks and invest smarter with Top Smart Score Stocks An update from Ascendis Pharma ( ...

Rhythm Pharmaceuticals (NASDAQ:RYTM) announced that U.S. and EU regulators have accepted for review a potential label expansion for its obesity therapy setmelanotide, marketed as Imcivree. The U.S.

The FDA has extended the target action date by three months to August 14, 2024, from May 14 to provide time for a full submission review. The treatment has already been approved in Europe and Britain ...

Even in the era of the FDA's Commissioner's National Priority Voucher (CNPV) program, Jazz Pharmaceuticals is showing that traditional priority review vouchers (PRVs) can catch a pretty penny. In fact ...

Aurinia Pharmaceuticals Inc. stock price dropped 25% after underwhelming Q4 and full-year 2023 results. Sales of Lupkynis, indicated for lupus nephritis and the company's only commercial product, have ...

A medical representative does more than push pills; doing justice to the role requires them to master the science behind the medicines down to the very molecules. Often, they act as a liaison between ...