A primary benefit of the FDA Fast Track designation is how it accelerates the drug approval process. Early and continuous communication helps organizations identify and proactively address any ...

“Heading into 1Q25, we also believe BPMC could be seen as an attractive target for strategic partnerships, which could boost shares,” JP Morgan writes. With Ayvakit’s launch being a major focus for ...

AUCATZYL was approved by the FDA based on results from the FELIX clinical trial of obe-cel in adult patients with r/r B-ALL. AUCATZYL will be manufactured at Autolus' dedicated commercial ...

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia ...

At its second attempt, Astellas has won FDA approval for its first-in-class cancer therapy, Vyloy, which got the green light for certain gastric cancers. The US regulator approved Vyloy ...

The rivalry between Pfizer and MSD in pneumococcal vaccines has dialled up a notch with the FDA approval of MSD’s new shot Capvaxive, the first to be aimed specifically at adults. The 21-valent ...

A European regulatory committee now recommends approval of the Alzheimer’s treatment lecanemab a few months after rejecting the drug.

In June, GSK released results from an interim analysis of the DREAMM-8 phase 3 head-to-head trial of Blenrep in combination with pomalidomide plus dexamethasone (PomDex), versus a standard of care, ...

The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, raising questions about its future in the market. US FDA declines full ...

WASHINGTON, Nov. 14, 2024 (GLOBE NEWSWIRE) -- 60 Degrees Pharmaceuticals, Inc. (NASDAQ: SXTP; SXTPW) (the “Company”), a pharmaceutical company focused on developing new medicines for infectious ...

The Russian Government Commission on Legislative Activities advanced a bill on November 11 to tax cryptocurrency operations through corporate profit tax and personal income tax systems, Russian ...

LOOK: Vice President Sara Duterte attends the Senate's plenary deliberations on the budget of her office. To recall, the Senate finance committee has adopted the House's decision to allocate P733M for ...