The answer is that Pharming was granted the PRV by the FDA after it claimed approval for Joenja (leniolisib), a therapy for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare and ...

The US Food and Drug Administration announced Thursday that it will be phasing out a requirement that monoclonal antibodies ...

The FDA on Thursday gave the green light to Uplizna in IgG4-related disease, making it the first and only approved treatment ...

Fitusiran is a small interference RNA therapeutic designed to prevent bleeds in patients with hemophilia A or B by lowering antithrombin.

FDA Approves Losartan Oral Suspension Arbli Furoscix (furosemid injection) Loop diuretic Treatment of edema in patients with chronic kidney disease, including nephrotic syndrome. Wearable ...

In November, Mr. Biden set out to change that with a new rule that would drastically expand access to this type of medication ...

Four years after getting the first drug approved by the FDA to treat rare disease hereditary ATTR amyloidosis, Alnylam has got the go-ahead for a second – Amvuttra – which has a simpler ...

The use of drugs like Ozempic, Wegovy and Zepbound in people with type 1 diabetes has risen sharply over the past decade, a ...

After a legal decision delayed its entry last fall, Sun Pharma has received the all-clear to tap into the U.S. | After Sun ...

President Donald Trump's approval ratings dipped to a new second-term low following a week of sweeping decisions impacting global trade, the U.S. stock market, libraries and health research ...

Soleno Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the ...

Outlook Therapeutics (OTLK) announced that the U.S. Food and Drug Administration, FDA, has acknowledged receipt of the resubmission of the ...