FDA approval for Unloxcyt was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee from Study CK ...

In its second attempt, Takeda has secured FDA approval for Eohilia, which becomes the first and only oral therapy in the US for eosinophilic oesophagitis (EoE). The US regulator has cleared ...

FDA approved Unloxcyt (cosibelimab-ipdl) for advanced or metastatic cSCC ahead of its PDUFA date of Dec. 28. Unloxcyt is the first PD-L1 blocking antibody approved for cSCC, with a recommended ...

Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea. Research shows that it considerably improves the level of AHI in patients with ...

This marks the first mesenchymal stromal cell therapy approved by the FDA for children with acute graft versus host disease. The Food and Drug Administration (FDA) approved Ryoncil (remestemcel-L-rknd ...

Hikma said on Monday it was “pleased to have FDA approval to launch this important medicine and to provide broader access and greater affordability for the patients who rely on it”.

Nemluvio is intended for individuals aged 12 years and above with moderate-to-severe atopic dermatitis. Credit: Kmpzzz/Shutterstock. The US Food and Drug Administration (FDA) has approved Galderma‘s ...

Tryngolza is once-monthly, subcutaneous RNA-targeted therapy and is expected to be available by the end of the year with a price of $595,000. The FDA has approved Tryngolza (olezarsen) to reduce ...

The FDA has granted ensartinib approval for adult patients with ALK-positive non–small cell lung cancer. Ensartinib has received FDA approval for the first-line treatment of anaplastic lymphoma kinase ...

(NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved BRAFTOVI ® (encorafenib) in combination with cetuximab (marketed as ERBITUX ®) and mFOLFOX6 ...

Accelerated approval was based on promising results from the ongoing Phase III BREAKWATER trial. The FDA has granted accelerated approval to Pfizer’s Braftovi (encorafenib) in combination with ...

Dec. 23, 2024 -- The FDA has approved the first prescription drug, Zepbound, for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Studies have shown that when ...