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 ...

Novo Nordisk, maker of Ozempic, applied for FDA approval for a weight loss pill, less than a week after rival Eli Lilly's clinical trial success.

Nearly two years after reporting successful results from a phase 3 trial of its oral version of injected obesity treatment ...

A spokesperson confirmed the Danish drugmaker has asked U.S. regulators to clear an oral version of its weight loss drug ...

From Crohn disease to uncomplicated urinary tract infections and beyond, the FDA issued several high-impact drug approvals last month.

Medtronic recently announced the FDA approval for its Simplera Sync sensor, enhancing the MiniMed 780G system with significant technological advancements. Over the past week, Medtronic's share ...

On March 28, the FDA approved Imfinzi for use in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent Imfinzi as adjuvant treatment after radical cystectomy, ...

This approval is Biocon's seventh U.S. biosimilar, enhancing their oncology portfolio and commitment to affordable biologics. The FDA has approved Jobevne, a biosimilar to Avastin, for IV use in a ...

Novo Nordisk submitted an oral version of the weight-loss formulation of semaglutide (Wegovy) for FDA approval, according to ...

Vitrakvi received full FDA approval for treating NTRK gene fusion-positive solid tumors in adults and children, following its initial accelerated approval in 2018. The drug functions as a tyrosine ...

Bayer BAYRY announced that the FDA has granted full approval to oncology drug, Vitrakvi (larotrectinib), a first-in-class TRK inhibitor. The drug is now fully approved in the United States for ...