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 ...

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

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.

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, ...

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

Eli Lilly and Co., the maker of Zepbound and Mounjaro, announced a successful Phase 3 trial for a once-daily GLP-1 pill for ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and adolescents over 12 years of age in over a decade. The FDA has approved Regeneron’s ...

Orphan drug designation does not convey any advantage in or shorten the duration of the regulatory review and approval process. If a product that has orphan drug designation subsequently receives ...