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FDA OKs new indication for Jardiance

Jardiance is now FDA approved to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure with reduced ejection fraction.
Jazz Pharmaceuticals receives FDA clearance for Xywav

Xywav is the first and only FDA-approved treatment for idiopathic hypersomnia, the company said.
Genzyme receives FDA nod for Nexviazyme

The FDA's approval of Nexviazyme gives patients with Pompe disease another enzyme replacement therapy option for this rare disease.
AstraZeneca gets FDA nod for Saphnelo

Saphnelo is a monoclonal antibody administered by intravenous infusion to treat lupus.
Merck obtains FDA OK for new indication of Keytruda

Keytruda is now approved for 30 indications.
CDC guidance: Insurers must cover HIV prevention treatment costs

Insurers, which were required to stop charging out-of-pocket fees for PrEP as of Jan. 1, have 60 days to comply with the latest rules.
Bayer gets FDA OK for Kerendia

Bayer’s Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist approved for adults with chronic kidney disease associated with Type 2 diabetes.
Fresenius Kabi debuts smaller-dose fentanyl citrate injection

Fresenius Kabi’s fentanyl citrate injection, 50 mcg per ml, is the only 1-ml presentation available of the drug.

FDA gives green light for Keytruda plus Lenvima combination