FDA Expands Jascayd Approval to Adults With Progressive Pulmonary Fibrosis

Jascayd (nerandomilast) is now approved for treating adults with progressive pulmonary fibrosis (PPF) that causes gradual and permanent scarring in the lungs, making it harder to breathe over time.Jascayd was previously approved to treat idiopathic… Read more

Fesilty: FDA Approves New Treatment Option for Rare Bleeding Disorder

Fesilty (fibrinogen, human-chmt) is a newly approved treatment for sudden bleeding episodes in both children and adults with a rare condition called congenital fibrinogen deficiency (CFD).CFD is a condition where the body makes too little… Read more

FDA Approves Rybrevant Faspro: An Under-the-Skin Injection for Use in Combination With Lazcluze for EGFR-Mutated Lung Cancer

Rybrevant Faspro is a new under-the-skin (subcutaneous) injection form of the cancer medicine Rybrevant (amivantamab).The FDA has now approved it in combination with another medicine called lazertinib (Lazcluze) as a first-line treatment for a type of… Read more

FDA Approves Myqorzo, a New Oral Therapy for Obstructive Hypertrophic Cardiomyopathy

Myqorzo (aficamten) is a new oral medicine approved by the FDA for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). It relieves symptoms, improves heart function, and provides better stamina for daily activities. Hypertrophic cardiomyopathy (HCM)… Read more

Exdensur: FDA Approves New Twice-Yearly Medicine for Severe Asthma

Exdensur (depemokimab) is a new type of ultra long-acting biologic medicine approved by the FDA as an add-on maintenance treatment for severe eosinophilic asthma — a type of asthma linked to high levels of eosinophils… Read more

Cardamyst: FDA Approves Nasal Spray for Sudden Fast Heartbeats

Cardamyst (etripamil) is a new nasal spray for treating sudden episodes of fast heartbeats, known as paroxysmal supraventricular tachycardia (PSVT), and restoring a normal heart rhythm in adults.It is the first self-administered medicine approved by… Read more

Inlexzo: A New Bladder Cancer Treatment

Inlexzo is a new treatment for a type of bladder cancer in adults that hasn’t spread to the muscles and doesn’t respond to Bacillus Calmette-Guérin (BCG) therapy. It’s approved for treating non-muscle invasive bladder cancer… Read more

FDA Expands Approved Use of Vonvendi

Vonvendi is a lab-made version of von Willebrand factor (VWF), a protein your body needs for blood to clot.Affecting more than 3 million people in the U.S, von Willebrand disease (VWD) is a common inherited… Read more

FDA Approves Zanvastro for Rare Brain Disorder Alexander Disease

What Is Zanvastro and How Does It Work? The FDA has approved Zanvastro (zilganersen) to treat adults and children with Alexander disease. Alexander disease is a very rare and severe brain disorder that gets worse… Read more

FDA Approves Fayuvi, First Gene Therapy for Children With Sanfilippo Syndrome Type A

What Is Fayuvi and How Does It Work? The FDA has approved Fayuvi (rebisufligene etisparvovec) to treat brain-related symptoms in children with a rare genetic disease called Sanfilippo syndrome type A, also known as mucopolysaccharidosis… Read more