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… 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… 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… Read more

FDA Approves Uplizna: A Twice-Yearly Targeted Therapy for Adults With Generalized Myasthenia Gravis

Uplizna (inebilizumab-cdon) is a prescription medicine recently approved by the FDA to treat adults with generalized myasthenia gravis (gMG) who test positive for certain antibodies — either anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase… Read more

FDA Approves Lerochol: A Monthly Injectable Treatment to Reduce High LDL Cholesterol Levels in Adults

Lerochol (lerodalcibep-liga) is a new medicine approved by the FDA to help lower elevated levels of low-density lipoprotein cholesterol (LDL-C), often called “bad cholesterol,” in adults with hypercholesterolemia (high cholesterol levels), including those with a… Read more

Waskyra: First Gene Therapy for Wiskott-Aldrich Syndrome

  Waskyra (etuvetidigene autotemcel) is a new gene therapy approved to treat Wiskott-Aldrich syndrome (WAS), a rare inherited condition that affects the immune system and blood cells. People with WAS often have frequent infections, easy… Read more

Itvisma: FDA Approves One-Time Gene Therapy for Spinal Muscular Atrophy in Children 2 or Older, Teens, and Adults

Itvisma (onasemnogene abeparvovec-brve) is a gene therapy that the FDA has approved to treat spinal muscular atrophy (SMA) in adults, teens, and children 2 or older who have a confirmed mutation in the survival motor… Read more

FDA Approves Redemplo to Lower Triglycerides

Redemplo (plozasiran) is a type of medicine called a small interfering RNA (siRNA) therapy approved to help lower extremely high triglyceride levels in adults with familial chylomicronemia syndrome (FCS) or ongoing chylomicronemia. This medicine works… Read more

Xocova: FDA Approves First Oral Post-Exposure Prophylaxis to Help Prevent COVID-19 in Adults and Adolescents 12 and Older

Xocova (ensitrelvir) is a prescription antiviral medicine you take by mouth to lower your chance of getting COVID-19 after you have been in close contact with someone who has the virus. It is approved for… Read more