FDA Approves First Oral Treatment for Rare Swelling Disorder

July 8, 2025 – The FDA has approved the first-ever pill to stop attacks of a rare genetic swelling disorder while they’re happening.The drug, known as sebetralstat but sold as Ekterly, is for adults and… Read more

Epkinly: FDA Approves New Bispecific Antibody Option for Relapsed or Refractory Follicular Lymphoma

Epkinly (epcoritamab-bysp) is a type of cancer treatment called a bispecific antibody that helps your immune system find and destroy certain cancer cells by connecting immune cells (T cells) to cancer cells (B cells).Epkinly is… Read more

Zycubo: FDA Approves First Under-the-Skin Shot for Treating Menkes Disease in Children

Zycubo (copper histidinate) is a new under-the-skin injection that the FDA has approved for treating children with a rare genetic condition that affects copper metabolism, known as Menkes disease.Menkes disease is caused by mutations in… Read more

Accrufer: FDA Expands Use of Oral Iron Treatment for Kids Ages 10 and Older

Accrufer (ferric maltol) is an oral capsule approved by the FDA to treat iron deficiency in kids ages 10 years and older.It helps your body absorb iron through your digestive system, which is important for… Read more

Lunsumio Velo: FDA Approves a Convenient Under-the-Skin Shot for Relapsed or Refractory Follicular Lymphoma

Lunsumio Velo  (mosunetuzumab-axgb) is a new under-the-skin (subcutaneous) injection version of the anticancer medicine Lunsumio intravenous infusion.The FDA has granted accelerated approval to Lunsumio Velo for treating adults with follicular lymphoma that has come back (relapsed) or… Read more

FDA Approves Once-Daily Wegovy Pill as the First Oral GLP-1 Medicine for Weight Loss in Adults With Obesity or Overweight

Wegovy (semaglutide) is a prescription medicine that helps with weight loss and lowers the risk of heart problems and liver disease.The FDA has approved its oral pill form to be used alongside a low-calorie diet… Read more

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