Vyjuvek Label Update: FDA Removes Lower Age Limit

Vyjuvek (beremagene geperpavec-svdt) is the first topical gene therapy approved to heal wounds in adults and children with dystrophic epidermolysis bullosa (DEB). DEB is a rare genetic skin condition in which a faulty COL7A1 gene… Read more

Opzelura: FDA Expands Use of Steroid-Free Skin Cream for Young Children With Eczema

Opzelura (ruxolitinib) is a prescription cream that helps reduce skin inflammation. It works by blocking certain proteins in the body called Janus kinases (JAKs) that help regulate the immune system and can cause skin inflammation… Read more

FDA Approves At-Home Once-Weekly Leqembi Injection as Maintenance Therapy for Early Alzheimer’s Disease

Leqembi (lecanemab-irmb) is a prescription medicine approved to treat early stages of Alzheimer’s disease, such as mild cognitive impairment or mild dementia. The recent FDA approval of Leqembi IQLIK (pronounced “I Click”) introduces a once-weekly,… Read more

FDA Expands Repatha Approval

Repatha (evolocumab) is an injectable medicine that helps lower levels of low-density lipoprotein cholesterol (LDL), often called “bad” cholesterol. Approved in 2015, Repatha can now be used in adults with poorly controlled LDL who haven’t been… Read more

Wayrilz: A New Twice-Daily Pill for Persistent and Chronic Immune Thrombocytopenia

Wayrilz (rilzabrutinib) is a new oral medicine for adults with persistent (lasting 3-12 months) or chronic (lasting more than 12 months) immune thrombocytopenia (ITP) who haven’t had success with a prior treatment. ITP is a… Read more

FDA Approves Ziftomenib: First Once-Daily Oral Therapy for Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia

Ziftomenib, sold under the brand name Komzifti, is a new oral medicine approved to treat adults with a type of blood cancer called acute myeloid leukemia (AML). It’s meant for people whose AML has come… Read more

Tezspire: FDA Approves New Option for Chronic Sinus Inflammation With Nasal Polyps

Tezspire (tezepelumab-ekko) is a prescription medicine used to treat inflammatory conditions of the airways, such as severe asthma. The FDA has now approved it as an add-on treatment for adults and children aged 12 and… Read more

FDA Approves Wegovy as First Once-Weekly Injection for Obesity-Linked Liver Disease

Wegovy (semaglutide) is a once-weekly injection that was first approved in 2017 to help with weight loss and lower the risk of heart problems. Now, the FDA has approved it to treat a liver condition… Read more

Dawnzera: First RNA-Targeted Therapy to Prevent Hereditary Angioedema Attacks

Dawnzera (donidalorsen) is a new medicine approved to help prevent attacks of a rare genetic swelling disorder known as hereditary angioedema (HAE) in people aged 12 or older. Affecting about 7,000 people in the U.S.,… Read more

Papzimeos: First Approved Immunotherapy for Recurrent Respiratory Papillomatosis in Adults

Papzimeos (zopapogene imadenovec-drba) is a new type of immunotherapy approved to treat adults with recurrent respiratory papillomatosis (RRP). RRP is a rare condition caused by certain types of human papillomavirus (HPV), which leads to non-cancerous… Read more