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

Hyrnuo: New Oral Treatment for Advanced HER2-Mutant Lung Cancer

Hyrnuo (sevabertinib) is a new oral medicine for adults with advanced nonsquamous non-small-cell lung cancer (NSCLC) carrying a specific genetic change known as HER2 (ERBB2) TKD activating mutations and whose cancer has either advanced locally… Read more

Keytruda and Padcev: FDA Approves New Combination Therapy for Aggressive Bladder Cancer

The FDA has approved a new combination therapy that uses two different types of anticancer medicines for treating adults with muscle-invasive bladder cancer (MIBC) who can’t receive cisplatin, a common chemotherapy drug. The approved combination… Read more

Imdelltra Receives Full FDA Approval as First-In-Class Immunotherapy for Advanced Small-Cell Lung Cancer

Imdelltra (tarlatamab-dlle) is a first-of-its kind targeted cancer medicine called a bispecific T-cell engager approved for treating adults with extensive-stage small-cell lung cancer (ES-SCLC) that has gotten worse on or after chemotherapy with platinum-based cancer… 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

Fasenra: FDA Approves Under-the-Skin Shot to Help Reduce Flares in Hypereosinophilic Syndrome

Fasenra (benralizumab), a targeted medicine called a monoclonal antibody, binds to and reduces levels of eosinophils, a type of immune cell that can cause inflammation. This can ease symptoms in people with eosinophil-driven conditions. First… Read more

Trimbow: A Triple-Combination Inhaler for Asthma Maintenance in Adults

Trimbow (beclomethasone dipropionate/formoterol fumarate/glycopyrrolate), a single inhaler that contains three medicines, is now FDA-approved for maintaining asthma control in adults. About 27 million Americans have asthma, of which 30% to 50% have frequent symptoms that… Read more

Datroway: FDA Approves Antibody-Drug Conjugate Injection for Advanced Triple-Negative Breast Cancer

Datroway (datopotamab deruxtecan-dlnk) is a prescription intravenous targeted cancer medicine called an antibody-drug conjugate (ADC). The FDA has approved it for adults with triple-negative breast cancer (TNBC) when the tumor cannot be removed with surgery… Read more

FDA Clears Once-Daily Linzess Capsule for Functional Constipation in Children Ages 2 Years and Older

Linzess (linaclotide) is a prescription once-daily oral medicine used to treat certain types of constipation, including those with no known cause and those related to irritable bowel syndrome (IBS-C). In the current approval, the FDA… Read more

Imfinzi: FDA Approves Immunotherapy Plus BCG Combination for High-Risk Early Non-Muscle-Invasive Bladder Cancer

Imfinzi (durvalumab) is a prescription immunotherapy medicine used to treat different types of cancer. The FDA has approved the combination of Imfinzi and Bacillus Calmette-GuĂ©rin (BCG) therapy to treat a high-risk, early form of bladder… Read more