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

Enhertu Plus Pertuzumab: New First-Line Option for Advanced HER2-Positive Metastatic Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is a type of targeted cancer treatment called an antibody-drug conjugate. The FDA has approved it in combination with another medicine, pertuzumab, as the first-line treatment for adults with HER2-positive breast cancer… Read more

Omisirge: A New Cell Therapy for Severe Aplastic Anemia and Blood Cancers

Omisirge (omidubicel-onlv) is a type of cell therapy made from umbilical cord blood. It helps your body make new blood cells after a stem cell transplant. What makes Omisirge different is that the cells are… Read more

Voyxact: FDA Grants Accelerated Approval to Once-Monthly Injection for Adults With IgA Nephropathy

Voyxact (sibeprenlimab-szsi) is a new medicine approved by the FDA to lower protein levels in urine for adults with a kidney condition called primary immunoglobulin A nephropathy (IgAN) who are at risk of their illness… 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

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