FDA Updates

Breyanzi becomes the first FDA-approved CAR-T therapy for relapsed marginal zone lymphoma, offering hope with impressive response rates and durable outcomes.

The FDA approves a new dose of Omlyclo, the first interchangeable biosimilar to Xolair, enhancing treatment options for allergic and inflammatory conditions.

Pirtobrutinib’s indication was expanded for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma, allowing for treatment in earlier lines of therapy.

The supplemental new drug application (sNDA) was assigned a PDUFA target action date of July 26, 2026.

The blood test helps patients avoid unnecessary and invasive biopsies.

The FDA approves Amneal's albuterol sulfate inhalation aerosol, enhancing access to vital asthma and COPD treatments for millions of Americans.

Long-term follow-up data showed that about 50% of patients achieved the trial's primary end point.

Sibeprenlimab offers a groundbreaking treatment for immunoglobulin A nephropathy, targeting APRIL to reduce kidney damage and improve patient outcomes.

The FDA approved durvalumab with FLOT chemotherapy, revolutionizing treatment for early gastric and gastroesophageal junction cancers, enhancing survival rates.

With this approval, Itvisma has become the first and only gene replacement therapy available for children 2 years and older, teenagers, and adults with SMA.

The combination has the potential to redefine the standard of care for a population that previously had limited therapeutic avenues.

FDA approves an 8-mg aflibercept injection for macular edema following retinal vein occlusion (RVO), offering flexible dosing options for improved patient care.

The biosimilars can be used to treat osteoporosis and cancer-related bone loss in certain populations.

The approval is based on results from the phase 3 DeLLphi-304 clinical trial.

The FDA accelerates approval of sevabertinib for advanced non–small cell lung cancer, showcasing promising efficacy and manageable safety in clinical trials.

Selumetinib gains FDA approval for adults with neurofibromatosis type 1, offering hope for those with inoperable plexiform neurofibromas.

With this action, Thrombate III has become the first and only antithrombin concentrate approved for adult and pediatric patients with hereditary antithrombin deficiency (hATd).

Plozasiran gains FDA approval to significantly lower triglycerides in adults with familial chylomicronemia syndrome, enhancing heart health management.

Epcoritamab-bysp demonstrated impressive response rates and improved progression-free survival.

Ziftomenib gains FDA approval as a targeted treatment for relapsed acute myeloid leukemia with NPM1 mutations, offering new hope for patients.

The FDA lifts the black box warning on hormone replacement therapy, empowering women with new options for managing menopause symptoms.

The FDA approves daratumumab and hyaluronidase for high-risk smoldering multiple myeloma, significantly improving patient outcomes and progression-free survival.

Leukogene's M2T-CD33 gains FDA orphan drug status, promising a novel immunotherapy approach for acute myeloid leukemia treatment.

As an adjunct to depression treatment, lumateperone reduced depressive symptoms and improved quality of life.

Linaclotide has been approved to treat patients 7 years and older with irritable bowel syndrome with constipation, becoming the first treatment for this indication in this age group.

The FDA has approved doxecitine-doxribtimine powder for the treatment of patients with thymidine kinase 2 deficiency developing symptoms at or before the age of 12.

Teva Pharmaceuticals recalls over 580,000 bottles of prazosin due to contamination concerns, urging patients to consult healthcare providers.

The FDA designates Stoboclo and Osenvelt as interchangeable biosimilars for denosumab, enhancing treatment options for osteoporosis and cancer-related conditions.