FDA Updates

According to the news release, the manufacturers have 30 days to respond.

The treatment was granted a Prescription Drug User Fee Act target action date of May 10, 2026.

Subcutaneous copper histidinate injections deliver copper in a form that bypasses the genetic defect caused by Menkes disease.

The FDA approves Naox Link, a groundbreaking in-ear EEG device, transforming brain monitoring and enhancing neurologic care for patients and pharmacists.

The vouchers are intended to speed up review times for drugs that could fill key unmet needs for Americans.

The complete response letter (CRL) was issued following regulatory updates provided to Sanofi from the FDA.

FDA considers relaxing dietary supplement warning labels, raising concerns about consumer safety and informed decision-making among users.

The FDA approval of Boncresa and Oziltus, new denosumab biosimilars, enhances access to treatments for osteoporosis and cancer-related bone loss.

The FDA approved mitapivat, the first oral therapy for thalassemia due to anemia, offering hope for patients with transfusion-dependent and non–transfusion-dependent forms.

Narsoplimab gains FDA approval for treating transplant-associated thrombotic microangiopathy, showing promising survival rates in high-risk patients.

FDA approves lumateperone as a new adjunct therapy for major depressive disorder, offering hope for those with persistent symptoms despite treatment.

Nufymco, the FDA-approved ranibizumab biosimilar, enhances treatment options for retinal diseases, improving patient access and affordability.

The FDA approved the first oral GLP-1 pill for weight management, offering a convenient alternative for obesity treatment and enhancing patient access.

The FDA approves Accrufer for children 10 and older, offering a well-tolerated solution for iron deficiency, enhancing pediatric health outcomes.

The novel agent has demonstrated efficacy in symptomatic and less severe patients with obstructive hypertrophic cardiomyopathy in thorough phase 3 clinical trials.

Fam-trastuzumab deruxtecan-nxki (T-DXd) promises enhanced outcomes for HER2-positive early breast cancer patients post-neoadjuvant treatment.

The approval offers hope for improved lung function and new treatment options for patients.

The most impactful FDA approvals of 2025 feature groundbreaking treatments for mental health, STIs, diabetes, pain relief, and cardiovascular health.

FDA approves Fesilty, a new fibrinogen concentrate, offering hope for effective treatment of congenital fibrinogen deficiency and acute bleeding episodes.

FDA approves Rybrevant Faspro, a groundbreaking subcutaneous therapy for EGFR-mutated lung cancer, enhancing patient comfort and survival rates.

The approval was supported by findings from the TRITON3 trial, which enrolled certain patients with metastatic castration-resistant prostate cancer (mCRPC).

The FDA approves depemokimab-ulaa as a long-acting treatment for severe asthma, enhancing patient care with fewer injections and improved outcomes.

FDA approves zoliflodacin, a groundbreaking oral treatment for gonorrhea, offering hope against antibiotic resistance and improving patient access.

FDA grants a national priority voucher to teclistamab and daratumumab for relapsed/refractory multiple myeloma, enhancing treatment approval speed.

The approval is supported by findings from the phase 3 DESTINY-Breast09 trial.

The FDA-approved flibanserin represents the first and only once-daily oral pill for postmenopausal women with hypoactive sexual desire disorder.

Lerodalcibep, a new PCSK9 inhibitor, offers a convenient monthly injection to effectively lower LDL cholesterol in patients with hypercholesterolemia.

Pivotal FDA approvals in breast cancer treatment focused on precision medicine and innovative therapies in 2025.