FDA Updates

The biosimilar is a cost-effective treatment for patients with conditions caused by cancer treatment.

The label change removes boxed warnings of cardiovascular disease, breast cancer, and probable dementia from certain hormone replacement therapy products.

Innovent’s trispecific antibody IBI3003 has received FDA fast track designation for R/R MM, supported by early clinical data showing strong efficacy and manageable safety in heavily pretreated and high-risk patients.

The FDA targets mass-marketed compounded GLP-1 drugs, warning of safety risks and deceptive ads as enforcement ramps up for weight-loss injectables.

The FDA declines to review Moderna’s mRNA flu vaccine filing over comparator choice, despite positive phase 3 results.

The updates allow for patients of reproductive age to complete pregnancy tests at home during or after treatment.

FDA approval expands pembrolizumab (Keytruda) for PD‑L1+ platinum‑resistant ovarian cancer, pairing with paclitaxel ± bevacizumab to improve survival outcomes.

Dato-DXd is a promising first-line treatment for metastatic triple-negative breast cancer, enhancing patient outcomes.

The FDA cited human factors unrelated to the drug's efficacy as the reason for rejection.

The FDA prioritizes centanafadine's review for ADHD treatment, offering a novel, once-daily oral option for diverse patient needs.

The FDA approved the first dual-agent eye drops for presbyopia, offering a groundbreaking solution for age-related near vision loss.

FDA approves a new quadruplet therapy for newly diagnosed multiple myeloma, enhancing treatment options for patients ineligible for stem cell transplant.

The FDA expands Cerezyme's approval for treating non-CNS symptoms of type 3 Gaucher disease, marking a significant advancement in patient care.

FDA's draft guidance on MRD and CR as end points accelerates multiple myeloma therapy approvals, enhancing patient access and transforming oncology practices.

FDA grants priority review for gedatolisib, a promising treatment for advanced HR+/HER2– breast cancer, showcasing significant efficacy in recent trials.

The glucagon-like peptide-1 (GLP-1) receptor agonist medications evaluated included semaglutide, tirzepatide, and liraglutide.

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.

FDA approves mosunetuzumab's subcutaneous formulation, enhancing treatment access for relapsed follicular lymphoma.

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.