FDA Updates

The approval is significant for a condition that is estimated to affect fewer than 1 in 1 million individuals.

Ipsen discontinues tazemetostat after SYMPHONY-1 safety signals; pharmacists and FDA guide next steps for EZH2-mutant follicular lymphoma patients.

The FDA approves Bristol Myers Squibb’s deucravacitinib (Sotyktu), a first oral tyrosine kinase 2 inhibitor for active psoriatic arthritis.

FDA approval expands the use of teclistamab plus daratumumab, which significantly improved survival in the MajesTEC-3 trial.

Lomitapide demonstrated substantial LDL cholesterol reductions in a pivotal trial.

Milsaperidone is indicated for acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia in adults.

FDA priority review of rusfertide signals a new PV option, cutting phlebotomy reliance and improving hematocrit control, with pharmacists guiding injections and safety.

Somapacitan-beco becomes the first and only once-weekly growth hormone approved for children with idiopathic short stature, those born small for gestational age, and those with Noonan syndrome, offering an alternative to daily injections.

The approval is supported by findings from the phase 1 Beamion LUNG-1 clinical trial.

The approval for the oral, fixed-duration chronic lymphocytic leukemia (CLL) regimen was based on results from the phase 3 AMPLIFY trial.

FDA approves encorafenib plus cetuximab chemotherapy for BRAF V600E metastatic colorectal cancer, boosting survival and response in BREAKWATER.

FDA clears pegzilarginase-nbln enzyme therapy for ARG1-D, cutting toxic arginine and boosting mobility.

With this action, dupilumab has become the first and only FDA-approved treatment for allergic fungal rhinosinusitis.

The FDA accepts Moderna’s mRNA flu vaccine filing, targeting adults 50 years and older, with an accelerated path for older adults and a 2026 decision deadline.

FDA accepts Iberdomide new drug application for relapsed or refractory multiple myeloma; pharmacists prepare for oral anti-CD38 combos, MRD-driven care.

FDA approves difamilast (Adquey), a topical PDE4 inhibitor, expanding nonsteroidal options for mild to moderate atopic dermatitis in dermatology patients 2 years and older.

The FDA approves a once-monthly dosing schedule for amivantamab and hyaluronidase-lpuj to optimize administration and cut down infusion times.

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.

Zavabresib receives orphan drug designation for myelofibrosis, offering hope for patients unresponsive to current treatments and enhancing therapeutic options.

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