If the application is successful, the therapy will become the first-line treatment for patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy.

The company is advancing its lead KV7 potassium channel modulator azetukalner through multiple Phase III trials in epilepsy and mood disorders, and planning its transition to commercial-stage growth.

The CDMO’s North Carolina facility has successfully completed an FDA inspection thereby validating its quality systems and commercial readiness to reinforce its position as a leader in complex topical and transdermal drug manufacturing.

The regulator’s decision will provide a new clinical option for patients with early gastric and gastroesophageal cancers that can deliver a significant survival benefit versus chemotherapy alone.

The company’s circVec 4.0 demonstrates unprecedented gene expression levels in heart and brain tissues to open new therapeutic opportunities across multiple organs.

Having secured a European Commercial CGMP Manufacturing License from FIMEA, Nanoform is now able to produce and control the quality of nanoformed APIs for Europe and other key markets.

In light of the evolving therapeutic landscape, increasing use of advanced technologies, and political shifts, regulatory updates are inevitable, meaning that bio/pharma companies will need to adjust quickly to new requirements.

The company has decided to voluntarily withdraw obeticholic acid from the U.S. market after the FDA issued a request for the withdrawal and put a clinical hold on trials involving the drug.  

FDA has granted approval to Viatris for its generic intravenous iron replacement product as a treatment of iron deficiency anemia in adult and pediatric patients with chronic kidney disease.

If the oral antibiotic gains regulatory approval, patients who are 12 years of age and older in the U.S. suffering from urogenital gonorrhea will have an alternative, non-invasive treatment option.

This latest FDA leadership appointment comes as the agency focuses on balancing regulatory challenges with opportunities for accelerated patient access.

Pegcetacoplan (EMPAVELI), which was shown to be safe and effective in a Phase III clinical trial, is now approved for the treatment of U.S. patients 12 years and older with C3G and primary IC-MPGN.

Contrasting outcomes for Roche’s investigational anti-ST2 monoclonal antibody treatment for COPD, mean the company needs to discuss the outcomes with regulatory authorities and evaluate next steps.

While the final regulatory decision is expected in the first half of 2026, the expanded use of Arexvy, to include younger at-risk adults, could help protect more than 21 million Americans vulnerable to RSV.

Oral solid dosage formulation strategies are being reshaped to align with the evolving regulatory landscape and to enhance patient safety by mitigating potential contamination risks.

With the durvalumab-based perioperative regimen, MIBC patients have a new treatment option that has been proven to provide statistically significant and clinically meaningful improvement in survival rates.

This regulatory decision, which has been accepted under an accelerated basis, makes sunvozertinib the only approved targeted oral treatment for NSCLC with EGFR exon20ins.

The once-monthly injection, which is the first FDA-approved HAE treatment, was proven to significantly reduce HAE attacks in a Phase III trial and strengthens CSL’s presence in the competitive rare disease market.

As a result of the capability to be used across multiple therapeutic programs, the U.S. regulatory body has granted Sarepta’s AAVrh74 platform with platform technology designation.

This approval, which was based on the results of a Phase III trial demonstrating a higher relative efficiency of the new vaccine compared with the old version, marks the third for the company from the FDA.