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.

The recombinant protein-based, non mRNA vaccine has been granted full marketing approval to prevent COVID-19 in adults aged 65 years and older and patients aged 12–64 years who are at risk of severe infection due to underlying conditions.

The oral combination therapy has been shown to provide a significant overall response rate in LGSOC patients with disease progression despite prior systemic treatment.

The European regulatory body’s safety committee has started its review of the vaccine after receiving reports of serious adverse events in elderly patients.

After a successful AI-assisted scientific pilot review, the agency has decided to implement the use of AI across all centers in an accelerated timescale.

The bispecific monoclonal antibody has demonstrated robust and durable responses in patients with relapse/refractory multiple myeloma.

Supported by clinical trial data, this new indication for upadacitinib provides GCA sufferers with an alternative treatment option that can achieve sustained remission.