An effective medtech market access strategy must begin at the concept stage by simultaneously addressing patient needs, clinical workflows, regulatory requirements, and payer expectations rather than defaulting to FDA clearance as the sole priority. Startups that ignore this broader view risk bui...

FDA Approval Hemophilia Treatment expands meaningful choices for people with hemophilia A and hemophilia B whose needs have long exceeded available therapies. Pfizer’s HYMPAVZI (marstacimab-hncq) now offers a once-weekly subcutaneous non-factor option to adults and adolescents 12 years and older ...

HIV Weekly Treatment Options took a major step forward as Gilead and Merck reported that their investigational once-weekly combination of islatravir and lenacapavir successfully met the primary endpoint in two Phase 3 trials. The oral regimen maintained viral suppression in adults already control...

The Tovorafenib clinical assessment conducted under the EU Joint Clinical Assessment process has exposed critical shortcomings in the evidence base for treating BRAF-altered pediatric low-grade glioma. Despite the therapy’s potential, reviewers concluded that robust comparative data is absent for...

MDD treatment modeling demonstrates that sequenced interventions for major depressive disorder consistently deliver superior quality-adjusted life years and net monetary benefits compared with no active treatment. All examined pathways outperformed inaction, with an SSRI-first sequence followed b...

Levacetylleucine A-T treatment has delivered compelling Phase III results, producing statistically significant and clinically meaningful improvements in ataxia severity and daily function for both pediatric and adult patients with ataxia-telangiectasia (A-T). The