Healthcare & Life Sciences
FDA CBER, FDA CDRH, CMS, EMA, ECDC, MHRA, EU HTA, PMDA, HSA, TGA — biologics, medical-device, and reimbursement intelligence for pharma, biotech, and digital health.
11 Agencies covered
11 Sample briefs available
US
- FDA + DEA FDA approves orforglipron (Foundayo) as first oral small-molecule GLP-1 receptor agonist, establishing a new NDA precedent for non-peptide GLP-1 agents in type 2 diabetes and obesity Read sample brief →
- FDA CBER FDA approves Otarmeni, the first-ever gene therapy for genetic hearing loss, under the Commissioner's National Priority Voucher pilot in 61 days — tied for the fastest BLA approval in modern FDA history Read sample brief →
- FDA CDRH FDA CDRH issues final guidance establishing cybersecurity requirements for premarket submissions of connected medical devices Read sample brief →
- CMS via Federal Register API CMS finalizes Contract Year 2027 Medicare Advantage and Part D rule, advancing prescription payment plan, dual-eligible reforms, and revised Star Ratings methodology Read sample brief →
EU
- European Medicines Agency EMA CHMP recommends conditional marketing authorization for LentiGene-B, a lentiviral gene therapy for transfusion-dependent beta-thalassemia Read sample brief →
- Medicines & Healthcare products Regulatory Agency MHRA and NICE launch aligned pathway to accelerate NHS patient access to new medicines by up to six months Read sample brief →
- European Commission SANTE EU HTA Coordination Group publishes first joint clinical assessment report under Regulation 2021/2282 establishing precedent for centralized EU health technology evaluation Read sample brief →
- European Centre for Disease Prevention & Control ECDC issues Rapid Risk Assessment on sustained human-to-human transmission of avian influenza A(H5N1) clade 2.3.4.4b in two EU member states Read sample brief →
APAC
- Therapeutic Goods Administration TGA publishes final regulatory framework for software-based medical devices incorporating AI and machine learning under the Therapeutic Goods Act 1989 Read sample brief →
- Pharmaceuticals & Medical Devices Agency PMDA approves first regenerative medicine product under the expedited SAKIGAKE designation pathway for allogeneic mesenchymal stem cell therapy in acute graft-versus-host disease Read sample brief →
- Health Sciences Authority HSA implements unified product defect reporting and recall framework spanning therapeutic products and cell, tissue and gene therapy products, harmonizing Singapore's post-market surveillance architecture Read sample brief →