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.
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 →
Frequently asked
Is Cresthaven Analytics good for clinical-stage biotech and small biotech funds?
Yes — designed for biotech fund analysts, regulatory affairs heads, GCs at clinical-stage biotech, hospital compliance teams, and medical-device operators. Covers 11 healthcare agencies: FDA CDER, FDA CBER, FDA CDRH, CMS, EMA, MHRA, EU SANTE, ECDC, TGA, PMDA, HSA. Material approvals, advisory committee actions, safety signals, and guidance updates arrive as structured briefs within minutes. Professional at $399/month covers 6 agencies including FDA CDER + CBER + CDRH + EMA + MHRA + CMS.
What FDA centers and EU regulators does Cresthaven Analytics cover for biotech?
FDA CDER (drugs), FDA CBER (biologics including gene therapy), FDA CDRH (medical devices), CMS (Medicare/Medicaid coverage decisions), and the EU equivalents: EMA, MHRA, EU SANTE, EU HTA Coordination Group, ECDC. APAC: PMDA (Japan), TGA (Australia), HSA (Singapore). Each agency feeds structured briefs covering approvals, CRLs, advisory committee actions, safety alerts, and guidance documents.
What's the cheapest Cresthaven tier for biotech regulatory monitoring?
Basic at $149/month covers 3 agencies. A typical biotech setup is FDA CDER + FDA CBER + EMA for cross-jurisdictional pharma. Add CDRH ($29/month) for medical-device coverage, MHRA for UK exposure, or CMS for reimbursement intelligence. For a biotech fund covering both pharma and medical devices, Professional at $399/month covers 6 agencies with daily digests and cross-agency synthesis.
How does Cresthaven Analytics compare to Clarivate Cortellis or Pink Sheet for biotech regulatory intelligence?
Clarivate Cortellis and Citeline Pink Sheet are deep-database products: structured regulatory records, trial intelligence, decades-long historical archives, often priced $15,000 to $40,000 per year for small-team licenses. Cresthaven Analytics is a focused brief-delivery service: structured executive briefs delivered by email and portal, source-linked, at $149 to $999 per month. Cresthaven covers what changed and what it means; Cortellis and Pink Sheet are the right choice if you need a deep searchable database of historical regulatory records.
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