Understand key players in the regulatory space
Gain immediate access to 5 in-depth regulatory reports spotlighting groundbreaking therapies shaping the future of healthcare. Explore insights into their regulatory pathways, compliance strategies, and innovative approaches.
What you’ll get:
- Expert analysis on FDA approval processes and accelerated pathways.
- Key data points and trends driving regulatory decisions.
- Actionable intelligence for strategic planning.
Download all 5 reports in one click
What’s inside the reports
Zolbetuximab
Explore Zolbetuximab, a first-in-class antibody targeting CLDN18.2 for metastatic gastric cancers, under the FDA’s accelerated Real-Time Oncology Review. This report highlights the regulatory strategy, competitive landscape, and key safety and efficacy considerations.
Arexvy & Abrysvo
Arexvy™ and Abrysvo™ are the first FDA-approved RSV vaccines for high-risk populations: older adults and infants. Approved after just one RSV season, these vaccines provide urgent protection but require further studies to assess long-term effectiveness and risks.
Casgevy & Lyfgenia
Casgevy™ and Lyfgenia™ are the first FDA-approved gene therapies for sickle cell disease, approved under expedited programs. While showing impressive results, they raise unique regulatory challenges and safety concerns, requiring further studies and postmarketing surveillance.
Talvey
Talvey™ (talquetamab), a first-in-class bispecific antibody for multiple myeloma, received accelerated FDA approval in 2023 for adults with relapsed or refractory disease. It offers new hope for patients with significant unmet needs. This report covers the regulatory strategy, competitive landscape, and key safety and efficacy concerns.
Tarpeyo / Kinpeygo
Tarpeyo®/Kinpeygo® is the first FDA-approved treatment for immunoglobulin A nephropathy (IgAN), a rare kidney disease, granted accelerated approval in 2021 based on a surrogate endpoint. Initially approved with a limited indication, it was later expanded after follow-up data.
