“Let it grow, let it blossom,” said Eric Clapton, and so the Food and Drug Administration expects of expanded access programs with the issuance of its guidance on “Expanded Access to Investigational ...

The US Food and Drug Administration (FDA) on Monday launched a new pilot program, dubbed Project Facilitate, aimed at helping physicians complete expanded access requests for cancer patients. “The FDA ...

Regulatory Focus' ongoing series of Regulatory Explainers wants to take complicated regulatory topics and make them simple for anyone to understand. In our latest Regulatory Explainer, we break down ...

Program provides access to leronlimab for patients with limited treatment options while supporting ongoing clinical development ...

MENLO PARK, Calif.--(BUSINESS WIRE)--MedaSystems, the leading SaaS platform for Expanded Access (EA) and Investigator-Initiated Studies (IIS), today announced additional funding from existing ...

Navigate Global Regulatory, Operational & Supply Complexities to Accelerate Patient Access, Harness Ethical Real-World Data, & Deliver Scalable Expanded Access Programs EAPs are evolving rapidly, ...

BALDWIN PARK, Calif., Jan. 26, 2026 /PRNewswire/ -- StemCyte, Inc. today announced that the U.S. Food and Drug Administration (FDA) has cleared an Expanded Access (EA) program for RegeneCyte®, the ...

ImmunityBio Inc. (NASDAQ:IBRX) is one of the 13 Best Long-Term Penny Stocks to Buy According to Analysts. On June 2, ImmunityBio Inc. (NASDAQ:IBRX) announced that it attained Expanded Access ...

CULVER CITY, Calif.--(BUSINESS WIRE)-- ImmunityBio, Inc. (IBRX), a leading immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Expanded Access ...

PURCHASE, N.Y., Feb. 05, 2026 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (CGTX),, a clinical-stage company developing drugs that treat neurodegenerative disorders, has extended the duration of ...