“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) granted more than 99% of requests for patients to access unapproved drugs and biologics in fiscal year 2016, according to data released last week. Through FDA ...
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 ...
The US Food and Drug Administration (FDA) has updated its guidance for industry on expanded access to investigational drugs under an investigational new drug (IND) application. The guidance now ...
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 ...
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 ...
Navigate Global Regulatory, Operational & Supply Complexities to Accelerate Patient Access, Harness Ethical Real-World Data, & Deliver Scalable Expanded Access Programs EAPs are evolving rapidly, ...
Emalex Biosciences today announced that the first patient was dosed in its Expanded Access Program for ecopipam, an investigational first-in-class D1 receptor antagonist in development for the ...
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 ...
Emalex Biosciences today announced that the first patient was dosed in its Expanded Access Program for ecopipam, an investigational first-in-class D1 receptor antagonist in development for the ...
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