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Press Releases
CorTec’s Brain Interchange™ Accepted into FDA Total Product Life Cycle Advisory Program (TAP)
April 23, 2026
·
5 min read
Press Releases
USP Publishes Product-Specific Emerging Biologics Standards for Public Comment
Advancing efficiency and alignment in biologics development, through product-specific methods, to support broader availability of biologics, including biosimilars, for patients
June 1, 2026
·
4 min read
Press Releases
Novelty Nobility Taps AGC Biologics to Further Develop Bispecific Drug Candidate
May 4, 2026
·
4 min read
Policy
FDA taps prior knowledge to expedite cell and gene therapy development
A year of significant policy change at the FDA brought momentum and scrutiny into the new year. As 2026 gets underway, biopharma companies are responding to sweeping vaccine changes while concerns surface about the politicization of the agency.
June 3, 2026
·
12 min read
·
BioSpace Editorial Staff
Press Releases
Nephrodite’s Holly™ Implantable Continuous Dialysis System Awarded Selection into FDA’s TAP to Accelerate Development and Patient Access
June 3, 2026
·
3 min read
Press Releases
Arna Pharma Inc. and Slate Run Pharmaceuticals Finalize Joint Venture and Launch First Brand Product
May 14, 2026
·
3 min read
FDA
FDA taps Szarama as acting CBER director as Prasad’s tumultuous tenure ends
Katherine Szarama, who has served as Prasad’s deputy at the Center for Biologics Evaluation and Research since December, joins a long list of temporary leaders at the Department of Health and Human Services.
May 1, 2026
·
2 min read
·
Heather McKenzie
Press Releases
Cala Announces FDA Clearance of its Next Generation TAPS Therapy Wearable Device for Essential Tremor and Parkinson’s Disease
April 15, 2026
·
2 min read
Press Releases
Instem Taps ex-Novartis Head of Emerging Technologies to Put Science Behind Practical AI and NAMs
April 16, 2026
·
2 min read
Press Releases
Kenox Pharmaceuticals Inc. Announces Clinical Manufacturing Readiness for Nasal and Inhaled Drug Products
March 5, 2026
·
2 min read
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