Pharmaceutical Technology on MSN

Lilly and Regeneron amongst first incumbents to FDA’s fast-track facility scheme

Seven pharma companies have been selected for the FDA PreCheck pilot – a framework intended to bolster the US drug supply ...
TMCnet

Satellos Receives FDA Fast Track Designation for SAT-3247 for the Treatment of Duchenne Muscular Dystrophy

SAT-3247 has now received FDA Fast Track, Orphan Drug and Rare Pediatric Disease designations for Duchenne muscular dystrophy (“Duchenne” or “DMD”) Fast Track is designed to expedite the ...

Satellos Bioscience Shares Climb After FDA Fast Track Designation

Satellos Bioscience's shares jumped Monday after the Duchenne treatment being developed by the biotechnology company received fast track designation in the U.S. In morning trading, the shares rose 12% ...
Nasdaq

MoonLake Announces FDA Fast Track Designation for Sonelokimab Palmoplantar Pustulosis (PPP) and Provides Details on Upcoming Investor Day

The Dermatology Division of the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to sonelokimab (SLK) in moderate-to-severe palmoplantar pustulosis (PPP) supported by ...
Cure Today

Pelareorep Receives FDA Fast Track Status for KRAS-Mutant Colorectal Cancer

FDA fast track designation supports development of pelareorep plus bevacizumab/FOLFIRI in 2L KRAS-mutant MSS mCRC, enabling more frequent regulatory engagement and potential accelerated pathways.
Morningstar

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

FDA Fast Track Designation granted to 4P004 for the treatment of knee osteoarthritis, recognizing the disease as a serious condition with significant unmet medical need Designation supports enhanced ...
Morningstar

Repertoire Immune Medicines Announces FDA Fast Track Designation for its Investigational Immune Medicine, RPTR-1-201

CAMBRIDGE, Mass., May 7, 2026 /PRNewswire/ -- Repertoire® Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell-targeted immune medicines, today ...
Cure Today

FDA Fast Tracks LBL-034 in Relapsed or Refractory Multiple Myeloma

LBL-034, a GPRC5D/CD3 bispecific antibody, was developed using the proprietary LeadsBody platform, featuring a unique two-to-one structure and conditional activation. Fast track designation offers ...
Seeking Alpha

FDA opens fast-track program to speed U.S. drug plant construction

The U.S. Food and Drug Administration started taking applications for its PreCheck pilot, a new effort to accelerate the construction and review of pharmaceutical manufacturing facilities in the ...
Business Insider

FDA Grants Fast Track Designation to Merakris’ MTX-001, Opening Potential Accelerated Path to Market for Venous Leg Ulcer Therapy

RESEARCH TRIANGLE PARK, N.C., June 02, 2026 (GLOBE NEWSWIRE) -- Merakris Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to MTX-001, ...
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Cocrystal Pharma shares soar after FDA grants fast track status to CDI-988

Cocrystal Pharma, Inc. COCP shares are trading higher Thursday after the company announced that it has received Fast Track designation from the FDA for its CDI-988, the first oral antiviral candidate ...