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PTC Therapeutics, Inc.

http://www.ptcbio.com/

Latest From PTC Therapeutics, Inc.

First Four Members Of US FDA’s Newest Advisory Committee Are Mostly Rookies

Most of the new Genetic Metabolic Diseases Advisory Committee members have little FDA or advisory committee experience, except the new industry representative, with six more voting slots still to fill before its first meeting.

Rare Diseases Advisory Committees

Cancer, Gene Therapy Top US FDA’s Second Half 2024 User Fee Calendar

Novel agents in immuno-oncology headline the drug center’s upcoming goal dates, while gene therapies make up most of the biologic center’s workload.

US FDA Performance Tracker Approvals

Accelerated Approval: ALS Drug Could Test New Congressional Directive On Survival

Clene leadership spoke with the Pink Sheet about its push for accelerated approval for its ALS nanoparticle treatment. A new nudge from Congress asking the US FDA to consider survival data in accelerated approval could help.

Drug Approval Standards FDA

First Nasal Adrenaline Spray Among 10 Products Heading For EU-Wide Approval

The June meeting of the European Medicines Agency's human medicines committee brought mixed fortunes for companies. 10 new products were recommended for pan-EU approval, two drugs were rejected, while the conditional approval of one drug is set to be revoked. PTC Therapeutics again faced disappointment regarding its Duchenne muscular dystrophy drug Translarna, but has vowed to fight back.

Europe Drug Review
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Company Information

  • Industry
  • Biotechnology
  • Pharmaceuticals
  • Biotechnology
    • Antisense, Oligonucleotides
    • Drug Discovery Tools
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      • Genomics-Proteomics
  • Other Names / Subsidiaries
    • Agilis Biotherapeutics, Inc.
    • Censa Pharmaceuticals Inc.
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