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TG Therapeutics, Inc.

https://www.tgtherapeutics.com/

Latest From TG Therapeutics, Inc.

US FDA Has History Of Pushing Sponsors On Confirmatory Trials … Sometimes

Even before a new law granted FDA authority to require studies be underway before accelerated approval, review divisions have, in some cases, given sponsors years of advance notice on expectations around study timing, according to a Pink Sheet review of NME accelerated approvals.

Pink Sheet Perspectives Review Pathway

Genentech’s Polivy To Get US FDA Panel Review For First-Line Treatment Of Diffuse B-Cell Lymphoma

But company says the 9 March advisory committee meeting ‘currently does not have any impact’ on Polivy’s existing accelerated approval indication in the third-line setting; agency may be seeking input on the robustness of the progression-free survival benefit and uncertainties about overall survival data in the POLARIX Phase III trial in previously untreated DLBCL.

United States Advisory Committees

Next Potential Big ADC Player? Korean Firms Take It Up A Notch

Scrip takes a look at the increasingly competitive landscape of Korean antibody-drug conjugate developers, which are now vying to catch up with their global rivals in the hot area.

South Korea Research & Development

With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

Approvals Drug Review
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Company Information

  • Industry
  • Pharmaceuticals
  • Biotechnology
    • Gene Therapy, Cell Therapy
    • Large Molecule
      • Antibodies
  • Other Names / Subsidiaries
    • Ariston Pharmaceuticals, Inc.
    • Atlantic Pharmaceuticals, Inc.
    • Atlantic Technology Ventures, Inc.
    • Manhattan Pharmaceuticals, Inc.
    • Manhattan Research Development, Inc.
    • Tarpan Therapeutics, Inc.
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