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MateryalIba pa
Atara Biotherapeutics: Humihingi ang Kasosyo ng FDA Type A Meeting tungkol sa tab-cel CRL
Isinumite ng Pierre Fabre Pharmaceuticals ang kahilingan para sa Type A meeting at briefing book sa FDA na tumutugon sa CRL noong Enero 9, 2026 para sa tab-cel BLA. Ang pagsusumite ay nagbibigay ng karagdagang konteksto sa pag-aaral ng ALLELE kasama ang na-update na datos ng bisa at sumusuportang datos para sa posibleng muling pagsusumite.
Mahahalagang fact
- Na-file
- Mar 3, 2026, 01:30 PM
- Kaganapan
- Iba pa
- Direksyon
- Neutral
- Kumpanya
ATRAAtara Biotherapeutics, Inc- Asset
- tabelecleucel
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
EX-99.1 2 d121575dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Atara Biotherapeutics Provides Regulatory Update on Tabelecleucel THOUSAND OAKS, California —(BUSINESS WIRE)— Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, today announced that its partner Pierre Fabre Pharmaceuticals (PFP) has submitted a request to the FDA for a Type A meeting. Pierre Fabre Pharmaceuticals, in partnership with Atara, submitted a briefing book to the FDA addressing the points from the Complete Response Letter dated January 9, 2026, providing additional context and clarification that the ALLELE study was adequate, well-contro
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