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Category: Impacting News

The FDA Advisory Committee Will Soon Review the NDA of Amylyx Pharmaceuticals' Product AMX0035 for ALS

On September 7th the FDA Will Review Amylyx Pharmaceuticals NDA for ALS Treatment Amylyx Pharmaceuticals ( AMLX ) announced that the U.S. FDA Peripheral and Central Nervous System Advisory Committee ( PCNSDAC ) will reconvene to review the New Drug...

August 11, 2022

Kazia Therapeutics Announces Phase II/III Clinical Trial Results for Paxalisib in Glioblastoma

Kazia Therapeutics in the NEWS Sydney, July 10, 2024, Kazia Therapeutics Limited ( KZIA ) - an oncology-focused drug development company, is pleased to announce results from GBM-AGILE, a phase II/III study that included an evaluation of paxalisib versus standard...

July 11, 2024

Important Data Will Be Presented by Regenxbio on August 30th

Regenxbio to Present Important Data Regenxbio ( RGNX ) will present important material at the Society for the Study of Inborn Errors of Metabolism Annual Symposium, taking place in Germany from August 30 through September 2, 2022. The presentations are...

August 23, 2022

Pliant Therapeutics: Positive Long-Term Data from INTEGRIS-PSC Phase 2a Trial of Bexotegrast

Pliant Therapeutics Pliant Therapeutics is a late-stage biopharmaceutical company focusing on the discovery and development of novel therapeutics for the treatment of fibrotic diseases. Pliant's lead product candidate, bexotegrast ( PLN-74809 ), is an oral, small molecule, dual selective inhibitor...

July 16, 2024

Fate Therapeutics: Improving on Cellular Therapies

Fate Therapeutics: Developing Next Generation Cellular Therapies Fate Therapeutics ( FATE ) is a clinical-stage biopharmaceutical company developing first-in-class improved cellular immunotherapies for cancer. Fate Therapeutics uses its proprietary induced pluripotent stem cell ( iPSC ) product platform in clinical development...

August 25, 2022

Ionis Pharmaceuticals Announces Positive Detailed Results from the HALOS Study of ION582

Ionis Pharmaceuticals in the NEWS Yesterday, July 22, 2024, Ionis Pharmaceuticals ( IONS ) announced positive results from the completed multiple ascending dose ( MAD ) portion of the Phase 1/2 open-label study of ION582 in people with Angelman syndrome...

July 23, 2024

Viking Therapeutics Reports Promising News

Viking Therapeutics Viking Therapeutics is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage...

July 25, 2024

TG Therapeutics: Promising Investigational Monoclonal Antibody Ublituximab for Relapsing Form of M.S.

TG Therapeutics Results Published in NEJM TG Therapeutics ( TGTX ) results from the ULTIMATE I & II Phase 3 trials evaluating the firm’s investigational monoclonal antibody product ublituximab in patients with relapsing forms of multiple sclerosis ( RMS )...

August 31, 2022

Anavex Life Sciences: Phase IIb/III Trial Results of Blarcamesine Presented at Alzheimer's Association Conference

Anaves Life Sciences Trial Results of Blarcamesine Anavex Life Sciences ( AVXL ) presented comprehensive results from a Phase IIb/III study showing that blarcamesine (ANAVEX®2-73), once daily orally, significantly slowed clinical decline in people with early Alzheimer's disease ( AD...

July 29, 2024

Adaptimmune Therapeutics: A First Approved Treatment of Unresectable or Metastatic Synovial Sarcoma

Adaptimmune Therapeutics Adaptimmune Therapeutics plc ( ADAP ) announced that the U.S. FDA has accelerated the approval of TECELRA® for the treatment of adults with unresectable or metastatic synovial sarcoma who received prior chemotherapy, and are HLA-A*02:01P, -A*02:02P, -A*02:03P, or...

August 2, 2024

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