Study: Engineered Immune Cells and Targeted Treatments May Slow the Spread of Triple-Negative Breast Cancer

CAR T- cells are immune cells that are engineered in a laboratory to attack cancer. The therapy has worked as planned for certain blood cancers but to a lesser degree…

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Breakthrough DNA Repair Inhibitor Advances Rapidly Toward Clinic: Artios’ ART6043 Earns FDA Fast Track Status for Resistant Breast Cancer

Artios Pharma has achieved a significant milestone in cancer treatment development with the U.S. Food and Drug Administration's granting of Fast Track designation to ART6043, a potentially first-in-class DNA polymerase…

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Bristol Myers Squibb Reports Positive Phase 3 Data for Mezigdomide-Based Oral Regimen in Relapsed or Refractory Multiple Myeloma

As reported on drugs.com, Bristol Myers Squibb (BMS) has announced encouraging interim results from the Phase 3 portion of the SUCCESSOR-2 clinical trial evaluating oral mezigdomide in patients with relapsed…

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Roche’s Phase III persevERA Trial of Giredestrant Misses Primary Endpoint in Advanced ER-Positive Breast Cancer

As covered on PharmaBiz, Roche has reported topline results from the phase III persevERA Breast Cancer study, which evaluated the oral selective oestrogen receptor degrader (SERD) giredestrant in combination with…

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Daiichi Sankyo Advances Enhertu for High-Risk Breast Cancer: New Hope After Neoadjuvant Therapy

Daiichi Sankyo has taken a significant step forward in expanding treatment options for early-stage breast cancer patients by submitting a supplemental New Drug Application (sNDA) to Japan's Ministry of Health,…

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Accelerated Pathway Opens for GSK’s Pruritus Solution in China’s Rare Liver Disease Population

GlaxoSmithKline has achieved a significant regulatory milestone as China's National Medical Products Administration granted priority review status to linerixibat, an investigational treatment for cholestatic pruritus associated with primary biliary cholangitis.…

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FDA Grants Priority Review to Enhertu for HER2‑Positive Early Breast Cancer With Residual Disease

As reported on PharmaBiz, the US Food and Drug Administration (FDA) has accepted and granted Priority Review to AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab…

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Gene Therapy Setback: REGENXBIO’s RGX-121 Faces Regulatory Hurdles in Ultra-Rare Disease Treatment

REGENXBIO encountered a significant regulatory obstacle when the FDA issued a complete response letter regarding its biologics license application for RGX-121, an investigational gene therapy targeting mucopolysaccharidosis II (MPS II),…

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Serina Therapeutics Begins First-in-Patient Dosing in Phase 1b Trial of SER‑252 for Advanced Parkinson’s Disease

As reported on RTT News, Serina Therapeutics has initiated patient dosing in its Phase 1b registrational study of SER‑252, marking a significant milestone for the company’s lead investigational therapy for…

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From Psychiatric Bind to Clinical Solution: The VMAT2 Revolution in Treating Tardive Dyskinesia

Tardive dyskinesia represents one of medicine's cruelest ironies: a side effect born from the very medications designed to restore psychiatric health. For generations, treating this involuntary movement disorder meant accepting…

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Breaking New Ground: Milsaperidone Offers Patients a Fresh Option for Serious Mental Illness

Vanda Pharmaceuticals has achieved a significant regulatory milestone with the FDA's approval of milsaperidone (Bysanti), a newly designated atypical antipsychotic medication poised to help adults battling schizophrenia and acute bipolar…

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FDA Escalates Scrutiny of GLP‑1 Compounders as Industry Reports Key Clinical and Regulatory Updates

As reported by BioPharmaDive, he Food and Drug Administration (FDA) has intensified its oversight of companies marketing compounded GLP‑1 therapies, while Intellia Therapeutics, United Therapeutics, Merck & Co., and federal…

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Aardvark Pauses Late‑Stage Prader–Willi Trial After Cardiac Signals Emerge

As reported on BioPharmaDive, Aardvark Therapeutics has halted dosing and enrollment in its late‑stage HERO trial for ARD‑101, a first‑in‑class treatment candidate for Prader–Willi syndrome (PWS), following the discovery of…

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Breaking New Ground: FDA Green-Lights Novel Breast Cancer Treatment Targeting Treatment-Resistant Tumors

The landscape of advanced breast cancer treatment is shifting. Genentech's filing acceptance of giredestrant, an experimental oral medication, represents a pivotal moment for thousands of women grappling with a particularly…

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