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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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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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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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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Vico Therapeutics Begins Twice‑Yearly Dosing of VO659 in Phase 1/2 Trial for Huntington’s Disease and Spinocerebellar Ataxias

As reported in Business Wire, Vico Therapeutics has initiated patient dosing in an expanded cohort of its Phase 1/2a clinical study evaluating VO659, an antisense oligonucleotide (ASO) designed to target…

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First Patient Dosed in Phase 3 CLARITY Trial Evaluating Solriamfetol for MDD With Excessive Daytime Sleepiness

As published in Sleep Review Magazine, Axsome Therapeutics has officially begun dosing patients in its Phase 3 CLARITY trial, a study designed to evaluate solriamfetol as a potential treatment for…

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Harness Therapeutics Advances First‑in‑Class Huntington’s Disease Candidate HRN001 and Forms Expert Clinical Advisory Board

As reported on PharmaBiz, Harness Therapeutics has selected HRN001 as its lead therapeutic candidate for Huntington’s disease (HD), marking a major milestone for the company as it prepares to transition…

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Datroway Receives U.S. Priority Review for First‑Line Treatment of Metastatic Triple‑Negative Breast Cancer

AstraZeneca and Daiichi Sankyo’s antibody‑drug conjugate Datroway (datopotamab deruxtecan) has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for use as an initial treatment in adults…

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CHMP Backs Novo Nordisk’s Semaglutide for MASH, Opening Door to EU Approval

As reported on MedicalXpress, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for several therapies this cycle, including a conditional endorsement…

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Aucta Pharmaceuticals Launches PYQUVI, Expands Branded‑Generic Portfolio in Rare Disease Care

As reported on the Manila Times, Aucta Pharmaceuticals has officially introduced PYQUVI™ (deflazacort) oral suspension 22.75 mg/mL, marking the company’s entry into the U.S. commercial branded‑generic market. The therapy, released…

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Datroway Receives U.S. Priority Review for First‑Line Treatment of Metastatic Triple‑Negative Breast Cancer

In a recent statement by AstraZeneca, AstraZeneca and Daiichi Sankyo’s antibody‑drug conjugate Datroway (datopotamab deruxtecan) has been granted Priority Review by the U.S. Food and Drug Administration (FDA) for use…

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Moderna and Recordati Partner on mRNA‑3927 for Propionic Acidemia: Clinical Development Advances Toward Pivotal Readout

As reported on BioSpace, Moderna has entered a commercialization agreement with Recordati valued at up to $160 million to support late‑stage development and future market introduction of mRNA‑3927, an investigational…

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New Immunotherapy Strategy Targets Tumor ‘Bodyguards,’ Shows Powerful Results in Preclinical Cancer Models

As reported on ScienceDaily, a research team at the Icahn School of Medicine at Mount Sinai has unveiled a novel immunotherapy that tackles metastatic cancer by attacking the tumor’s protective…

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FDA Places Clinical Holds on REGENXBIO’s MPS Gene Therapy Programs After Tumor Detected in Trial Participant

As reported on drugs.com, REGENXBIO has disclosed that the U.S. Food and Drug Administration has halted clinical testing of its investigational gene therapies RGX‑111 and RGX‑121, both being developed for…

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