Two of Intellia Therapeutics’ clinical trials that had been on hold since October 2025 have now been released by the FDA. The Agency initially issued the holds due to reports…
Editor's Note: This article was originally written and submitted to us by Regina Portnoy. When people think about leadership in clinical research, they often think about timelines, enrollment goals, budgets,…
As reported on Fierce Pharma, Huyabio has reported encouraging Phase 3 results for its investigational oral HDAC inhibitor, HBI-8000, when used alongside Bristol Myers Squibb’s immunotherapy Opdivo (nivolumab) in patients…
As reported on PharmaBiz, AtaiBeckley has announced a key milestone in the development of its investigational depression therapy, VLS-01, with the final participant now dosed in the company’s Phase 2b…
As covered by Fairfax Times, Novo Nordisk has reported encouraging long-term findings for its investigational hemophilia A therapy denecimig (Mim8), with interim results from the Phase 3 FRONTIER4 extension study…
As reported on MedCity News, the U.S. Food and Drug Administration (FDA) has issued draft guidance encouraging the thoughtful use of Bayesian statistical approaches in clinical trials, marking a notable…
As reported on BioSpace, the U.S. Food and Drug Administration (FDA) has granted priority review to BridgeBio Pharma’s investigational therapy, BBP-418, marking a key regulatory milestone for a condition that…
As reported on PharmaBiz, Regenxbio has announced encouraging topline findings from the pivotal Phase III portion of its ongoing AFFINITY DUCHENNE clinical program evaluating RGX-202, an investigational gene therapy for…
Enpatoran offers hope for millions suffering from lupus skin manifestations Pharmaceutical company Merck KGaA has announced a significant milestone in lupus treatment research. As reported by Business Wire, the first…
Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to IMAAVY® (nipocalimab-aahu), marking a significant milestone as the first therapy to receive this…
AstraZeneca has announced positive results from the pivotal phase III MIRANDA trial of tozorakimab, a groundbreaking first-in-class monoclonal antibody designed to treat Chronic Obstructive Pulmonary Disease (COPD). According to PharmaBiz.com,…
Cancer cachexia represents one of oncology's most overlooked catastrophes. Patients waste away, lose appetite, and deteriorate despite receiving chemotherapy, yet few treatment options exist to address this metabolic collapse. According…
Diabetic macular edema represents a silent threat to working professionals across America. The condition, which causes fluid accumulation in the macula, the eye's central focusing region, ranks as the leading…
Pancreatic cancer remains one of medicine's most formidable challenges, and recent clinical developments suggest a potential turning point. Revolution Medicines presented compelling evidence this week that its experimental drug daraxonrasib…
AskBio Inc., a gene therapy subsidiary of pharmaceutical giant Bayer AG, has taken a significant step forward in advancing treatment options for Parkinson's disease. According to PharmaBiz.com, the company announced…
Johnson & Johnson announced promising long-term efficacy and safety data for Icotyde (icotrokinra), the first and only targeted oral peptide that precisely blocks the IL-23 receptor for plaque psoriasis treatment.…
As reported on BioPharmaDive, Roche is restarting efforts to get Elevidys, a gene therapy for Duchenne muscular dystrophy (DMD), approved in Europe by launching a new global Phase 3 trial…
IDEAYA Biosciences and Servier announced promising Phase 2/3 trial results for darovasertib, a selective PKC inhibitor, combined with crizotinib in the treatment of metastatic uveal melanoma. According to BioSpace.com, the…
Sarepta Therapeutics has announced a significant regulatory milestone in its efforts to secure permanent FDA approval for two breakthrough Duchenne muscular dystrophy (DMD) treatments. As reported by BusinesWire.com, the company…
A decade of accumulated clinical experience with nusinersen has culminated in a significant regulatory advancement. According to Pharma Times Online, Biogen's newly approved high-dose Spinraza regimen represents a thoughtful evolution…
As reported on BioPharmaDive, several biopharmaceutical companies reported notable clinical and regulatory developments this week, with investor response reflecting growing confidence in both late‑stage pipelines and lifecycle management strategies. United…
Researchers have demonstrated substantial therapeutic benefits for brepocitinib, an oral tyrosine kinase 2/Janus kinase 1 inhibitor, in adults with dermatomyositis, according to findings from a Phase 3 clinical trial published…
CatalYm has initiated patient enrollment in the GDFATHER-HCC-01 trial, a Phase 2b study investigating visugromab as part of a combinatorial treatment strategy for patients with unresectable or metastatic hepatocellular carcinoma…
Phase 2 data suggest meaningful skin improvement and an acceptable safety profile As reported on Healio, litifilimab, an investigational therapy developed by Biogen, demonstrated encouraging efficacy and tolerability in patients…
Chugai Pharmaceutical Co., Ltd. announced that Roche has made the strategic decision to discontinue clinical development of GYM329 (emugrobart), an investigational anti-latent myostatin antibody, for two neuromuscular conditions: spinal muscular…
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