Helixgate https://validator.w3.org/feed/docs/rss2.html STAT+: Despite Novo drug’s failure, cardiologists say they will still pursue anti-inflammatories STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy STAT+: BIO joins the legal fight against Medicare pilot that ties drug prices to peer countries STAT+: Why the latest heart drug failures should make us all more skeptical of AI hype FDA approves belantamab mafodotin-blmf for relapsed or refractory multiple myeloma FDA approves amivantamab and hyaluronidase-lpuj for subcutaneous injection FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years and older with GEP-NETS FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer FDA approves isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma FDA approves irinotecan liposome for first-line treatment of metastatic pancreatic adenocarcinoma FDA approves inotuzumab ozogamicin for pediatric patients with acute lymphoblastic leukemia FDA approves inavolisib with palbociclib and fulvestrant for endocrine-resistant, PIK3CA-mutated, HR-positive, HER2-negative, advanced breast cancer FDA approves erdafitinib for locally advanced or metastatic urothelial carcinoma FDA approves ensartinib for ALK-positive locally advanced or metastatic non-small cell lung cancer FDA approves durvalumab for limited-stage small cell lung cancer FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma FDA approves axatilimab-csfr for chronic graft-versus-host disease FDA approves atezolizumab and hyaluronidase-tqjs for subcutaneous injection FDA approves amivantamab-vmjw for EGFR exon 20 insertion-mutated non-small cell lung cancer indications FDA approves amivantamab-vmjw with carboplatin and pemetrexed for non-small cell lung cancer with EGFR exon 19 deletions or L858R mutations FDA approves alectinib as adjuvant treatment for ALK-positive non-small cell lung cancer FDA approves niraparib and abiraterone acetate plus prednisone for BRCA2-mutated metastatic castration-sensitive prostate cancer FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer Rezera proposes IPO terms amid volatile NASDAQ conditions: Public Equity Report Post-election pricing outlook: stormy with a chance of compromise China’s first-in-class deals grow as U.S. investment curbs loom — a BioCentury podcast Why Glycosylation Control Is No Longer a Secondary Concern in the Development of Complex Biologics Novartis Confirms Nine Cases of Tumors in Children Treated with Gene Therapy Zolgensma The Aging Proteome: Clocks, Cohorts, and Clinical Trials J&J’s Rybrevant Faspro moves beyond lung cancer with FDA nod UK pilots shorter NICE appraisal for new medicines Inflammation-focused Rezera sets terms for IPO Technique that spots tRNAs in action could accelerate drug development for inherited diseases AI points researchers toward new disease targets hidden in mitochondria STAT+: New tumor cases show common gene therapy tool can come with risk STAT+: Pharmalittle: We’re reading about a Novartis gene therapy, faster U.K. drug reviews, and more How to turn a BIO-Europe meeting into a lasting partnership STAT+: Amgen’s Repatha linked to fewer heart attacks The end of MAHA?; Inovio’s big FDA win Regulatory lessons from FDA review of approved AAV gene therapies Decision quality in biopharma portfolio renewal Sarepta’s new CEO confident in clinical execution as DMD competitors close in Forge’s Piteri-Molina on AI, Ohio and what’s next for gene therapy manufacturing Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November Verdicts for Summit/Akeso, Capricor, Vertex mark FDA’s stacked November Agios axes 100-plus R&D roles while awaiting FDA decision Moderna enjoys stable vaccine sales thanks to global COVID uptake Agios axes 100-plus R&D roles while awaiting FDA decision Home