Helixgate https://validator.w3.org/feed/docs/rss2.html Second M&A deal for argenx gives it Unnatural Products’ macrocyclic peptide platform What the U.S. midterms mean for biopharma — a BioCentury podcast Novartis’ full HORIZON data deepen doubts about Lp(a) as a target Overton confirmation unlikely, Brenner under consideration as acting FDA commissioner Bayer bags FDA green light for stroke drug Sunharbo FDA orders blindness risk warning to GLP-1 agonist labels Hims & Hers to offer unapproved peptides to customers Third Rock in $2bn drug-hunting pact with China’s Funnel UK’s Oyster Tx rebrands and raises $60m for Alzheimer’s R&D Altimmune gears up for FDA meeting on pivotal Phase 3 trial in alcohol use disorder Bayer wins first-in-class FDA nod for blood thinner, setting stage for BMS-J&J rival Beam preps FDA run for industry-first base-edited therapy after pivotal sickle cell success Coherus cuts 30% of staffers, Gyre makes post-acquisition layoffs FDA’s rare disease framework faces its first real test in Capricor’s DMD drug Johnson & Johnson Announces New Phase 2 Nipocalimab Study Data in Sjögren’s Disease That Reveal Insights on Importance of Symptom Improvements Most Valued by Patients Novo Post Hoc Analysis Finds Wegovy 2.4 mg Was Associated with Improvements in Liver Markers in Adults with MASH with Liver Scarring and a BMI Less Than 27 kg/m<sup>2</sup> Johnson & Johnson Reports 73% PSA Response Rate with Investigational Pasritamig-Based Immunotherapy Combination in Advanced Prostate Cancer Boehringer Ingelheim’s Survodutide is the First Glucagon/GLP-1 Dual Agonist to Demonstrate a Favorable Cardiovascular Safety Profile in Global Phase III SYNCHRONIZE-CVOT Trial Alongside Significant Cardiometabolic Benefits Merck Announces Positive Results from Phase 2b Trial of Efinopegdutide in Adults with Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Stage 2-3 Fibrosis Lilly’s Foundayo (orforglipron) Significantly Reduced Obstructive Sleep Apnea Severity, Reinforcing Its Potential to Improve Health Beyond Weight Loss FDA approves pembrolizumab with chemotherapy for unresectable advanced or metastatic malignant pleural mesothelioma FDA approves pembrolizumab with chemotherapy for HER2-negative gastric or gastroesophageal junction adenocarcinoma  FDA approves belzutifan for advanced renal cell carcinoma FDA approves cabozantinib for differentiated thyroid cancer FDA approves dabrafenib with trametinib for pediatric patients with low-grade glioma with a BRAF V600E mutation FDA approves encorafenib with binimetinib for metastatic non-small cell lung cancer with a BRAF V600E mutation FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer FDA approves fam-trastuzumab deruxtecan-nxki for HER2-positive gastric adenocarcinomas FDA approves melphalan as a liver-directed treatment for uveal melanoma FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer Early-Phase IND Protocol Recommendations for Solid Tumors; Draft Guidance for Industry PDUFA and BsUFA Quarterly Hiring Updates Drugs@FDA Data Files MedWatch Alert: FDA Investigating Serious Risk of Malignancy Linked to Zolgensma Gene Therapy Eugia US LLC (f/k/a Auro Medics Pharma LLC) Issues Voluntary Nationwide Recall of Vancomycin Hydrochloride for Injection USP 1.25g/Vial-30mL (Single Dose Vial) Due to Presence of Particulate Matter Heart Pump Controller Recall: Abiomed Removes Automated Impella Controllers (AIC) MedWatch Alert: FDA Requires Safety Labeling Changes for Glucagon-Like Peptide-1 Receptor Agonists (GLP-1 RAs) Due to Potential Increased Risk of Rare But Serious Eye Condition: FDA Safety Communication Cancer drug study puts numbers to the cost of IRA’s pill penalty BioAdvance: BIO releases national action plan to strengthen US biotech leadership Johnson & Johnson Announces U.S. FDA Approval of Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer FDA Approves Sunharbo (asundexian) in Combination with Antiplatelet Therapy for Secondary Stroke Prevention STAT+: Ionis Pharmaceuticals shares plummet after slow rollout of biotech’s triglyceride-lowering drug STAT+: Gene therapy’s long-debated cancer risk materializes STAT+: FDA warns GLP-1 drugs carry potential risk of rare eye condition STAT+: FDA approves novel Bayer drug to reduce recurrence of stroke Super-Enhancer and RNA Methylation Drive Oncogenic lncRNA H19 in Esophageal Cancer Perianal Disease in Pediatric Crohn’s Disease Linked to Overall Disease Severity and Monogenic Mutations in VEO-IBD Home