Helixgate https://validator.w3.org/feed/docs/rss2.html Data Standards Program Strategic Plan and Board Center for Drug Evaluation and Research Organization Chart New Approach Methodologies (NAMs) Database of Use Case Examples New Approach Methodologies (NAMs) CDER Streamlined Nonclinical Studies and Acceptable New Approach Methodologies (NAMs) FDA Approves Therapy to Treat Ataxia in Patients with Ataxia-Telangiectasia, a Rare Genetic Disorder Project Orbis Chemistry, Manufacturing, and Controls Development and Readiness Pilot (CDRP) Program FDA approves imlunestrant in combination with abemaciclib for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer Generic Drugs Gene editing using large insertions BMS scraps Orum’s targeted degrader after reviewing Phase 1 data Ultragenyx wins FDA greenlight for first Sanfilippo therapy, priced at nearly $4M Xenon tumbles on voluntary psychiatry hold, but analysts confident in $2B epilepsy opportunity Electra lights up with $350M IPO for pivotal immune-disease drug development China plans to transform $3M biotech sector into $522B powerhouse by 2030 Home Molecular Devices and STEMCELL Technologies Team Up to Automate Organoid Research Model-Free, Pure Component Analysis Could Help Biopharma Cut Costs The Saga of Sickle Cell Disease Palomar Labs Spins Out Ariadne Bio to Advance Non-Hallucinogenic Therapy for Parkinson’s Apathy Nu-Tek Brings Topic of Raw-Material Risk to BPI Time-Restricted Eating Linked to Improved Huntington’s Disease Markers Asahi Kasei Introduces VANTIJ® SU-VFC Benchtop Virus-Filtration System GBI Biomanufacturing Set to Launch SmartScale GMP Solutions Virtual biotech company puts thousands of AI scientist agents to work on drug discovery New bioinformatics tools help identify pathogenic variants in the genome Discovery of CRISPR’s long lost ancestor may expand gene-editing toolkit Eli Lilly dishes out fresh produce to cultivate Alzheimer’s awareness Clinical trials reach a new automation inflection point Europe’s CHMP endorses slew of new medicines, including new offerings from Novo and AZ Fierce Pharma Asia—China deals safe from COINS?; Key WCLC data; Legend’s new CEO FDA approves Ultragenyx’s gene therapy Fayuvi for rare neurodegenerative disorder Bayer’s Kerendia secures FDA nod as first drug in 30 years for Type 1 diabetes-associated kidney disease Roche’s Lunsumio delivers positive confirmatory trial readout in follicular lymphoma Eli Lilly escalates oral SERD battle with FDA approval for Inluriyo, Verzenio combo FDA Expedited Investigational New Drug (IND) Pilot Program Roche, Dualitas team up to find bispecific drugs for immune diseases North Immunology joins biotech reverse merger boom with Aethlon deal Novo partners with Orbis, deepening investment in oral peptide drugs Lisata deal propels Marea’s drug pipeline to Wall Street Electra amasses $350M in biotech’s latest big IPO Ultragenyx prices Sanfilippo gene therapy at $4M; Bristol Myers shelves Orum drug This week in charts: GSK’s China deals, the $300M IPO club and selling the news Xenon shares fall following depression trial pause A national security priority: BIO pushes PAHPA reauthorization in 2026 What’s New Related to Drugs Oncology (Cancer)/Hematologic Malignancies Approval Notifications Notable Approvals | Drugs With Tepezza challenge in late-stage study, Sling draws $123M series C: Venture Report