Helixgate https://validator.w3.org/feed/docs/rss2.html GSK lays off 650 staffers amid closure of German vaccine manufacturing site Rare disease reform, CMC risk, reshoring US trials top of mind ahead of PDUFA VIII meeting FDA opens Operation TrialBlazer for applications, hoping to reshore early trials AI is changing the talent biotech companies compete to hire For many, the retirement goal posts are shifting Sling catches $123M series C for thyroid eye disease pill FDA warning letter accuses Bausch & Lomb of lacking commitment to remediation Stakeholders urge FDA to define data, treatment standards as psychedelic drugs near market FDA hears input on psychedelics, PDUFA, lung cancer’s next-gen therapies boost survival Novartis halts TREM2 targeting ALS program in 4th trial stumble in a month Deep dive: Psychedelics back on FDA’s doorstep 3 KRAS drugs to watch as the field expands Where female participation in clinical trials has caught up — and where gaps remain ‘Patients are not a renewable resource’: Rethinking rare disease R&D Sionna says good-bye to 46% of staffers, including exec Right Resin, Right Order: A Two-Step Polishing Strategy for Bispecific Antibodies Consolidating Antibody Discovery Data with an AI Platform FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development FDA Launches Expedited IND Pilot, Begins Accepting Applications FDALabel: Full-Text Search of Drug Product Labeling An America First Approach to Medical Innovation FDA Expedited Investigational New Drug (IND) Pilot Program FDA Approves Additional Information in Labeling for Kybella (Deoxycholic Acid) Injection Warning of Adverse Reactions Associated with Unapproved Use Drug Safety Communications FDA’s Drug Registration and Listing Workshop: Compliance, Regulatory and Submission Updates – 09/29/2026 FDA Pharmacy Student Experiential Program How to Apply About FDA PSEP 2026 IPO stock tracker: How newly public biotechs are performing STAT+: FDA takes applications for new program to shorten drug approval times STAT+: Pharmalittle: We’re reading about a GSK deal for a drug from China, job losses in the U.S., and more FDA signals tighter scrutiny of early-stage data from China FDA fills in blanks on expedited IND pilot Esophageal pH Monitoring Capsule Recall: Medtronic and Given Imaging Remove Esophageal pH Monitoring Capsule Delivery Device Sanofi strikes Cheplapharm deal to divest 20 older medicines as CEO pushes for innovation FDA approves first radioligand equivalent, Curium’s copycat of Novartis’ Lutathera As ‘cultural weight’ of a psychedelic approval looms, FDA hearing focuses on access and safety FDA Approves Pixclara (floretyrosine F 18) FET-PET Imaging Agent for Glioma FDA Approves Reduced Monitoring Time for First Two Doses of Imdelltra Biofrontera Announces FDA Approval of Ameluz Red Light PDT for the Treatment of Superficial Basal Cell Carcinoma FDA Approves Bexlutry (lutetium Lu 177 dotatate) for Somatostatin Receptor-Positive Gastroenteropancreatic Neuroendocrine Tumors WCLC: Lung cancer news from BioNTech, Akeso, and Roche FDA to decide on Takeda’s psoriasis blockbuster hope in Q1 GSK wagers $750m on Chimagen multiple myeloma therapy Electra sets terms for IPO, hoping to raise up to $347m STAT+: Vera kidney drug Trutakna shows strong final results in Phase 3 trial STAT+: Obesity drugmakers are testing in kids as young as 6 Axoltis misses the mark in phase 2 ALS study, but will persevere with the synthetic peptide FDA launches pilot program to speed up sluggish phase 1 trials Home