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Regulatory policy: PDUFA shifts toward reward-based ‘America First’
A policy shift would move the U.S. FDA from a punitive first-in-human fee structure toward a reward-based approach under reauthorized PDUFA. The change would reduce certain fees for domestic...
FDA review pipeline: Telix receives acceptance for glioma imaging NDA
The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), a radiolabeled glioma imaging agent used to characterize progressive or recurrent...
Biotech financing: DeepCyte launches with seed funding for single-cell toxicity prediction
DeepCyte launched with $1.5 million in seed funding to commercialize single-cell drug toxicity prediction, betting that single-cell metabolomics can improve how biopharma evaluates safety and...
Drug platform deals: Gilead and Roche expand protein-degrader bets
Gilead exercised its option to exclusively license Kymera Therapeutics’ KT-200, a preclinical oral CDK2 molecular glue degrader, adding a new degrader program to Gilead’s oncology pipeline. The...
Clinical development: Mezagitamab shows platelet gains in Phase 2 ITP trial
Mezagitamab produced clinically meaningful platelet count increases in a Phase 2 trial for immune thrombocytopenia, according to the reported findings. The antibody approach targets the underlying...
Oncology mechanisms: Novel “don’t eat me” signal identified in AML
Researchers from Mass General Brigham, Dana-Farber Cancer Institute, and the Broad Institute identified a new immune evasion mechanism in acute myeloid leukemia involving CD43, described as a...
Diagnostics & infrastructure: FairJourney Bio opens cryo-EM structural biology facility in San Diego
FairJourney Bio opened a new cryo-electron microscopy (cryo-EM) structural biology facility in San Diego, upgrading its ability to generate atomic-resolution structures directly inside its...
Biopharma funding environment: First-quarter financing rebound and market signals
Biopharma financing rebounded in Q1 2026, with total financings reaching $22.82 billion—about 74% higher than Q1 2025—after a weaker 2025. The figures suggest improved access to capital for...
FDA rejection of Replimune melanoma therapy (RP-1)
The FDA again rejected Replimune’s oncolytic virus therapy RP-1 for advanced melanoma, issuing a second complete rejection tied to unresolved questions about the study results. The decision...
Oricell pre-IPO financing to advance solid-tumor CAR-Ts
Oricell Therapeutics closed a $110 million pre-IPO round to expand its global footprint and push forward its GPC3-targeted autologous CAR-T program, Ori-C101, toward registrational trials in...
Antibody platform expansion: FairJourney Bio opens cryo-EM facility in San Diego
FairJourney Bio opened a new cryo-electron microscopy structural biology facility in San Diego, expanding its U.S. capacity and integrating atomic-resolution structure work directly into its...
FDA regulatory pathway for Telix imaging agent (Pixclara/TLX101-Px)
The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine), a radiolabeled imaging agent for characterizing progressive or recurrent glioma in both adults...
Funding: Stipple Bio emerges with $100M Series A for ADC pipeline
Stipple Bio stepped out of stealth with an oversubscribed $100 million Series A to advance its lead antibody-drug conjugate candidate, STP-100, expected to enter clinical studies in early 2027....
Biotech financings: Realta secures additional $40M for HIE therapy
Realta Life Sciences raised an additional $40 million in the final tranche of its Series A, bringing total funding to more than $150 million. The company is developing a treatment for hypoxic...
Protein degradation partnerships: Gilead and Roche deepen degrader bets
Gilead exercised its option to exclusively license Kymera Therapeutics’ KT-200, an oral CDK2 molecular glue degrader, extending a growing wave of targeted protein degradation investments. The...
Clinical updates: mezagitamab Phase 2 data in immune thrombocytopenia
A Phase 2 trial reported that mezagitamab, an investigational antibody, significantly increased platelet counts in patients with immune thrombocytopenia (ITP). The study positions mezagitamab as a...
CAR-T in autoimmune disease: durable remission case after five years
Five years after an early lupus CAR-T breakthrough case, clinicians and researchers highlighted that the patient remains in remission and continues working at the clinic where she was treated. The...
New AI+protein platform: drug discovery tools designed with diffusion models (YuelDesign suite)
University of Virginia researchers built a diffusion-model drug design suite dubbed YuelDesign, YuelPocket, and YuelBond, aimed at tailoring drug molecules to specific protein targets while...
FDA fires second CRL at Replimune’s melanoma virus therapy
The FDA has rejected Replimune Group’s oncolytic virus therapy for advanced melanoma again, issuing a second complete response letter (CRL) for RP-1 (vusolimogene oderparepvec) after the company...
Oricell books $110M pre-IPO round for GPC3 solid-tumor CAR-T
Oricell Therapeutics secured more than $110 million in a pre-IPO financing to advance its lead solid-tumor CAR-T program targeting GPC3, a protein enriched on liver cancer cells. The company said...