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European regulator decision reshapes orphan-drug landscape
Europe’s EMA CHMP backed Minoryx’s cALD orphan therapy while issuing a negative view for Zevra’s arimoclomol in Niemann-Pick disease type C, according to CHMP recommendations reported in the...
Sanofi reverses atopic dermatitis strategy tied to OX40L program
Sanofi said it is scrapping plans to file amlitelimab for atopic dermatitis, citing that the OX40-ligand monoclonal antibody would not deliver a meaningful improvement over current standard of...
CAR-T safety genetics move toward smarter engineering
A new analysis of Kite Pharma’s Yescarta (axi-cel) clinical trial patients linked genetic mutations to toxicity risk in CAR-T therapy and identified STXBP2 as a standout signal, with results...
CRISPR therapy ethics and oversight spotlighted after fatal trial
Science and Retraction Watch reporting highlighted a fatal gene-editing case in China involving an experimental brain-directed CRISPR base editor, raising questions about ethics and clinical...
Gene regulation science accelerates via NIH 4D Nucleome
NIH’s 4D Nucleome program delivered a new set of insights on how spatial chromatin structure and DNA methylation regulate gene expression across health and disease. Across eight papers published...
Biotech IPO market extends momentum with Scribe listing
Scribe Therapeutics priced and began trading its CRISPR-focused IPO, raising about $129 million at the high end of its range. The company offered 8.6 million shares at $15 each, according to the...
Codexis secures $23.1M public offering to fund enzyme tooling
Codexis announced the pricing of an approximately 16.7 million-share public offering at $1.50 per share, projecting net proceeds of about $23.1 million. The transaction is expected to close around...
New CRISPR-free cell therapy angle: off-the-shelf iPSC-derived gamma delta T cells for CRC
Kobe University researchers reported preclinical evidence that mass-producible iPSC-derived allogeneic gamma delta T cells suppressed colorectal cancer tumors in mouse xenograft models, as...
Transcripta Bio raises $24M to advance neuro programs toward the clinic
Transcripta Bio raised $24 million since its Series A to support IND-enabling studies across its portfolio and prepare for clinical readiness in autism spectrum disorder and facioscapulohumeral...
FDA panel advances compounding peptide access—tight split vote
An FDA advisory panel recommended that compounding pharmacies be allowed to produce the peptide epitalon, while narrowly voting against manufacturing emideltide. The votes followed earlier panel...
European orphan-drug decisions reshape rare disease options
EMA’s CHMP backed two orphan drugs while issuing a negative stance on a therapy already approved in the US, underscoring how evidence standards are being applied differently across regulators....
CAR-T toxicity genomics point to patient-specific risk flags
Researchers analyzing Kite Pharma’s Yescarta (axi-cel) trial data identified genetic signatures associated with CAR-T toxicity risk, with results published in Science Immunology. The study led by...
Sanofi reverses eczema filing strategy for OX40-ligand antibody
Sanofi said it will not pursue approval of amlitelimab (an OX40-ligand monoclonal antibody) in atopic dermatitis after concluding it would not deliver a meaningful improvement over current care....
Regulators narrow access for compounding peptides in FDA advisory vote
An FDA advisory panel narrowly recommended allowing compounding pharmacies to manufacture epitalon while voting against manufacturing emideltide. The separate, earlier decisions around other...
IPO window stays open for CRISPR startup Scribe
Scribe Therapeutics, a CRISPR-focused developer targeting cardiovascular and metabolic diseases, priced an upsized IPO at the top end of its range, raising about $129 million. The company began...
Biotech fundraising continues as Codexis sells equity
Codexis priced a public offering of about 16.7 million shares at $1.50 each, targeting net proceeds of approximately $23.1 million to fund working capital and R&D. The enzymatic-technology company...
Amgen and FDA dispute over Tavneos moves to a new evidentiary round
Amgen submitted a new analysis to the FDA supporting its position to keep Tavneos on the market. The latest package is intended to address a continuing regulatory dispute around the controversial...
Global approvals hit a strong H1 pace
Drug approvals through the first half of 2026 totaled 261, making it the third-best H1 on record and highlighting acceleration in June. The 64 approvals logged in June marked the highest single...
Biotech starts chasing new preclinical targets in preeclampsia via single-cell maps
A single-cell transcriptomics study of fetal-maternal tissue interfaces in preeclampsia identified distinct maternal and fetal cellular programs at different stages of gestation. The work points...
New funding supports neuro and muscle programs at Transcripta Bio
Transcripta Bio raised $24 million since its Series A to advance IND-enabling work across its pipeline and prepare for clinical execution. The company said the financing supports programs in...