Get the Daily Brief
Latest Biotech News
FDA accelerates psychedelics reviews via priority vouchers
The FDA moved to speed reviews for three psychedelic drug programs, issuing national priority review vouchers tied to Compass Pathways’ psilocybin treatment-resistant depression program, Usona...
Regeneron wins first FDA approval for gene therapy under national priority vouchers
Regeneron’s hearing loss gene therapy Otarmeni (lunsotogene parvec) won FDA approval for a rare inherited type of hearing loss caused by otoferlin variants, becoming the first gene therapy cleared...
EU regulators back Sanofi MS drug after US safety rejection
Sanofi’s tolebrutinib program for non-relapsing secondary progressive multiple sclerosis cleared another hurdle in Europe after the FDA issued a complete response letter in the U.S. Earlier FDA...
FDA–CMS move to speed Medicare coverage decisions for breakthrough devices
The FDA and CMS launched the RAPID coverage pathway, a new mechanism intended to reduce the lag between FDA authorization of selected breakthrough medical devices and Medicare national coverage...
FDA transparency: citizen petition challenges publication of CRLs
An unnamed biopharma sponsor filed a citizen petition asking the FDA to change its approach to publicly releasing complete response letters (CRLs), arguing the disclosure process is unlawful and...
Grace Therapeutics CRL stalls aneurysmal subarachnoid hemorrhage NDA
Grace Therapeutics said the U.S. FDA issued a complete response letter for its GTx-104 NDA in aneurysmal subarachnoid hemorrhage, delaying the company’s bid to update the standard of care. The...
UCB expands neuro pipeline via Neurona Therapeutics takeover
UCB agreed to acquire Neurona Therapeutics in a deal sized at up to about $1.15 billion, aiming to broaden its neurology pipeline around epilepsy. Neurona’s lead program, NRTX-1001, is being...
Tumor profiling and diagnostics: One Biosciences chooses Albany for U.S. expansion
One Biosciences, an Institut Curie-backed startup building AI-driven single-cell profiling tools for tumor ecosystems, selected Albany, New York as its first U.S. location. The company plans a...
Biotech venture capital: Kurma Partners closes €215M fund
Kurma Partners closed its fourth and largest venture fund at €215 million, targeting investments in companies pursuing disruptive therapeutic solutions. The fund builds on Kurma’s track record,...
Ray Therapeutics secures Series B to advance optogenetic retinal gene therapy
Ray Therapeutics raised $125 million in a Series B financing to advance retinal gene therapy programs, including clinical development and commercial readiness for its lead optogenetic asset...
Regulatory approvals and label decisions
The FDA cleared Regeneron’s gene therapy Otarmeni (lunsotogene parvec) for a rare inherited form of hearing loss caused by otoferlin variants, marking the first FDA approval for a gene therapy...
EU regulatory support for Sanofi tolebrutinib after FDA rejection
Sanofi’s tolebrutinib is receiving a regulatory lift in Europe after the FDA rejected the drug due to safety concerns, according to reports. The Committee for Medicinal Products for Human Use...
Biotech financing and IPO pipelines
Avalyn Pharma moved closer to the public markets by targeting an IPO raise of about $182 million, aiming to take inhaled reformulations of approved respiratory medicines into late-stage clinical...
Gene therapy momentum: hearing loss and beyond
Beyond Otarmeni’s FDA clearance, the broader gene-therapy ecosystem continued to show momentum through manufacturing and delivery partnerships. Andelyn Biosciences and ENCell, both CMOs, announced...
Clinical data and early-phase oncology signals
At AACR 2026, multiple early-phase studies reported clinical activity across targeted and antibody-drug conjugate approaches in difficult solid-tumor settings. In one readout, zoldonrasib—an...
Biopharma partnerships and corporate transactions
CNS-focused biotech Tortugas raised substantial venture capital to advance a portfolio of neurology compounds sourced through licensing from Eisai and Hansoh. The disclosed funding totaled $106...
Retinal therapies: Ray’s Series B and late-stage clinical push
Ray Therapeutics closed a $125 million Series B to advance its retinal gene therapy pipeline, with plans for late-stage execution behind its lead optogenetic program RTx-015 for retinitis...
Diagnostics and regulatory-access acceleration
The FDA and CMS announced a new RAPID coverage pathway intended to reduce the time between FDA authorization and Medicare coverage decisions for breakthrough medical devices. Under RAPID, eligible...
AI in healthcare operations and precision medicine workflows
Tempus’ USC partnership capped another week of AI-enabled clinical infrastructure growth, but a separate development highlighted the remaining evidence gap for healthcare AI outcomes. Researchers...
Biotech policy and transparency around FDA complete response letters
A citizen petition filed by an unnamed pharma company seeks changes to the FDA’s policy of publishing complete response letters for drugs and biologics that fail to gain approval. The petition...