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FDA opens PreCheck submissions: drugmakers can pitch faster factory builds
The U.S. Food and Drug Administration opened submissions for its PreCheck program, inviting drugmakers to apply for a pathway intended to accelerate construction of domestic drug manufacturing...
Daiichi halts next‑gen ADC development as Datroway readout slips
Daiichi Sankyo announced it is stopping internal development of a next‑generation antibody‑drug conjugate (ADC) built on a second ADC platform, and the company has again delayed a Phase 3 readout...
FDA places Regenxbio trials on hold after patient cancer case
The FDA has placed clinical holds on two Regenxbio gene therapy studies after a patient in one program developed cancer, prompting the agency to pause enrollment and dosing while it reviews safety...
Skye recovers with CB1–GLP‑1 combo: 22.3% weight loss at 52 weeks
Skye Bioscience released 52‑week interim data from the extension phase of its Phase 2a CBeyond study showing the nimacimab (peripherally‑restricted CB1 inhibitor) plus semaglutide combination...
Sanofi’s venglustat splits results: Gaucher win, Fabry failure
Sanofi reported mixed Phase 3 results for its glucosylceramide synthase (GCS) inhibitor venglustat: the drug met its primary endpoint in Gaucher disease but failed a separate Phase 3 trial in...
Trace wins IND for nerve imaging agent: first‑in‑human trial cleared
Trace Biosciences received FDA IND clearance for LGW16‑03 (Nervetrace Dx), a nerve‑specific fluorescent imaging agent, enabling a first‑in‑human study to evaluate safety and intraoperative...
Roche returns to RNA: $200M upfront, $1.5B in milestones
Roche’s Genentech unit licensed a SanegeneBio RNAi program in a deal that pays $200 million upfront and up to $1.5 billion in development and commercialization milestones. The companies said Roche...
Sanofi’s GCS inhibitor: passes Gaucher, fails Fabry
Sanofi reported mixed Phase 3 results for its glucosylceramide synthase (GCS) inhibitor venglustat: the drug met primary endpoints in a Phase 3 trial for Gaucher disease but failed a separate...
FDA places holds on Regenxbio trials after cancer case
The FDA placed clinical holds on two Regenxbio gene therapy studies after a patient in one trial developed cancer, prompting regulators to pause enrollment and dosing while safety investigations...
mRNA tactic neutralizes haemozoin block in malaria models
Researchers published in Nature Microbiology that an mRNA vaccination approach overcame haemozoin‑mediated immune suppression and restored efficacy of whole‑parasite malaria vaccines in mice. The...
Intranasal H5N1 vaccine prevents infection in rodent models
Washington University investigators developed an intranasal adenoviral‑vectored H5N1 vaccine that protected mice and hamsters from infection and transmission in preclinical studies published in...
Skye posts 52‑week interim gain for nimacimab plus semaglutide
Skye Bioscience disclosed interim 52‑week results from the extension phase of its Phase 2a CBeyond study evaluating nimacimab (a peripherally‑restricted CB1 inhibitor antibody) in combination with...
BIO tells Congress to shore up US biotech lead with tax and manufacturing incentives
The Biotechnology Innovation Organization submitted a formal statement to the House Ways & Means Trade Subcommittee urging targeted federal actions to sustain U.S. biotech leadership. BIO...
GSK exits Wave RNA‑editing program; Wave says it will advance candidate
GSK has walked away from a leading Wave Therapeutics RNA‑editing program, a move Wave characterized as reflecting its ability to advance the rare‑disease candidate more quickly outside the Big...
AI rewires CRISPR PAM specificity to widen editing targets
Researchers developed a deep‑learning framework that can reprogram protospacer‑adjacent motif (PAM) recognition for CRISPR–Cas enzymes, enabling tailored targeting specificities. The model...
FDA issues CRL to Pharming over pediatric expansion of Joenja
The FDA issued a complete response letter to Pharming, rejecting the company’s application to expand Joenja’s approval into younger pediatric patients for a rare immunodeficiency indication. The...
FDA halts Regenxbio trials: cancer case stalls gene-therapy push
The FDA has placed tests of two Regenxbio gene therapies on clinical hold after a participant in one study developed cancer, casting fresh doubt on the company’s approval prospects. MedCity News...
US vaccine advisory reconsiders all recommendations: chair signals review
The chair of the CDC’s Advisory Committee on Immunization Practices (ACIP), Kirk Milhoan, announced a comprehensive reevaluation of all U.S. vaccine recommendations, telling the New York Times the...
EU reworks drug rules: orphan developers could face earlier competition
European regulators are finalizing a package of laws that will force drugmakers to reckon with generic and biosimilar competition sooner, according to reporting on new legislation. The changes...
Nasal H5N1 vaccine prevents infection in animal tests – WashU
Washington University School of Medicine reported an intranasal adenoviral-vectored H5N1 vaccine that produced strong mucosal immunity and prevented infection in hamsters and mice, findings...