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  • FDA grants accelerated approval to Inovio’s Voceryq for RRP
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FDA grants accelerated approval to Inovio’s Voceryq for RRP

Inovio's Voceryq wins FDA accelerated approval for recurrent respiratory papillomatosis, Fresenius signs a WuXi Bio biosimilars deal covering up to 37 candidates, and Ultragenyx's Dojolvi is cleared in the UK.
pharminent November 2, 2026

Pharminent · Daily Brief
November 2, 2026

Regulatory & Approvals

FDA grants accelerated approval to Inovio’s Voceryq for RRP
Inovio received FDA accelerated approval for Voceryq to reduce the frequency of surgery in adults with recurrent respiratory papillomatosis.
Pharmaceutical Technology →

Ultragenyx’s Dojolvi approved in the UK for LC-FAOD
Ultragenyx’s Dojolvi, a therapy for long-chain fatty acid oxidation disorders, has been approved in the UK, several years after its US approval.
Pharmaphorum →$RARE

Hutchmed and AstraZeneca file Orpathys in Europe and Japan
Orpathys, from Hutchmed and AstraZeneca, is under regulatory review in Europe and Japan for MET-driven, EGFR-mutated lung cancer, based on data presented at ESMO. The drug was filed in the US shortly before.
Pharmaphorum →$AZN

Deals & Partnerships

Fresenius signs WuXi Bio biosimilars deal spanning up to 37 candidates
Fresenius has expanded its biosimilars position through an agreement with WuXi Bio covering up to 37 candidates.
Pharmaphorum →

Pelthos and Castle Creek agree to merge in dermatology
Pelthos Therapeutics has agreed to merge with Castle Creek Biosciences to form a new biotechnology company focused on serious diseases affecting the skin.
Pharmaceutical Technology →

Business & Finance

Setara Biosciences launches with $90M and clinical-stage lead drug
Setara Biosciences has launched with $90 million and a lead small-molecule program, acquired from Actio Biosciences, targeting the rare neuromuscular disorder Charcot-Marie-Tooth disease type 2C and overactive bladder. Actio was recently acquired by Jazz Pharmaceuticals.
MedCity News →

Medical Microinstruments raises $125M in Series D financing
Medical Microinstruments (MMI) raised $125 million in Series D financing to expand the reach of its Symani Surgical System and investigate new microsurgery applications, including an experimental approach to treat Alzheimer’s disease.
MedCity News →

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