Pharminent

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.

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.

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.

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.

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.

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.

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.