AllSci News
FDA clears path for Voxzogo's conversion from accelerated to traditional approval in achondroplasia
The US FDA has accepted BioMarin Pharmaceutical Inc.'s (Nasdaq: BMRN) supplemental New Drug Application (sNDA) for Voxzogo (vosoritide) seeking full...
AB Science narrows pipeline to AML and ALS programs, discontinues three suspended studies
France-based AB Science SA (Euronext: AB) is narrowing its clinical focus to two programs — AB8939 in relapsed/refractory acute myeloid leukemia and...
Apnimed files for Nasdaq IPO with NDA-stage sleep apnea therapy under FDA review
Cambridge, Massachusetts-based Apnimed, Inc. (Nasdaq: APMD) filed for an IPO on July 10, 2026, seeking a Nasdaq listing for a company whose sole clinical...
Zhaoke flips regional license into global ownership of late-stage myopia drop NVK002
Zhaoke Ophthalmology converts regional licensee status into global IP ownership of a late-stage myopia drop, leaving originator Nevakar with only a...
Eisai data support plasma tau tangle biomarker as pharmacodynamic readout for anti-tau therapy
Eisai's etalanetug reduced a tau tangle-specific plasma biomarker by more than 90% at nine months in patients with dominantly inherited Alzheimer's disease,...
Veraxa taps Ardigen AI to identify dual-target combinations for conditional cancer therapies
Veraxa Biotech AG (Nasdaq: VRXA) and Poland-based Ardigen S.A. announced an AI drug discovery collaboration to support target pair selection across Veraxa’s…
Ocugen expands OCU400 gene therapy footprint with MENA licensing deal ahead of Phase III readout
Ocugen (Nasdaq: OCGN) has signed a binding term sheet to license OCU400, its Phase III modifier gene therapy for retinitis pigmentosa, to Kuwait-based Roots...
Hemab reports early bleeding reduction with subcutaneous HMB-002 in Von Willebrand disease
Hemab Therapeutics (Nasdaq: COAG) presented Phase I/II data from its HMB-002 program in Von Willebrand Disease at the ISTH 2026 Congress, reporting...
Novo Nordisk's denecimig maintains low bleeding rates in long-term hemophilia A extension study
Novo Nordisk (Nasdaq: NVO) reported interim data from the FRONTIER4 long-term extension study at the ISTH Congress in Paris this week, showing that...
Amydis secures USD 1.1m NIH award to develop retinal imaging for TDP-43 detection
Amydis, a La Jolla, California-based diagnostics company, has received a USD 1.1 million NIH R44 Phase II SBIR award from the National Institute on Aging to...
FDA issues second manufacturing-related CRL for Elevar-Hengrui HCC combination
New Jersey-based Elevar Therapeutics, a majority-owned subsidiary of HLB Co., Ltd., announced that the US FDA issued a Complete Response Letter (CRL)…
Acta restarts first-in-human development of likely Alzheimer's gamma-secretase modulator with streamlined Phase I study
Acta Pharmaceuticals has registered a Phase I first-in-human clinical trial of GSM-779690T, an investigational compound, in healthy adults. The randomized,...
Insilico Medicine expands CNS pipeline with CMS with USD 177m in new biobuck commitments
Insilico Medicine (HKEX: 03696) and China Medical System Holdings Limited (CMS, HKEX: 867; SGX: 8A8) have announced an additional drug development collaboration…
Antengene pockets USD 60m from UCB as it pivots to monetizing proprietary TCE platform
Antengene Corporation Limited (HKEX: 6996) has confirmed receipt of the USD 60 million upfront payment from UCB under their worldwide exclusive license...
FDA expands Keytruda-Padcev combo to all muscle-invasive bladder cancer patients regardless of cisplatin eligibility
The US FDA approved both Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), each combined with Padcev (enfortumab vedotin-ejfv), as perioperative…
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