AllSci News
Kyowa Kirin, Kura initiate Japanese Phase II for ziftomenib in relapsed/refractory NPM1-mutated AML
Kyowa Kirin and Kura Oncology have initiated a Japanese Phase II registration-directed trial of ziftomenib in adult patients with relapsed/refractory...
Insilico Medicine nominates ISM0387 as preclinical candidate from generative AI platform in United Arab Emirates
Insilico Medicine announced the nomination of ISM0387 as a preclinical candidate in the United Arab Emirates, marking what the company described as the...
AbbVie’s Rinvoq secures EMA Orphan Drug Designation for systemic sclerosis
AbbVie’s upadacitinib received orphan drug designation from the European Medicines Agency (EMA) for the treatment of systemic sclerosis on 20 April 2026,…
Grace Therapeutics receives CRL from US FDA for GTx-104 nimodipine formulation
Grace Therapeutics, Inc. disclosed that the US FDA issued a Complete Response Letter (CRL) for the company’s New Drug Application (NDA) for…
FDA approves Regeneron’s Otarmeni as first gene therapy for genetic hearing loss
The US FDA has approved Otarmeni (lunsotogene parvec-cwha), the first gene therapy for genetic hearing loss, granting Regeneron Pharmaceuticals accelerated approval for…
Mabwell's global first-in-class LILRB4/CD3 bispecific reaches IND stage in China for AML
Mabwell (688062.SH) announced on April 15, 2026 that China's National Medical Products Administration has accepted an investigational new drug application...
Repertoire Immune Medicines' RPTR-1-201 enters first clinical trial for advanced solid tumors
Repertoire Immune Medicines announced that the first participant has been dosed in a Phase I/II trial of RPTR-1-201, a TCR bispecific therapy designed to...
Connect Biopharma's rademikibart advances Phase II asthma and COPD exacerbation trials
Connect Biopharma (Nasdaq: CNTB) reported that an independent Data Monitoring Committee has reviewed interim efficacy data from its Phase 2 Seabreeze STAT...
Janux Therapeutics' masked bispecific T cell engager enters Phase I for mCRPC
Janux Therapeutics, the San Diego-based NASDAQ-listed biopharmaceutical company (ticker: JANX), has initiated a first-in-human Phase I clinical trial of...
Maze Therapeutics prices USD 150m public offering for kidney and metabolic disease programs
Maze Therapeutics (NASDAQ: MAZE), a clinical-stage biopharmaceutical company based in South San Francisco focused on kidney and metabolic diseases, has...
Intercept Pharma terminates Phase II trial of farnesoid X receptor agonist INT-787 in severe alcohol-associated hepatitis
Intercept Pharmaceuticals has terminated its Phase II proof-of-concept trial of INT-787, a selective farnesoid X receptor (FXR) agonist, in severe...
FDA approves Sanofi and Regeneron’s Dupixent for chronic spontaneous urticaria in children aged two to 11 years
The US FDA approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria in children aged two to 11 years, marking the…
China Medical System submits NDA in China for IL-4Ralpha mAb comekibart in seasonal allergic rhinitis
China Medical System submits NDA for long-acting IL-4Rα antibody in seasonal allergic rhinitis
Belite Bio initiates NDA submission for tinlarebant in Stargardt disease type 1
Belite Bio has initiated a rolling New Drug Application (NDA) submission to the US FDA for tinlarebant (LBS-008), an oral investigational therapy targeting...
Kivu Bio's CEACAM5-directed ADC KIVU-305 enters Phase I for solid tumors
Kivu Bioscience initiates first-in-human Phase I trial of KIVU-305, a CEACAM5-directed ADC, in adults with locally advanced or metastatic solid tumors, with...
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