AllSci News
FDA Approves Sentynl’s Zycubo for Rare Genetic Copper Transport Disorder
The US FDA has approved Zycubo (copper histidinate), a novel subcutaneous injectable therapy developed by Sentynl Therapeutics, for treating Menkes disease in…
Boehringer Ingelheim Puts First-in-Class IL-11 Inhibitor to Phase 2 Test in IPF
Boehringer Ingelheim announced the initiation of a Phase 2a clinical trial for BI 765423, a novel monoclonal antibody targeting interleukin-11 (IL-11), in…
Shanghai Mental Health Center Launches First-in-Human Trial of Innovative SP-101 NMDA Antagonist
Researchers at Shanghai Mental Health Center have initiated a first-in-human clinical trial of SP-101, a novel intravenous non-competitive NMDA receptor antagonist designed to potentially address neuropsychiatric conditions.
FDA Approval
FDA Approves First Therapy for Rare Genetic Copper Transport Disorder The U.S. Food and Drug Adminis...
Pierre Fabre’s T-cell therapy tabelecleucel met with second FDA CRL
Pierre Fabre Pharmaceuticals revealed that a Biologic License Application (BLA) for Epstein-Barr virus (EBV) T-cell therapy tabelecleucel has been met with a…
AbbVie enters PD-1/VEGF BsAb field via RemeGen licensing deal
AbbVie (NYSE: ABBV) announced the signing of an exclusive licensing agreement with China-based RemeGen to develop, manufacture, and commercialize RC148, a novel…
Minghui Pharma puts novel B7-H4 ADC into first-in-human study
Minghui Pharmaceutical is preparing to launch a first-in-human clinical trial of MHB009C, an investigational antibody-drug conjugate (ADC) targeting advanced solid tumors. Hosted…
Merck KGaA Launches First-in-Human Trial of Ly6E-Targeted ADC in Advanced Solid Tumors
Merck Healthcare KGaA has initiated NCT07311603, a first-in-human interventional study evaluating M7437, an anti-Ly6E exatecan antibody-drug conjugate (ADC), in patients with advanced…
FDA Rejects Vanda’s sNDA for HETLIOZ in Jet Lag Disorder
Vanda Pharmaceuticals (Nasdaq: VNDA) announced receipt of a decision letter from the US FDA, indicating stating that a supplemental New Drug Application…
Immuneering posts ‘extraordinary’ early data for atebimetinib in first-line pancreatic cancer
Immuneering Corporation (Nasdaq: IMRX) reported updated Phase 2a clinical results for its oral MEK inhibitor atebimetinib (IMM-1-104) combined with modified gemcitabine/nab-paclitaxel (mGnP)…
Navigator Medicines puts OX40L/TNFα BsAbs into trials for inflammatory skin disease
New Jersey-based biotech Navigator Medicines is advancing two bispecific antibodies targeting OX40L and TNFα into clinical development, marking a significant progression in…
Arrowhead RNAi obesity candidates show early promise against obesity
Arrowhead Pharmaceuticals announced interim Phase 1/2a clinical results from its RNA interference (RNAi)-based obesity programmes, reporting encouraging weight loss and body-composition improvements…
Astellas puts novel brain delivery drug into first-in-human trial for chronic stroke recovery
Astellas Pharma is launching a pioneering first-in-human clinical trial of ASP2246, a novel therapeutic agent designed to potentially improve motor function in…
GSK’s bepirovirsen hits Phase III endpoints as potential first functional cure for hepatitis B
GlaxoSmithKline (GSK) announced positive topline results from its two pivotal Phase III B-Well 1 and B-Well 2 trials evaluating bepirovirsen, an investigational…
Alzheimer’s symptoms reversed in preclinical study targeting NAD+
A team of researchers has posted potentially paradigm shifting research in the field of Alzheimer’s disease (AD) therapy, showing for the first…
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