AllSci News
Columbia-led trial reports 64% response rate in small Phase II for four-drug CXCR4 regimen
A quadruplet regimen combining the CXCR4 antagonist motixafortide (APHEXDA) with the anti-PD-1 antibody cemiplimab and standard chemotherapy produced a 64%...
Spinal MRI findings trigger FDA hold, derail RegenxBio’s RGX-121 filing
The FDA's clinical hold on Navsunli (clemidsogene lanparvovec-sngl [RGX-121]), an investigational adeno-associated virus (AAV) gene therapy for...
ADARx's onvuzosiran secures FDA Fast Track for twice-yearly HAE prophylaxis approach
San Diego-based ADARx Pharmaceuticals, Inc. received US FDA Fast Track Designation for onvuzosiran (ADX-324), a prekallikrein (PKK)-targeting small...
FDA fast tracks Erasca’s pan-RAS molecular glue after early pancreatic cancer responses
San Diego-based Erasca, Inc. (Nasdaq: ERAS) announced that the US FDA has granted Fast Track Designation (FTD) to ERAS-0015, an oral pan-RAS molecular glue,...
FDA accepts United Therapeutics' ralinepag NDA for PAH
The US FDA has accepted for review a New Drug Application from United Therapeutics Corporation (Nasdaq: UTHR) for ralinepag, an investigational prostacyclin...
FDA extends deramiocel review three months as Capricor narrows indication to upper limb function
The US FDA has extended the Prescription Drug User Fee Act (PDUFA) target action date for deramiocel (CAP-1002), San Diego-based Capricor Therapeutics'...
NIH backs UT Southwestern push to drug STING in autoimmune disease
UT Southwestern Medical Center has received a USD 2.57 million NIH P01 Program Project grant from the National Institute of Allergy and Infectious Diseases...
HHS seeks input on new tiers for federal vaccine recommendations
Category: Regulatory Policy | Regulatory Body: HHS | Geography: United States | Policy Instrument: Request for Information
Boehringer suspends Phase I trial of oral CNS drug after safety event
A Boehringer Ingelheim Phase I multiple rising dose trial evaluating the investigational oral CNS compound BI 3031185 has been suspended following a safety...
ACTG repurposes alendronate in bid to shrink latent HIV reservoir
The AIDS Clinical Trials Group (ACTG) is evaluating an osteoporosis treatment, a bisphosphonate approved for osteoporosis, as a latency-reversing agent in...
Moderna takes RSV/hMPV vaccine back to clinic after earlier pediatric hold
Moderna (Nasdaq: MRNA) has registered a Phase I study of mRNA-1365 (Profile 2), a bivalent mRNA vaccine targeting both respiratory syncytial virus (RSV) and...
Orum moving CD123-targeted DAC into first-in-human testing against AML
FDA clearance of an investigational new drug application for ORM-1153, a degrader-antibody conjugate (DAC) designed to deliver targeted protein degradation...
Scholar Rock withdraws EU apitegromab filing over manufacturing site issue
Cambridge, Massachusetts-based Scholar Rock (Nasdaq: SRRK) announced a series of regulatory updates on August 24, 2026, confirming that its Biologics...
Roche continues obesity shopping with USD 2.3b deal for Hanmi’s UCN2 analog
Genentech has agreed to license HM17321, a urocortin-2 (UCN2) analog developed by South Korea-based Hanmi Pharm Co., Ltd. (KRX: 128940), in a deal worth up...
Anbogen taps University of Tokyo to explore new indications for ABT-301
Taiwan-based Anbogen Therapeutics Inc. (TPEx: 7784) entered a collaborative research agreement with the Laboratory of Veterinary Surgery, Graduate School of...
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