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Systematic, data-driven science coverage · Sunday, October 11, 2026
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Kazia touts 100% clinical benefit rate for paxalisib in early-stage TNBC study
Development

Kazia touts 100% clinical benefit rate for paxalisib in early-stage TNBC study

A 100% clinical benefit rate across six evaluable patients with Stage IV triple-negative breast cancer (TNBC) has emerged from an ongoing Phase Ib study of...

4d ago
Osivax pairs Phase II flu vaccine with GC Biopharma's marketed shot in combination deal
Business

Osivax pairs Phase II flu vaccine with GC Biopharma's marketed shot in combination deal

France-based Osivax and South Korea-based GC Biopharma (KRX: 006280) have announced a long-term collaboration to develop a single-injection combination...

4d ago
FDA approves Moderna's updated 2026-2027 COVID-19 vaccines for high-risk and older adults
Regulatory & Policy

FDA approves Moderna's updated 2026-2027 COVID-19 vaccines for high-risk and older adults

The US FDA has approved updated 2026-2027 formulations of both Spikevax and mNexspike (COVID-19 Vaccine, mRNA) from Cambridge, Massachusetts-based Moderna...

4d ago
Genentech taps DualityBio's DUPAC platform for multi-program ADC collaboration
Business

Genentech taps DualityBio's DUPAC platform for multi-program ADC collaboration

Genentech has licensed DualityBio's DUPAC antibody-drug conjugate payload platform in a multi-program collaboration designed to generate next-generation...

4d ago
Shingrix shows potential cardiovascular benefit in US natural experiment
Discovery

Shingrix shows potential cardiovascular benefit in US natural experiment

A large observational study exploiting a natural experiment in US vaccine policy has found that recipients of the recombinant herpes zoster vaccine Shingrix...

4d ago
AbbVie seeks EMA approval for Skyrizi subcutaneous induction in Crohn's disease
Regulatory & Policy

AbbVie seeks EMA approval for Skyrizi subcutaneous induction in Crohn's disease

AbbVie (NYSE: ABBV) has submitted an application to the European Medicines Agency (EMA) seeking approval for Skyrizi (risankizumab) subcutaneous (SC)...

4d ago
Amgen/AZ's Tezspire extends TSLP platform to eosinophilic esophagitis with Phase III win
Development

Amgen/AZ's Tezspire extends TSLP platform to eosinophilic esophagitis with Phase III win

Tezepelumab has met both co-primary and all key secondary endpoints in eosinophilic esophagitis, Amgen (Nasdaq: AMGN) and AstraZeneca reported on August 27,...

Aug 27
Graviton/Beijing Tide’s GV101 posts 86% response rate in Phase Ib cGvHD study
Development

Graviton/Beijing Tide’s GV101 posts 86% response rate in Phase Ib cGvHD study

Phase Ib/II data from New York-based Graviton BioScience Corporation's selective ROCK2 inhibitor GV101, published in Signal Transduction and Targeted...

4d ago
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TRexBio’s TNFR2 agonist shows human proof-of-mechanism in Phase I
Development

TRexBio’s TNFR2 agonist shows human proof-of-mechanism in Phase I

South San Francisco-based TRex Bio, Inc. (TRexBio) has reported positive Phase Ia results for TRB-061, a selective tumor necrosis factor receptor 2 (TNFR2)...

4d ago
Revolution lands first approval for RAS(ON) platform with Rasonque
Regulatory & Policy

Revolution lands first approval for RAS(ON) platform with Rasonque

The US FDA has approved Rasonque (daraxonrasib), the first-in-class pan-RAS inhibitor developed by Revolution Medicines (Nasdaq: RVMD), for adults with...

4d ago
Celcuity seeks to expand Revtorpyk label to PIK3CA-mutant breast cancer after beating alpelisib
Regulatory & Policy

Celcuity seeks to expand Revtorpyk label to PIK3CA-mutant breast cancer after beating alpelisib

Minneapolis-based Celcuity Inc. (Nasdaq: CELC) submitted a supplemental New Drug Application (sNDA) to the US FDA for Revtorpyk (gedatolisib), seeking...

4d ago
Cellenkos's Treg cell therapy CK0803 wins FDA fast track for ALS
Regulatory & Policy

Cellenkos's Treg cell therapy CK0803 wins FDA fast track for ALS

Houston-based Cellenkos, Inc. announced receipt of US FDA Fast Track Designation for CK0803, an allogeneic cord blood-derived T-regulatory (Treg) cell...

4d ago
EC approves Acadia's Daybu as first-ever Rett syndrome treatment in the EU
Regulatory & Policy

EC approves Acadia's Daybu as first-ever Rett syndrome treatment in the EU

The European Commission has granted marketing authorization for Daybu (trofinetide), making San Diego-based Acadia Pharmaceuticals (Nasdaq: ACAD) the first...

4d ago
Shanghai Minwei launches first human trial of ActRIIA/B antibody for obesity
Development

Shanghai Minwei launches first human trial of ActRIIA/B antibody for obesity

Shanghai Minwei Biotechnology Co., Ltd. has registered a Phase I first-in-human clinical trial of MWN110, a monoclonal antibody the company said targets...

4d ago
CSPC's PD-1/IL-15 fusion protein earns FDA Fast Track status for MSS/pMMR CRC
Regulatory & Policy

CSPC's PD-1/IL-15 fusion protein earns FDA Fast Track status for MSS/pMMR CRC

China-based CSPC Pharmaceutical Group Limited (HKEX: 01093) announced receipt of US FDA Fast Track Designation for SYS6090 (JMT108), a first-in-class...

4d ago