News

PipelineReview.com18h
U.S. FDA Approves NUBEQA® (darolutamide) to Treat Patients with Metastatic Castration-Sensitive Prostate Cancer
WHIPPANY, NJ, USA I June 03, 2025 I Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved its oral androgen receptor inhibitor ...
PipelineReview.com19h
Ascletis Announces Phase III Trial of Denifanstat (ASC40), a First-in-Class, Once-Daily Oral FASN Inhibitor for Acne, Meets All Endpoints
HONG KONG, China I June 3, 2025 I Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that denifanstat (ASC40), a first-in-class, once-daily oral ...
PipelineReview.com18h
TRexBio Doses First Participant in Phase 1 Trial of TRB-061, a Novel TNFR2 Agonist for Atopic Dermatitis and Other Inflammatory Diseases
SOUTH SAN FRANCISCO, CA, USA I June 03, 2025 I TRex Bio, Inc. (“TRexBio”), a clinical-stage biotechnology company decoding human tissue immune biology to ...
PipelineReview.com19h
Roche’s Evrysdi tablet approved by European Commission as first and only for Spinal Muscular Atrophy (SMA)
BASEL, Switzerland I June 04, 2025 I Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved a label extension for ...
PipelineReview.com18h
Avenzo Therapeutics Initiates Phase 1/2 Clinical Study of AVZO-1418, a Potential Best-in-Class, Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate
SAN DIEGO, CA, USA I June 03, 2025 I Avenzo Therapeutics, Inc. (“Avenzo”), a clinical-stage biotechnology company developing next-generation oncology ...
PipelineReview.com19h
Early results from Johnson & Johnson’s trispecific antibody show promising response in heavily pretreated multiple myeloma patients
Phase 1 trial demonstrates encouraging clinical activity of investigational immunotherapy for relapsed or refractory multiple myeloma ...
PipelineReview.com19h
Camurus and Lilly enter collaboration and license agreement for long-acting FluidCrystal® incretins
LUND, Sweden and INDIANAPOLIS, IN, USA I June 3, 2025 I Camurus (NASDAQ STO: CAMX) and Eli Lilly and Company ("Lilly") have entered a collaboration and ...
PipelineReview.com18h
Daewoong Pharmaceutical Presents Phase 2 Clinical Trial Poster on ‘Bersiporocin’ at ATS 2025, Highlights Global Patient Demographics
Ongoing Phase 2 study enrolling 102 patients in the U.S. and South Korea, with more than 50% of participants identified as Asian ...
PipelineReview.com1d
Calidi Biotherapeutics Presents systemic oncolytic platform with CD55-Enhanced expression and IL-15 Superagonist Payload at ASCO Annual Meeting
SAN DIEGO, CA, USA I June 02, 2025 I Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the ...
PipelineReview.com1d
OSE Immunotherapeutics Provides Clinical Updates on Neo-Epitope Based Cancer Vaccine Tedopi® in Pancreatic Cancer and Non-Small Cell Lung Cancer
NANTES, France I June 2, 2025 I OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE), today provided clinical updates on Tedopi®, the “off-the-shelf” ...
PipelineReview.com1d
IN8bio Presents Positive Phase 1 Data of INB-200 in Newly Diagnosed GBM Demonstrating Prolonged Progression-Free Survival
NEW YORK, NY, USA I June 02, 2025 I IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta (γδ) T cell ...
PipelineReview.com1d
uniQure Provides Regulatory Update on AMT-130 for Huntington’s Disease
AMT-130 has been granted the FDA’s Regenerative Medicine Advance Therapy (RMAT) designation and Breakthrough Therapy designation, the first therapy for Huntington’s disease to receive an RMAT ...