PipelineReview.com12h
Merck Announces Positive Data for V116, an Investigational, 21-Valent Pneumococcal Conjugate Vaccine Specifically Designed for Adults
Late-breaker Phase 3 STRIDE-10 trial presented as an oral presentation at European Society of Clinical Microbiology and Infectious Diseases ...
PipelineReview.com11h
Bitterroot Bio Announces Dosing of First Participants in a Phase 1, First-in-Human Study of BRB-002 in Healthy Volunteers
PALO ALTO, CA, USA and MELBOURNE, Australia I April 29, 2024 I Bitterroot Bio, a leader in developing innovative medicines in the field of cardio-immunology, ...
PipelineReview.com17h
selectION Announces Positive Results from Phase 1b Clinical Trial Evaluating si-544 in Patients with Atopic Dermatitis
SAN DIEGO, CA, USA, and MUNICH, Germany I April 29, 2024 I selectION, Inc., a clinical-stage biopharmaceutical company developing novel treatments for T-cell ...
PipelineReview.com11h
Henlius Trastuzumab Receives FDA Approval in the United States
SHANGHAI, China I April 29, 2024 I Henlius Biotech, Inc. (2696.HK) announced that the company's business partner, Accord BioPharma Inc. (the U.S. specialty ...
PipelineReview.com9h
Bavarian Nordic Initiates Rolling Submission of Biologics License Application with FDA for its Chikungunya Vaccine Candidate
COPENHAGEN, Denmark I April 29, 2024 I Bavarian Nordic A/S (OMX: BAVA) today announced that it has initiated the rolling submission process with the U.S. Food and Drug Administration (FDA) for a ...
PipelineReview.com11h
Deciphera Pharmaceuticals to be Acquired by ONO Pharmaceutical For $2.4 Billion
J.P. Morgan Securities LLC is serving as exclusive financial advisor to Deciphera and Goodwin Procter LLP is serving as legal counsel. BofA Securities is serving as financial advisor to ONO and ...
PipelineReview.com11h
NKGen Biotech Announces FDA Clearance of Investigational New Drug (IND) Application for SNK01 NK Cell Therapy in Parkinson’s Disease
NKGen advances its neurodegenerative disease program with FDA IND clearance for its Phase 1/2a SNK01 Clinical Trial in patients with Parkinson’s disease.
PipelineReview.com18h
AriBio Receives EMA Phase 3 Clinical Trial Authorisation for AR1001 in Treatment of Alzheimer’s Disease (POLARIS-AD)
SEONGNAM-SI, South Korea I April 28, 2024 I AriBio Co., Ltd. (AriBio) announced authorisation from the European Medicines Agency (EMA) for POLARIS-AD ...
PipelineReview.com18h
Longhorn Vaccines and Diagnostics Presents New Data on its Best-In-Class Infectious Disease Vaccine and Antibody Portfolio at ECCMID 2024
BETHESDA, MD & GAITHERSBURG, MD, USA I April 27, 2024 I Longhorn Vaccines and Diagnostics, a One Health company developing vaccines and diagnostic tools ...
PipelineReview.com3d
Vertex Announces European Commission Approval for KALYDECO® to Treat Infants With Cystic Fibrosis Ages 1 Month and Older
KALYDECO ® is the first and only medicine approved in the EU in this age group to treat the underlying cause of cystic fibrosis for specific mutations in ...
PipelineReview.com3d
U.S. FDA Approves Pfizer’s BEQVEZ™ (fidanacogene elaparvovec-dzkt), a One-Time Gene Therapy for Adults with Hemophilia B
NEW YORK, NY, USA I April 26, 2024 I Pfizer Inc. (NYSE: PFE)announced today that the U.S. Food and Drug Administration (FDA) has approved BEQVEZ™ ...
PipelineReview.com3d
Novel T-cell engager, CDH17 X CD3 cabotamig (ARB202) continues to explore dosing in patients with advanced gastrointestinal cancers
SEATTLE, WA, USA I April 26, 2024 I Arbele, a clinical-stage biotechnology company focused on the development of novel immunotherapies targeted for ...