News and Press Releases
Cyclana Bio granted Health Research Authority approval and recruits first patients for clinical observational study in endometriosis
UK NHS grants HRA/REC approval for PEMP study with Peterborough and Cambridge hospitals Clinical observational study investigating underlying biology of endometriosis aims to uncover causal mechanisms and new druggable targets...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 19, 2026
Microbiotica Announces Positive Results from its Phase 1b Trial (MELODY-1) of MB097, a Precision Microbiome Co-Therapy in Advanced Melanoma
MB097 used in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) 18 May 2026 -- Cambridge, UK -- Microbiotica, a clinical-stage biopharma company developing a pipeline of oral precision microbiome medicines...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 18, 2026
Microbiotica Limited Chesterford Research Park Little Chesterford Cambridge CB10 1XL UK
FASENRA approved in US for hypereosinophilic syndrome
14 May 2026 -- Cambridge, UK -- AstraZeneca’s FASENRA (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 14, 2026
Neurizon Receives Ethics Approval for Phase 1 NUZ-001 Oral Liquid Formulation Study
Bellberry Human Research Ethics Committee (HREC) approves Neurizon’s Phase 1 formulation study supporting development of the NUZ-001 oral liquid formulation and continued advancement of NUZ-001 for amyotrophic lateral sclerosis (ALS)...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 13, 2026
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Enterprise Therapeutics achieves primary efficacy outcome in Phase 2 clinical trial for cystic fibrosis with novel inhaled ENaC blocker ETD001
First investigational inhaled ENaC blocker to deliver clinically relevant and statistically significant change in lung function compared to placebo Inhaled therapeutic designed to treat the 10% of people with cystic...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 12, 2026
Sussex Innovation Centre, University of Sussex, Science Park Square, Falmer, Brighton, BN1 9SB, UK
CPHI Americas 2026 unveils keynote speakers tackling pharma’s toughest challenges
11 May 2026 -- Pennsylvania, US -- Informa Markets has announced its keynote speaker line-up for CPHI Americas 2026 (June 2–4), bringing together more than 80 industry thought leaders, including...
Category: Biotechnology, Other, Pharmaceutical
Posted: May 11, 2026
U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder
29 April 2026 -- California, US -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 29, 2026
Epitopea Announces Approval of OVACT Clinical Trial Application for CryptiVax-1001 in Advanced High-Grade Serous Ovarian Cancer
Appoints Leading Oncologist Professor Susana Banerjee of The Royal Marsden as Chief Investigator 23 April 2026 -- Cambridge, UK and Montreal, Canada -- Epitopea, a transatlantic biotech developing off-the-shelf, durable, RNA-based cancer immunotherapies, today announced that it has received approval from the UK’s Medicines and Healthcare...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 23, 2026
Salisbury House, Station Road, Cambridge, Cambridgeshire, United Kingdom, CB1 2LA
IMAAVY (nipocalimab)▼shows over two years of sustained disease control in a broad population with generalised myasthenia gravis (gMG)
Through 120 weeks of follow-up, nipocalimab delivered sustained clinical improvements and reductions in total IgG in antibody-positive adult patients including anti-AChR+ and anti-MuSK+ Patients achieving sustained minimal symptom expression (MSE)...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 22, 2026
Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
PureTech Reports Positive Topline Data from Phase 1b Trial of LYT-200 in Relapsed/Refractory (R/R) High-Risk (HR) Myelodysplastic Syndrome (MDS) and R/R Acute Myeloid Leukemia (AML)
Phase 1b dataset with LYT-200 demonstrates complete responses and favorable tolerability across both R/R HR-MDS and R/R AML PureTech’s Founded Entity, Gallop Oncology, to advance LYT-200 first in R/R HR-MDS,...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 22, 2026
U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility
Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this...
Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 20, 2026
Samsung Bioepis Presents Nonclinical Data for its First Novel Antibody-Drug Conjugate Candidate SBE303 at AACR 2026
Nonclinical findings from pharmacology, pharmacokinetics, and toxicology studies support the advancement of SBE303 into clinical development with a favorable therapeutic index (TI), with its first-in-human Phase I clinical trial began...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 20, 2026
Freya Biosciences announces positive Phase 1 first-in-human data with FB301 for IVF-related embryo implantation failure
FB301 was safe and well tolerated in healthy female subjects, with all primary and secondary endpoints met Clinically meaningful microbiome modulation observed, including significant improvement up to 6-month follow-up Results...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 16, 2026
STORM Therapeutics Secures $56 Million Series C Financing and Doses First Patient in Phase 2 Sarcoma Trial of STC‑15
The proceeds will support the advancement of STC-15 in a Phase 2 study in select sarcoma indications First‑in‑class METTL3 inhibitor reprograms malignant progenitor cells by modulating mRNA methylation 16 April...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 16, 2026
Kainova Therapeutics Expands Phase I/II Trial of DT-7012, a Treg-depleting Anti-CCR8 Antibody, with First Patient Dosed in Europe
First patient dosed in France, expanding the DOMISOL study beyond Australia DT 7012 is being evaluated as monotherapy and in combination with pembrolizumab in a global clinical development program. 9...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 9, 2026
