News and Press Releases
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
Moderna Receives MHRA Approval for Updated COVID-19 Vaccine Targeting SARS-CoV-2 Variant LP.8.1
The LP.8.1 vaccine is the first commercially licenced mRNA vaccine to be manufactured in the UK at the Moderna Innovation and Technology Centre in Oxfordshire The updated vaccines will be...
Category: Biotechnology, Drug Delivery, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2026
Fondazione Telethon Submits US Biological License Application for Etuvetidigene Autotemcel Gene Therapy for the Treatment of Wiskott-Aldrich Sydrome
11 March 2025 -- Milan, Italy -- Fondazione Telethon, an Italian biomedical charity focused on rare genetic diseases, announced that it has submitted the Biologics License Application (BLA) for the...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 11, 2025
Moderna Receives U.S. FDA Approval for Updated COVID-19 Vaccine Targeting KP.2 Variant of SARS-CoV-2
Spikevax 2024-2025 formula expected to be available in pharmacies and care settings across the U.S. in the days immediately following approval 22 August 2024 -- Massachusetts, US -- Moderna, Inc today...
Category: Biotechnology, Clinical Trials, Pharmaceutical
Posted: August 22, 2024
ModeX Therapeutics Leverages ProBioGen’s Expertise for Accelerated COVID-19 Antibody Development
29 May 2024 -- Berlin, Germany -- ProBioGen, a leading contract development and manufacturing organisation (CDMO), known for its innovative solutions in cell engineering and bioprocessing excellence, announces a pivotal...
Category: BioManufacturing, Biotechnology, Pharmaceutical
Posted: May 29, 2024
Veklury (remdesivir) recommended by NICE for treatment of COVID-19 in vulnerable adults and children
Remdesivir is the first antiviral treatment recommended by NICE to treat eligible children, including those with a high risk of serious illness from COVID-19 This decision secures long-term access to...
Category: Pharmaceutical
Posted: April 9, 2024
New partnership aims to advance vaccine against MERS coronavirus
CEPI to invest up to $47m to develop and stockpile a ready reserve of emergency MERS vaccine candidate, VTP-500 VTP-500 project with Barinthus Bio and University of Oxford, UK, uses...
Category: Clinical Trials
Posted: January 2, 2024
AstraZeneca reinforces commitment to protecting the most vulnerable from serious infectious diseases at IDWeek 2023
Real-world data from INFORM study demonstrate increased risk of severe COVID-19 outcomes among all individuals with immunocompromising conditions and highlight need for additional protection FluMist Quadrivalent data support the potential...
Category: Clinical Trials
Posted: October 12, 2023
PLC 1 Francis Crick Avenue Cambridge Biomedical Campus Cambridge CB2 0AA UK
Moderna Announces Positive Phase 1/2 Data from mRNA-1083, the Company’s Combination Vaccine Against Influenza and COVID-19
mRNA-1083 showed strong immunogenicity against influenza and COVID-19, with an acceptable reactogenicity and safety profile, compared to licensed standalone vaccines Company to begin phase 3 trial of mRNA-1083 in adults...
Category: Clinical Trials, Drug Discovery
Posted: October 4, 2023
Shionogi Presents New Ensitrelvir Clinical and Real-World Data Reinforcing Potential Across COVID-19 Populations at ESWI 2023
New exploratory analysis of phase 3 SCORPIO-SR study data in Asia suggests that ensitrelvir may reduce the risk of persistent and new late-onset symptoms associated with long COVID-19 over one...
Category: Clinical Trials
Posted: September 20, 2023
MODERNA RECEIVES US FDA APPROVAL FOR UPDATED COVID-19 VACCINE
Clinical data show robust immune responses across multiple circulating variants, including EG.5, FL.1.5.1, and BA.2.86 Updated vaccine to be available in pharmacies and care settings across the US in the...
Category: Clinical Trials
Posted: September 12, 2023
NIH and Exothera collaborate to produce GMP intranasal vaccine against SARS-CoV-2 for clinical phase I/II trial in Africa and US
16 August 2023 -- Maryland, US and Jumet, Belgium -- The National Institutes of Health (NIH), the US’s medical research agency, selected Exothera, a full-service Contract Development and Manufacturing Organisation...
Category: Other
Posted: August 23, 2023
MODERNA CLINICAL TRIAL DATA CONFIRMS ITS UPDATED COVID-19 VACCINE GENERATES ROBUST IMMUNE RESPONSE IN HUMANS AGAINST WIDELY CIRCULATING VARIANTS
Updated COVID-19 vaccine effectively targets EG.5, a dominant variant of concern, as well as the rapidly spreading FL 1.5.1 variant Updated vaccine expected to be available, pending approval, in coming weeks...
Category: Other
Posted: August 22, 2023
