Infectious Disease
FDA accepts Takeda’s NDA resubmission for eosinophilic esophagitis therapy
The US Food and Drug Administration (FDA) has accepted Takeda’s new drug application (NDA) resubmission for TAK-721 (budesonide oral suspension)…
Pfizer receives EC approval for LITFULO to treat severe alopecia areata
Pfizer has received marketing authorisation from the European Commission (EC) for LITFULO (ritlecitinib) for the treatment of adults and adolescents…
60 Degrees pauses Phase IIB Covid-19 trial for tafenoquine
60 Degrees Pharmaceuticals has withdrawn its investigational new drug (IND) application for ACLR8-LR, a Phase IIb study of the use…
BioNTech and CEPI partner to develop Mpox vaccine
BioNTech has entered a strategic collaboration with the Coalition for Epidemic Preparedness Innovations (CEPI) to develop messenger ribonucleic acid (mRNA)-based vaccine candidates…
Generate:Biomedicines secures $273m to advance therapeutic portfolio
Generate:Biomedicines has secured $273m in a Series C financing round to expedite its generative artificial intelligence (AI) preclinical and clinical…
Astellas to build drug production facility in Ireland
Astellas Pharma is submitting a planning application for the construction of a new drug production facility in Tralee, County Kerry,…
GARDP and Orchid Pharma enter antibiotic sublicence deal
The Global Antibiotic Research & Development Partnership (GARDP) and Indian company Orchid Pharma have entered a sublicence agreement for the production…
FDA approves Pfizer-BioNTech’s Omicron XBB.1.5-adapted Covid-19 vaccine
The US Food and Drug Administration (FDA) has approved Pfizer and BioNTech’s supplemental biologics license application (sBLA) for Omicron XBB.1.5-adapted monovalent…
EC expands indication approval for Merck’s Ebola vaccine
The European Commission (EC) has granted expanded indication approval for Merck’s Ebola Zaire vaccine, Ervebo, to include children aged one year or…
TC BioPharm and QMUL to study gamma-delta T cells for mucosal infection
Clinical stage biotechnology company TC BioPharm and Queen Mary University of London (QMUL) in the UK have announced a partnership to study…