Highlights
Merck’s Keytruda gets FDA priority review for high-risk NMIBC
The new supplemental Biologics License Application (sBLA) for Keytruda, which has been accepted by the FDA is for the
LUNAC Therapeutics-led project awarded £3.14m under Innovate UK Biomedical Catalyst Pro
The funding will be used to develop an innovative anticoagulant treatment with minimal bleeding risk, to better meet
Sensorion’s Seliforant to treat AUV fails to meet primary endpoint in phase 2b tria
SENS-111 is an orally available small molecule histamine type 4 receptor antagonist, which delivers an inhibitory eff
AstraZeneca’s Imfinzi gets FDA priority review for extensive-stage SCLC
Imfinzi holds approvals for the curative-intent setting of unresectable, stage III non-small cell lung cancer (NSCLC)
Medincell receives $19m grant for mdc-WWM programme
It aims to fund preclinical activities and a phase 1 clinical trial for the injectable six-month bioresorbable contra
WuXi ATU and GeneMedicine sign development and manufacturing agreement for oncolytic virus
This is the first international Chemistry, Manufacturing and Controls (CMC) development and manufacturing project emp
Novartis opens new cell and gene therapies facility in Switzerland
The new facility also facilitates the production of advanced and difficult-to-manufacture solid dosage forms such as
Verrica Pharmaceuticals announces FDA filing acceptance of NDA for VP-102 to treat mollusc
“There are no FDA-approved treatments currently available to patients diagnosed with molluscum, the majority of
Evofem Biosciences resubmits new drug application to US FDA for Amphora for the prevention
“Today’s submission represents a significant step forward for Evofem and for the millions of women who ar
FDA accepts Incyte’s NDA for priority review of pemigatinib to treat cholangiocarci
The NDA has been accepted for the priority review of selective fibroblast growth factor receptor (FGFR) inhibitor pem
FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo plus
The FDA has granted the application Priority Review with a Prescription Drug User Fee Act (PDUFA) goal date of May 15
Twist Bioscience announces strategic collaboration with Schrödinger for drug discovery
Under the terms of the agreement, each company will contribute their individual expertise in a highly collaborative m