Blog
RSS FeedPosted by Michael Wonder on 24 Aug 2020
FDA may fine clinical trial sponsors that don’t report data
24 August 2020 - The US FDA has said it will penalise sponsors of clinical trials that do not report ...
Posted by Michael Wonder on 24 Aug 2020
Trump considers fast-tracking UK COVID-19 vaccine before US election
24 August 2020 - Move comes as FDA gives emergency authorisation for use of plasma from recovered patients. ...
Posted by Michael Wonder on 24 Aug 2020
FDA's convalescent plasma EUA requires all donor blood units be tested only with Ortho's COVID-19 IgG antibody test
24 August 2020 - In its August 23 Emergency Use Authorisation for COVID-19 convalescent plasma for the treatment of hospitalised ...
Posted by Michael Wonder on 24 Aug 2020
FDA approves new Kyprolis (carfilzomib) combination regimen with Darzalex (daratumumab) and dexamethasone in both once- and twice-weekly dosing regimens
20 August 2020 - Approval based on the CANDOR and EQUULEUS studies in patients with relapsed/refractory multiple myeloma. ...
Posted by Michael Wonder on 24 Aug 2020
Exelixis announces submission of supplemental new drug application to U.S. FDA for Cabometyx (cabozantinib) in combination with Opdivo (nivolumab) for advanced renal cell carcinoma
24 August 2020 - Submission based on the phase 3 pivotal CheckMate-9ER trial, which met its primary endpoint of significantly improving ...
Posted by Michael Wonder on 24 Aug 2020
Tricida receives complete response letter from the FDA for its new drug application for veverimer for the treatment of metabolic acidosis and slowing of kidney disease progression in patients with metabolic acidosis associated with CKD
24 August 2020 - Tricida announced today that it received a complete response letter from the U.S. FDA for its new ...
Posted by Michael Wonder on 23 Aug 2020
FDA issues emergency use authorisation for convalescent plasma as potential promising COVID–19 treatment, another achievement in Administration’s fight against pandemic
23 August 2020 - Today, the U.S. FDA issued an emergency use authorisation for investigational convalescent plasma for the treatment ...
Posted by Michael Wonder on 21 Aug 2020
BioMarin, Gilead drug rejections don’t signal a change in attitude at the FDA
21 August 2020 - t’s tempting to interpret the FDA’s surprise rejections of drugs from Gilead Sciences and BioMarin Pharmaceutical ...
Posted by Michael Wonder on 21 Aug 2020
BioMarin submits new drug application to U.S. FDA for vosoritide to treat children with achondroplasia
20 August 2020 - Potential first treatment for achondroplasia in the United States. ...
Posted by Michael Wonder on 20 Aug 2020
FDA approves first paediatric indication for Xeomin (incobotulinumtoxinA) for the treatment of upper limb spasticity, excluding spasticity caused by cerebral palsy
19 August 2020 - Xeomin was also granted FDA priority review for an application for paediatric sialorrhea, reinforcing Merz Therapeutics’ commitment ...
Posted by Michael Wonder on 20 Aug 2020
U.S. FDA grants rare paediatric disease designation to AmideBio’s glucagon analog for the treatment of congenital hyperinsulinism
20 August 2020 - AmideBio announced today that the US FDA Offices of Pediatric Therapeutics and Orphan Products Development granted a ...
Posted by Michael Wonder on 20 Aug 2020
Genmab announces Janssen granted U.S. FDA approval for Darzalex (daratumumab) in combination with carfilzomib and dexamethasone in relapsed or refractory multiple myeloma
20 August 2020 - Approval marks eighth U.S. FDA approval for Darzalex. ...
Posted by Michael Wonder on 20 Aug 2020
FDA approves Novartis Kesimpta (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis
20 August 2020 - Approval based on two Phase III ASCLEPIOS studies demonstrating significant reductions in risk of relapses, confirmed disability ...
Posted by Michael Wonder on 20 Aug 2020
Polaryx Therapeutics receives FDA fast track designation to PLX-200 for the treatment of patients with juvenile neuronal ceroid lipofuscinosis
20 August 2020 - Polaryx Therapeutics announced today that the U.S. FDA has granted fast track designation to PLX-200 for ...
Posted by Michael Wonder on 20 Aug 2020
Precision BioSciences receives fast track disease designation from U.S. FDA for PBCAR0191 investigational allogeneic CAR T-cell therapy
19 August 2020 - Precision BioSciences today announced the U.S. FDA has granted fast track designation to Precision for PBCAR0191, the ...