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RSS FeedPosted by Michael Wonder on 25 Aug 2020
F.D.A. ‘grossly misrepresented’ blood plasma data, scientists say
24 August 2020 - Many experts — including a scientist who worked on the Mayo Clinic study — were bewildered about ...
Posted by Michael Wonder on 25 Aug 2020
AbbVie aubmits regulatory application to FDA for Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
25 August 2020 - In a pivotal Phase 2/3 study, twice as many patients receiving Rinvoq achieved the primary endpoint of ...
Posted by Michael Wonder on 25 Aug 2020
As COVID-19 pressures mount, political newcomer Stephen Hahn struggles to protect an FDA under siege
24 August 2020 - Stephen Hahn, a political novice who moved here in December to take over the FDA, has ...
Posted by Michael Wonder on 25 Aug 2020
Turning Point Therapeutics granted fast-track designation for repotrectinib in NTRK positive TKI pre-treated advanced solid tumours
24 August 2020 - Turning Point Therapeutics today announced the FDA granted a third fast-track designation to its lead drug ...
Posted 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 ...