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RSS FeedPosted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 12 Oct 2021
GenSight Biologics announces FDA grant of fast track designation for optogenetic therapy GS030 as treatment for retinitis pigmentosa
12 October 2021 - GenSight Biologics today announced that the U.S. FDA has granted fast track designation to GS030, which combines ...
Posted by Michael Wonder on 12 Oct 2021
Quanterix granted breakthrough device designation from U.S. FDA for blood based pTau 181 assay for Alzheimer’s disease
11 October 2021 - Quanterix Corporation announced today that its Simoa phospho-Tau 181 (pTau-181) blood test has been granted breakthrough ...
Posted by Michael Wonder on 11 Oct 2021
Merck and Ridgeback announce submission of emergency use authorisation application to the U.S. FDA for molnupiravir, an investigational oral anti-viral medicine, for the treatment of mild to moderate COVID-19 in at risk adults
11 October 2021 - Submissions to regulatory agencies worldwide underway. ...
Posted by Michael Wonder on 11 Oct 2021
Ocular Therapeutix announces FDA approval of supplemental new drug application for Dextenza (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use for the treatment of ocular itching associated with allergic conjunctivitis
11 October 2021 - Approval represents the first primarily office-based indication for Dextenza. ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...
Posted by Michael Wonder on 10 Oct 2021
Brii Bio initiates submission of emergency use authorisation filing to U.S. FDA for BRII-196/BRII-198, its monoclonal antibody combination therapy for non-hospitalised COVID-19 patients at high risk of clinical progression to severe disease
8 October 2021 - Data supporting the EUA filing will be submitted to the FDA on a rolling basis with the ...
Posted by Michael Wonder on 10 Oct 2021
New FDA chief can't come soon enough for beleaguered agency
8 October 2021 - One of the leading agencies in the government’s fight against COVID-19 is finally on the verge of ...
Posted by Michael Wonder on 09 Oct 2021
Alpha Tau receives FDA's breakthrough device designation for the treatment of recurrent glioblastoma multiforme
8 October 2021 - Alpha Tau Medical is pleased to announce that it has received breakthrough device designation for Alpha ...
Posted by Michael Wonder on 09 Oct 2021
Egetis Therapeutics receives FDA fast track designation for Emcitate for MCT8 deficiency
8 October 2021 - Egetis Therapeutics today announced that the U.S. FDA has granted the company’s lead candidate drug Emcitate, currently ...
Posted by Michael Wonder on 09 Oct 2021
FDA approves innovative treatment for paediatric patients with congenital athymia
8 October 2021 - Today, the U.S. FDA approved Rethymic for the treatment of paediatric patients with congenital athymia, a rare ...
Posted by Michael Wonder on 08 Oct 2021
Janssen submits application seeking U.S. FDA approval of Stelara (ustekinumab) for the treatment of paediatric patients with juvenile psoriatic arthritis
8 October 2021 - Application utilises extrapolation-based strategy across existing breadth of Stelara data in patients living with this chronic inflammatory ...
Posted by Michael Wonder on 08 Oct 2021
Genentech’s anti-amyloid beta antibody gantenerumab granted FDA breakthrough therapy designation in Alzheimer’s disease
8 October 2021 - Gantenerumab is an investigational antibody in Phase 3 development for early Alzheimer's disease. ...
Posted by Michael Wonder on 08 Oct 2021
ChemoCentryx announces FDA approval of Tavneos (avacopan) in ANCA associated vasculitis
8 October 2021 - First FDA approved orally administered inhibitor of the complement 5a receptor. ...
Posted by Michael Wonder on 08 Oct 2021
Recursion is granted FDA fast track designation for REC-2282 for the potential treatment of NF2 mutated meningiomas
7 October 2021 - Recursion today announced that the U.S. FDA has granted the company fast track designation for the ...