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RSS FeedPosted by Michael Wonder on 10 Feb 2021
Botox (onabotulinumtoxinA) receives FDA approval for paediatric detrusor overactivity associated with a neurologic condition
10 February 2021 - Milestone marks 12th U.S. therapeutic indication for Botox. ...
Posted by Michael Wonder on 10 Feb 2021
Clarification on Sputnik V vaccine in the EU approval process
10 February 2021 - The EMA has to date not received an application for a rolling review or a marketing ...
Posted by Michael Wonder on 10 Feb 2021
EMA preparing guidance to tackle COVID-19 variants
10 February 2021 - EMA is developing guidance for manufacturers planning changes to the existing COVID-19 vaccines to tackle the new ...
Posted by Michael Wonder on 10 Feb 2021
FDA authorises monoclonal antibodies for treatment of COVID-19
9 February 2021 - Today, the U.S. FDA issued an emergency use authorisation for bamlanivimab and etesevimab administered together for the ...
Posted by Michael Wonder on 09 Feb 2021
FDA approves Libtayo (cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma
9 February 2021 - Libtayo now approved for patients with advanced stages of the two most common skin cancers in the ...
Posted by Michael Wonder on 09 Feb 2021
Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
8 February 2021 - As the Food and Drug Administration moves closer to a decision about whether to approve a ...
Posted by Michael Wonder on 09 Feb 2021
Supernus resubmits new drug application for SPN-812 for the treatment of ADHD in paediatric patients
8 February 2021 - Supernus Pharmaceuticals today announced it has resubmitted its ew drug application for SPN-812 for the treatment of ...
Posted by Michael Wonder on 09 Feb 2021
Woodcock vs. Sharfstein: a head to head comparison of Biden’s top choices for FDA commissioner
9 February 2021 - President Biden will soon have to nominate someone to helm the FDA. ...
Posted by Michael Wonder on 09 Feb 2021
Spravato (esketamine nasal spray) authorised in Europe for the rapid reduction of depressive symptoms in a psychiatric emergency for patients with major depressive disorder
8 February 2021 - This milestone makes esketamine nasal spray the first N-methyl-D-aspartate antagonist to be approved for patients with major ...
Posted by Michael Wonder on 09 Feb 2021
Bristol Myers Squibb receives European Commission approval for Inrebic (fedratinib) for adult patients with newly diagnosed and previously treated myelofibrosis
8 February 2021 - Inrebic, a once-daily, oral therapy, is the first new treatment option approved in Europe for myelofibrosis in ...
Posted by Michael Wonder on 09 Feb 2021
U.S. FDA grants breakthrough device designation to Vascular Perfusion Solutions for its visionary VP.S Encore cardiac transport device
8 February 2021 - The U.S. Food and Drug Administration (FDA) has granted Vascular Perfusion Solutions, Inc. (VPS) a Breakthrough Device ...
Posted by Michael Wonder on 09 Feb 2021
ViiV Healthcare receives marketing authorisation for Rukobia (fostemsavir), a first-in-class attachment inhibitor in combination with other antiretrovirals for the treatment of adults with multidrug-resistant HIV
8 February 2021 - Fostemsavir addresses a critical need in HIV care for those with little to no treatment options left ...
Posted by Michael Wonder on 09 Feb 2021
Pfizer vaccine bound for Australia won’t be blocked
9 February 2021 - Europe will not delay the first doses of Pfizer vaccine bound for Australia despite moves to block ...
Posted by Michael Wonder on 09 Feb 2021
Novartis receives FDA breakthrough therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukaemia
8 February 2021 - Designation in patients with chronic myeloid leukaemia (CML) resistant or intolerant to prior treatments based on positive ...
Posted by Michael Wonder on 09 Feb 2021
ShiraTronics receives FDA breakthrough device designation for chronic migraine neurostimulation
8 February 2021 - ShiraTronics announced today that it has been granted a breakthrough device designation by the Center of Devices ...