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RSS FeedPosted 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
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
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 ...
Posted by Michael Wonder on 08 Feb 2021
Ellodi Pharmaceuticals announces fast track designation granted by the FDA to APT-1011 for the treatment of eosinophilic osophagitis
8 February 2021 - Ellodi Pharmaceuticals today announced that APT-1011 (fluticasone propionate oral disintegrating tablet) has been granted fast track designation ...
Posted by Michael Wonder on 08 Feb 2021
FDA grants breakthrough device designation for Roche's Elecsys growth differentiation factor-15 assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients
8 February 2021 - FDA BDD acknowledges the importance of GDF-15 testing in identifying eligible cachexic patients with solid tumours to ...
Posted by Michael Wonder on 08 Feb 2021
Puzzle Medical Devices receives U.S. FDA breakthrough device designation for its revolutionary minimally invasive transcatheter heart pump
8 February 2021 - Puzzle Medical Devices announced today that the U.S. FDA has granted the company a breakthrough revice designation ...
Posted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 06 Feb 2021
FDA blasts Keytruda data for new breast cancer indication as ‘questionable, immature, and unreliable’
5 February 2021 - Merck may have readily turned its Keytruda cancer drug into a medical and financial juggernaut, but ...
Posted by Michael Wonder on 06 Feb 2021
FDA authorises marketing of novel device to reduce snoring and mild obstructive sleep apnea in patients 18 years and older
5 February 2021 - Today, the U.S. FDA authorised marketing of a new prescription only device intended to reduce snoring and ...
Posted by Michael Wonder on 06 Feb 2021
FDA announces Advisory Committee meeting to discuss Janssen Biotech’s COVID-19 vaccine candidate
4 February 2021 - The U.S. FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee on ...
Posted by Michael Wonder on 06 Feb 2021
Johnson & Johnson announces submission of application to the U.S. FDA for Emergency Use Authorisation of its investigational single shot Janssen COVID-19 vaccine candidate
4 February 2021 - Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorisation, and expects to ...
Posted by Michael Wonder on 06 Feb 2021
FDA approves lisocabtagene maraleucel for relapsed or refractory large B-cell lymphoma
5 February 2021 - Today, the FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics) for the treatment of adult patients with ...
Posted by Michael Wonder on 06 Feb 2021
FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma
5 February 2021 - Today, the Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase ...