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RSS FeedPosted by Michael Wonder on 17 Feb 2021
BeiGene announces U.S. FDA acceptance of supplemental new drug application for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
17 February 2021 - BeiGene today announced that the U.S. FDA has accepted a supplemental new drug application for Brukinsa (zanubrutinib) ...
Posted by Michael Wonder on 17 Feb 2021
FDA grants sotorasib priority review designation for the treatment of patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer
16 February 2021 - FDA target action date is 16 August 2021 ...
Posted by Michael Wonder on 16 Feb 2021
Jazz Pharmaceuticals completes submission of supplemental new drug application for Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for idiopathic hypersomnia
16 February 2021 - Jazz Pharmaceuticals today announced the completion of the rolling submission for the supplemental new drug application to ...
Posted by Michael Wonder on 16 Feb 2021
Sesen Bio announces FDA acceptance and priority review of its biologics license application for Vicineum
16 February 2021 - FDA stated it is not currently planning to hold an advisory committee meeting. ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
Posted by Michael Wonder on 11 Feb 2021
Seagen and Genmab submit tisotumab vedotin biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
11 February 2021 - Submission based on positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology ...
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 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
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 02 Feb 2021
VBI Vaccines announces U.S. FDA acceptance of BLA filing for VBI’s 3 antigen prophylactic hepatitis B vaccine
2 February 2021 - FDA sets a target action date of 30 November 2021. ...
Posted by Michael Wonder on 02 Feb 2021
Mirum Pharmaceuticals announces completion of rolling NDA submission for maralixibat in Alagille syndrome
1 February 2021 - Maralixibat U.S. launch expected in second half of 2021, if approved. ...
Posted by Michael Wonder on 02 Feb 2021
Bristol Myers Squibb application for Zeposia (ozanimod) for the treatment of ulcerative colitis accepted for filing with priority review by U.S. FDA
1 February 2021 - U.S. Food and Drug Administration assigned an action date of 30 May 2021. ...
Posted by Michael Wonder on 29 Jan 2021
Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab
29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June ...
Posted by Michael Wonder on 28 Jan 2021
Bio-Thera Solutions announces FDA accepts biologics license application for BAT1706, a proposed biosimilar to Avastin
28 January 2021 - Bio-Thera Solutions today announced that the U.S. FDA has accepted its biologics license application for BAT1706, a ...