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RSS FeedPosted 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 ...
Posted by Michael Wonder on 26 Jan 2021
Vertex announces U.S. FDA acceptance of supplemental new drug application for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 with certain mutations
26 January 2021 - FDA grants priority review of the application and sets a PDUFA target action date of 8 June ...
Posted by Michael Wonder on 26 Jan 2021
Albireo announces U.S. FDA acceptance of new drug application for odevixibat
25 January 2021 - FDA has granted odevixibat fast track, rare paediatric disease and orphan drug designations. ...
Posted by Michael Wonder on 26 Jan 2021
Iterum Therapeutics announces U.S. FDA filing acceptance of new drug application for oral sulopenem
25 January 2021 - If approved, first oral penem in the U.S. and first new oral treatment for uUTIs in over ...
Posted by Michael Wonder on 21 Jan 2021
FDA grants priority review to Genentech’s Esbriet (pirfenidone) for unclassifiable interstitial lung disease
21 January 2021 - Genentech announced today that the U.S. FDA has accepted the company’s supplemental new drug application and granted ...
Posted by Michael Wonder on 21 Jan 2021
Impel NeuroPharma announces U.S. FDA acceptance of new drug application for INP104 for the acute treatment of migraine
20 January 2021 - FDA conditionally accepts trade name, Trudhesa, pending approval of the new drug application, and sets PDUFA goal ...
Posted by Michael Wonder on 20 Jan 2021
U.S. FDA accepts for priority review application for Opdivo (nivolumab) combined with chemotherapy as first-line treatment in metastatic gastric cancer, gastro-oesophageal junction cancer and oesophageal adenocarcinoma
20 January 2021 - U.S. FDA assigned a target action date of 25 May 2021. ...
Posted by Michael Wonder on 20 Jan 2021
U.S. Food and Drug Administration accepts for priority review application for Opdivo (nivolumab) as adjuvant therapy for patients with resected oesophageal or gastro-oesophageal junction cancer
20 January 2021 - Application based on Phase 3 CheckMate-577 trial, in which Opdivo doubled median disease-free survival versus placebo in ...