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RSS FeedPosted by Michael Wonder on 08 Mar 2019
FDA accepts supplemental biologics license applications for Botox (onabotulinumtoxinA) for paediatric patients with upper and lower limb spasticity
7 March 2019 - Applications seek to extend use of Botox for patients 2 to 17 years old. ...
Posted by Michael Wonder on 07 Mar 2019
Genentech submits supplemental new drug application to FDA for Venclexta plus Gazyva for previously untreated chronic lymphocytic leukaemia with co-existing medical conditions
7 March 2019 - Combination was granted breakthrough therapy designation, the fifth for Venclexta. ...
Posted by Michael Wonder on 07 Mar 2019
FDA accepts Genentech’s supplemental new drug application for Xofluza (baloxavir marboxil) for the treatment of influenza in people at high risk of complications
5 March 2019 - Xofluza would be the first antiviral medicine approved specifically for the high-risk population. ...
Posted by Michael Wonder on 05 Mar 2019
FDA grants rolling review for CytoDyn’s planned BLA for investigational HIV therapy leronlimab (PRO 140)
4 March 2019 - CytoDyn today announced that the FDA has reviewed and accepted CytoDyn’s request and plan to submit on ...
Posted by Michael Wonder on 04 Mar 2019
Intellipharmaceutics announces resubmission of new drug application to the U.S. FDA for its oxycodone ER
4 March 2019 - Intellipharmaceutics today announced that it has resubmitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 04 Mar 2019
Novo Nordisk files for a label update for Fiasp to the EMA and the FDA seeking approval for use in children and adolescents
1 March 2019 - Novo Nordisk today announced that it has submitted label updates to the EMA and the US FDA ...
Posted by Michael Wonder on 01 Mar 2019
Esperion announces submissions of two NDAs and official completion of two MAA validations for both bempedoic acid and the bempedoic acid/ezetimibe combination tablet
28 February 2019 - Esperion today announced that the company has successfully completed important and key global marketing applications including ...
Posted by Michael Wonder on 26 Feb 2019
A small drug maker settles charges for paying others to submit its FDA applications
26 February 2019 - A small drug maker was fined $4 million for striking deals with two tiny companies to ...
Posted by Michael Wonder on 25 Feb 2019
Alkermes and Biogen announce U.S. FDA acceptance of diroximel fumarate new drug application for multiple sclerosis
25 February 2019 - Alkermes and Biogen today announced that the U.S. FDA has accepted for review the new drug ...
Posted by Michael Wonder on 23 Feb 2019
Alder BioPharmaceuticals submits biologics license application to the U.S. FDA for eptinezumab
22 February 2019 - Significant milestone toward the commercialisation of eptinezumab, the first quarterly infusion therapy for migraine prevention. ...
Posted by Michael Wonder on 23 Feb 2019
FDA grants priority review and accepts sBLA of Soliris (eculizumab) as a treatment for patients with neuromyelitis optica spectrum disorder
22 February 2019 - FDA sets action date of 28 June 2019. ...
Posted by Michael Wonder on 21 Feb 2019
Nabriva Therapeutics announces acceptance of new drug applications by the FDA for intravenous and oral lefamulin to treat community-acquired bacterial pneumonia in adults
19 February 2019 - PDUFA action date set for August 19, 2019. ...
Posted by Michael Wonder on 20 Feb 2019
Agios announces FDA acceptance of supplemental new drug application for Tibsovo (ivosidenib) for the treatment of patients with newly diagnosed acute myeloid leukaemia with an IDH1 mutation not eligible for standard therapy
20 February 2019 - PDUFA date set for June 21 2019. ...
Posted by Michael Wonder on 20 Feb 2019
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) monotherapy for third-line treatment of patients with advanced small cell lung cancer
20 February 2019 - Marks first application for Keytruda in SCLC. ...
Posted by Michael Wonder on 19 Feb 2019
Pfenex announces FDA acceptance of NDA for PF708
19 February 2019 - FDA sets PDUFA date of 7 October 2019. ...