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RSS FeedPosted by Michael Wonder on 09 Aug 2018
Glenmark Pharmaceuticals announces FDA acceptance of the company's first new drug application for Ryaltris for patients with seasonal allergic rhinitis
7 August 2018 - The PDUFA target action date for completion of the FDA review is 21 March 2019. ...
Posted by Michael Wonder on 09 Aug 2018
Genmab announces submission of U.S. & EU regulatory applications seeking approval of Darzalex (daratumumab) split dosing regimen
8 August 2018 - Applications seek to update prescribing information and summary of product characteristics. ...
Posted by Michael Wonder on 08 Aug 2018
The FDA is poised to approve the first-ever drug that mutes disease-causing genes
7 August 2018 - After a decades-long wait, the FDA is on the brink of approving a landmark rare disease ...
Posted by Michael Wonder on 06 Aug 2018
Karyopharm completes rolling submission of new drug application to U.S. FDA for selinexor as a treatment for patients with penta-refractory multiple myeloma
6 August 2018 - Selinexor has received both orphan drug and fast track designations from the FDA for this indication. ...
Posted by Michael Wonder on 02 Aug 2018
Evolus announces early resubmission to the FDA of its biologics licence application for DWP-450
2 August 2018 - Commercial launch planned for spring 2019. ...
Posted by Michael Wonder on 02 Aug 2018
Acrux submits first-to-file application for generic version of Jublia making it eligible for 180 days of generic exclusivity
2 August 2018 - Acrux is pleased to announce that the US FDA has accepted for review the Paragraph IV Abbreviated ...
Posted by Michael Wonder on 31 Jul 2018
Nektar Therapeutics announces new drug application for NKTR-181 accepted for review by FDA
30 July 2018 - NKTR-181 is a first-in-class investigational opioid to treat chronic low back pain in adult patients new to ...
Posted by Michael Wonder on 31 Jul 2018
FDA accepts file for cladribine tablets as potential treatment for relapsing forms of multiple sclerosis
30 July 2018 - Cladribine tablets is approved as Mavenclad in 38 countries. ...
Posted by Michael Wonder on 27 Jul 2018
ADMA Biologics receives PDUFA date for Bivigam regulatory submission
26 July 2018 - Prior approval supplement to amend the biologics license application for Bivigam is supported by data and documentation ...
Posted by Michael Wonder on 23 Jul 2018
Aerie Pharmaceuticals announces early notification of FDA acceptance of NDA submission for Roclatan (netarsudil/latanoprost ophthalmic solution)
23 July 2018 - Aerie Pharmaceuticals today reported that it has received the “Day 74” notification from the U.S. FDA earlier ...
Posted by Michael Wonder on 19 Jul 2018
Ocular Therapeutix announces FDA acceptance of NDA resubmission for Dextenza
19 July 2018 - PDUFA date is set for 28 December 2018. ...
Posted by Michael Wonder on 16 Jul 2018
U.S. FDA extends review timeline for Invokana (canagliflozin) supplemental new drug application
13 July 2018 - The application seeks a new indication for Invokana to reduce the risk of major adverse cardiovascular ...
Posted by Michael Wonder on 13 Jul 2018
Amgen and UCB resubmit biologics license application for Evenity (romosozumab) to the US FDA
12 July 2018 - Application includes data from pivotal Phase 3 studies of more than 11,000 patients. ...
Posted by Michael Wonder on 12 Jul 2018
AbbVie announces submission of supplemental new drug application to US FDA for venetoclax in newly diagnosed acute myeloid leukaemia patients ineligible for intensive chemotherapy
12 July 2018 - The US FDA has granted venetoclax two breakthrough therapy designations in acute myeloid leukaemia, which are ...
Posted by Michael Wonder on 11 Jul 2018
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) for the treatment of patients with advanced hepatocellular carcinoma
11 July 2018 - Application based on monotherapy data from phase 2 KEYNOTE-224 trial. ...