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RSS FeedPosted by Michael Wonder on 16 Jun 2021
Braeburn resubmits new drug application for Brixadi (buprenorphine) extended release subcutaneous injection for moderate to severe opioid use disorder
15 June 2021 - Braeburn announces that today the new drug application for Brixadi (buprenorphine) extended release injection for subcutaneous ...
Posted by Michael Wonder on 15 Jun 2021
Hugel America announces U.S. FDA acceptance of biologics license application for letibotulinumtoxinA for injection to treat glabellar (frown) lines
15 June 2021 - Prescription Drug User Fee Act target action date of 31 March 2022. ...
Posted by Michael Wonder on 14 Jun 2021
Ascendis Pharma announces extension of U.S. FDA review period for TransCon hGH (onapegsomatropin) for paediatric growth hormone deficiency
11 June 2021 - Prescription Drug User Fee Act goal date extended by three months for further review of submission to ...
Posted by Michael Wonder on 11 Jun 2021
Incyte announces U.S. FDA has extended the new drug application review period for ruxolitinib cream for the treatment of atopic dermatitis
11 June 2021 - Incyte announced today that the U.S. FDA has extended the review period for the new drug ...
Posted by Michael Wonder on 10 Jun 2021
FDA accepts filing of abbreviated new drug application and grants priority review for nalmefene hydrochloride injection for the treatment of known or suspected opioid overdose
10 June 2021 - Purdue Pharma announced that FDA has accepted and granted priority review to the company’s abbreviated new ...
Posted by Michael Wonder on 10 Jun 2021
Adamis provides update on Zimhi
9 June 2021 - FDA deems new drug application for Zimhi complete and establishes a target action date of 12 November ...
Posted by Michael Wonder on 08 Jun 2021
Incyte announces U.S. FDA has extended the sNDA review period for ruxolitinib (Jakafi) in chronic graft versus host disease
8 June 2021 - Incyte today announced that the U.S. FDA has extended the review period for the supplemental new drug ...
Posted by Michael Wonder on 03 Jun 2021
U.S. FDA accepts PharmaEssentia’s BLA resubmission for ropeginterferon alfa-2b-njft for the treatment of polycythemia vera
3 June 2021 - FDA assigns a new PDUFA action date of 13 November 2021. ...
Posted by Michael Wonder on 03 Jun 2021
Dermavant submits new drug application to FDA for tapinarof cream for the treatment of adults with plaque psoriasis
3 June 2021 - New drug application is supported by positive data from the Phase 3 PSOARING 1 and PSOARING 2 ...
Posted by Michael Wonder on 02 Jun 2021
Lupin announces U.S. FDA acceptance for pegfilgrastim biosimilar application
2 June 2021 - Lupin today announced that the U.S. FDA has accepted the biologics license application for its proposed ...
Posted by Michael Wonder on 02 Jun 2021
Bausch Health and Clearside Biomedical announce U.S. FDA filing acceptance for Xipere (triamcinolone acetonide suprachoroidal injectable suspension)
2 June 2021 - PDUFA action date Is 30 October 2021. ...
Posted by Michael Wonder on 02 Jun 2021
Amryt announces FDA acceptance of new drug application for Oleogel-S10 for the treatment of epidermolysis bullosa
2 June 2021 - Amryt today announces that the U.S. FDA has accepted for filing Amryt’s new drug application for Oleogel-S10 ...
Posted by Michael Wonder on 02 Jun 2021
Liquidia announces FDA acceptance of new drug application resubmission for LIQ861 (treprostinil) inhalation powder
2 June 2021 - Liquidia announced today that the U.S. FDA has accepted its new drug application resubmission for LIQ861 (treprostinil) ...
Posted by Michael Wonder on 01 Jun 2021
Novo Nordisk resubmits once weekly semaglutide 2 mg for the treatment of type 2 diabetes for US regulatory approval
29 May 2021 - Novo Nordisk today announced the resubmission of a label expansion application to the US FDA for the ...
Posted by Michael Wonder on 01 Jun 2021
CTI BioPharma announces acceptance of NDA granted with priority review of pacritinib for treatment of patients with myelofibrosis
1 June 2021 - PDUFA action date 30 November 2021. ...