Blog
RSS FeedPosted by Michael Wonder on 24 Jun 2021
FDA accepts application for Genentech’s port delivery system with ranibizumab for treatment of wet age related macular degeneration
24 June 2021 - If approved, PDS would be the first and only eye implant with continuous drug delivery that offers ...
Posted by Michael Wonder on 22 Jun 2021
Fennec Pharmaceuticals announces FDA acceptance of new drug application resubmission for Pedmark
22 June 2021 - Prescription Drug User Fee Act target action date set for 27 November 2021. ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
Agios submits new drug application to FDA for mitapivat for treatment of adults with pyruvate kinase deficiency
21 June 2021 - Agios Pharmaceuticals today announced that it has submitted a new drug application for mitapivat to the U.S. ...
Posted by Michael Wonder on 17 Jun 2021
Amneal announces U.S. FDA filing acceptance of biologics license application for bevacizumab
17 June 2021 - Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA. ...
Posted by Michael Wonder on 17 Jun 2021
Eagle Pharmaceuticals submits response to complete response letter from FDA for vasopressin
17 June 2021 - Eagle Pharmaceuticals today announced that it has responded to the complete response letter for its abbreviated ...
Posted 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 ...