Blog
RSS FeedPosted by Michael Wonder on 19 Jul 2021
AbbVie provides update regarding Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis in the U.S.
16 July 2021 - AbbVie today announced the U.S. FDA did not meet the Prescription Drug User Fee Act action ...
Posted by Michael Wonder on 18 Jul 2021
U.S. FDA grants priority review for the biologics license application for Pfizer-BioNTech COVID-19 vaccine
16 July 2021 - Pfizer and BioNTech today announced that the U.S. FDA granted priority review designation for the biologics license ...
Posted by Michael Wonder on 09 Jul 2021
Pfizer plans to request FDA approval for COVID booster shot in August
9 Jul 2021 - Pfizer plans to request US emergency authorisation in August for a third booster dose of its ...
Posted by Michael Wonder on 08 Jul 2021
Tezepelumab regulatory submission accepted and granted FDA priority review in the US for the treatment of patients with asthma
8 July 2021 - Tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a ...
Posted by Michael Wonder on 07 Jul 2021
ChemoCentryx announces filing of amendment to NDA submission and extension of the PDUFA review period for avacopan in the treatment of ANCA associated vasculitis
6 July 2021 - ChemoCentryx today announced that, following consultations with the U.S. FDA, it filed an amendment to its new ...
Posted by Michael Wonder on 06 Jul 2021
ANI Pharmaceuticals announces refiling of Cortrophin sNDA with FDA
6 July 2021 - ANI Pharmaceuticals today announced that the Company has re-filed its supplemental new drug application for Cortrophin Gel ...
Posted by Michael Wonder on 06 Jul 2021
Athenex provides update from FDA Type A meeting regarding oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
6 July 2021 - Athenex today announced that the Company held a Type A meeting with the U.S. FDA during the ...
Posted by Michael Wonder on 03 Jul 2021
Iterum Therapeutics provides regulatory update
1 July 2021 - Iterum Therapeutics today announced that the Company received a letter from the U.S.FDA stating that, as ...
Posted by Michael Wonder on 01 Jul 2021
U.S. FDA accepts filing of Hutchmed's NDA for surufatinib for the treatment of advanced neuroendocrine tumours
1 July 2021 - U.S. FDA has assigned a target action date of 30 April 2022. ...
Posted by Michael Wonder on 29 Jun 2021
Gilead submits new drug application to U.S. FDA for lenacapavir, an investigational, long-acting capsid inhibitor for the treatment of HIV-1 in people with limited therapy options
28 June 2021 - If approved, lenacapavir would be the first capsid inhibitor and the only HIV-1 treatment option administered ...
Posted by Michael Wonder on 28 Jun 2021
Eagle Pharmaceuticals announces FDA maintains prioritisation of ANDA for vasopressin
24 June 2021 - Assigned GDUFA date of 15 December 2021, and expects commercial launch prior to year-end. ...
Posted by Michael Wonder on 27 Jun 2021
Camurus announces PDUFA date for Brixadi for the treatment of opioid use disorder in the US
26 June 2021 - New PDUFA action date for Brixadi set for 15 December 2021. ...
Posted by Michael Wonder on 26 Jun 2021
AbbVie provides update regarding Rinvoq (upadacitinib) in psoriatic arthritis and ankylosing spondylitis in the U.S.
25 June 2021 - AbbVie today announced that the U.S. FDA has informed the company that the FDA will not ...
Posted by Michael Wonder on 25 Jun 2021
Aquestive Therapeutics resubmits new drug application for Libervant (diazepam) buccal film
24 June 2021 - Anticipates FDA PDUFA goal date in late 2021. ...
Posted by Michael Wonder on 24 Jun 2021
Alnylam announces U.S. FDA acceptance of new drug application for investigational vutrisiran for the treatment of the polyneuropathy of hereditary ATTR amyloidosis
24 June 2021 - PDUFA date set for 14 April 2022. ...