Blog
RSS FeedPosted 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 18 Jun 2021
3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...
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
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 28 May 2021
Verrica Pharmaceuticals announces extension of FDA review period of its NDA for VP-102 for the treatment of molluscum contagiosum
28 May 2021 - Prescription Drug User Fee Act goal date extended by three months to 23 September 2021. ...
Posted by Michael Wonder on 20 May 2021
Omeros announces extension of FDA review period for narsoplimab in HSCT-TMA
20 May 2021 - PDUFA date is 17 October 2021. ...
Posted by Michael Wonder on 14 Apr 2021
New blow to rollout as Novavax Covid-19 vaccine hits supply hiccup
15 April 2021 - Australia’s vaccine rollout has been dealt another blow as Novavax confirms manufacturing supply shortages mean it ...
Posted by Michael Wonder on 13 Apr 2021
Adamis Pharmaceuticals provides an update on Zimhi
12 April 2021 - Adamis Pharmaceuticals today provided an update on the status of the company’s new drug application relating ...
Posted by Michael Wonder on 09 Apr 2021
Provention Bio provides regulatory update on biologics license application for teplizumab for the delay or prevention of clinical type 1 diabetes in at risk individuals
8 April 2021 - Provention Bio today announced that the company received a notification on 2 April 2021 from the U.S. ...
Posted by Michael Wonder on 08 Apr 2021
‘Before end of this year’: Novavax COVID vaccine could be months away
8 April 2021 - Regulatory approvals for the third pillar of Australia’s vaccine strategy may not be obtained until the ...
Posted by Michael Wonder on 07 Apr 2021
Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis
7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new ...