Blog
RSS FeedPosted by Michael Wonder on 28 Oct 2022
US FDA defers action on filing for AT-GAA in late-onset Pompe disease
28 October 2022 - FDA issues deferred action letter on AT-GAA regulatory filing due to the inability to conduct required manufacturing ...
Posted by Michael Wonder on 26 Oct 2022
US FDA delays panel meet on Perrigo's OTC birth control pill
26 October 2022 - The US FDA has delayed a meeting of its advisory panel to discuss Perrigo's over the ...
Posted by Michael Wonder on 25 Oct 2022
IntelGenx receives FDA GDUFA date for Xiromed partnered development candidate, buprenorphine buccal film
25 October 2022 - IntelGenx today announced that its previously undisclosed development candidate, buprenorphine buccal film, for which an abbreviated ...
Posted by Michael Wonder on 25 Oct 2022
Hugel Aesthetics receives FDA acceptance of BLA resubmission for letibotulinumtoxinA for injection for glabellar lines
25 October 2022 - PDUFA goal date set for 6 April 2023. ...
Posted by Michael Wonder on 17 Oct 2022
Biogen announces FDA’s 3 month extension of review period for the new drug application for tofersen
17 October 2022 - The new Prescription Drug User Fee Act action date set by the FDA is 25 April ...
Posted by Michael Wonder on 12 Oct 2022
Cystic fibrosis: Rotorua mother gives PHARMAC a year to fund Trikafta before moving overseas
13 October 2022 - A desperate Rotorua mother has been told by her doctor to consider getting a lung transplant ...
Posted by Michael Wonder on 10 Oct 2022
Monkeypox vaccine not expected in NZ until December as community spread confirmed
10 October 2022 - New Zealand now has community transmission of monkeypox, but a vaccine to protect those at highest ...
Posted by Michael Wonder on 04 Oct 2022
Split Real Time Application Review (STAR)
3 October 2022 - Under the Prescription Drug User Fee Act (PDUFA) VII Commitment Letter, the FDA is creating the Split ...
Posted by Michael Wonder on 14 Sep 2022
Has there actually been early resolution for early resolution resubmissions?
15 September 2022 - Following on from this week's article on early re-entry resubmissions, today we took a close look ...
Posted by Michael Wonder on 06 Sep 2022
Sanofi sees EU regulatory decision on its COVID booster in weeks
5 September 2022 - The European Union's drugs regulator may be a few weeks from deciding whether to approve the ...
Posted by Michael Wonder on 22 Aug 2022
Monkeypox vaccines not expected until December
20 August 2022 - Monkeypox vaccines aren't expected to arrive in New Zealand until December, according to PHARMAC. ...
Posted by Michael Wonder on 12 Aug 2022
Dismay as UK ‘drags its heels’ on AZ’s COVID antibody Evusheld
12 August 2022 - Half a million people in the UK with conditions like blood cancer that prevents them being ...
Posted by Michael Wonder on 10 Aug 2022
Few U.S. patients with hepatitis C get timely treatment, CDC says
9 August 2022 - Few U.S. adults diagnosed with hepatitis C virus infection receive timely treatment with anti-viral drugs, the ...
Posted by Michael Wonder on 09 Aug 2022
Reata Pharmaceuticals announces three month extension of the review period for new drug application for omaveloxolone for the treatment of Friedreich’s ataxia
9 August 2022 - PDUFA date extended to 28 February 2023. ...
Posted by Michael Wonder on 02 Aug 2022
Delay of Evrysdi reimbursement review denies SMA patients' right to drug choice
2 August 2022 - The Government has been dragging its feet to review insurance benefits for Roche's new spinal muscular ...