Blog
RSS FeedPosted by Michael Wonder on 13 Oct 2025
Denali Therapeutics announces FDA review extension of BLA for tividenofusp alfa for the treatment of MPS II (Hunter syndrome)
13 October 2025 - Denali Therapeutics today announced that the US FDA has extended its review timeline of the biologics license ...
Posted by Michael Wonder on 11 Oct 2025
MHRA and NICE invite early adopters to trial accelerated aligned pathway – six months ahead of schedule
10 October 2025 - Aligned pathway will streamline decisions on licensing and value for medicines, helping patients to benefit from them ...
Posted by Michael Wonder on 08 Oct 2025
Ontario connecting patients to life-saving cancer drugs faster
7 October 2025 - The Ontario Government is leading the world in cancer care by launching the Funding Accelerated for ...
Posted by Michael Wonder on 23 Sep 2025
Lexicon Pharmaceuticals announces update on submission of additional data to US FDA supporting the benefit-risk profile of Zynquista in type 1 diabetes
23 September 2025 - Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December ...
Posted by Michael Wonder on 22 Sep 2025
Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis
22 September 2025 - The US FDA has extended by three months the target action date of its review of the ...
Posted by Michael Wonder on 05 Sep 2025
Agios provides update on US PDUFA goal date for Pyrukynd (mitapivat) in thalassemia
4 September 2025 - Agios Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date for the supplemental ...
Posted by Michael Wonder on 21 Aug 2025
Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first
20 August 2025 - According to a recent analysis, Japanese regulators have the shortest time to approval for new drugs compared ...
Posted by Michael Wonder on 18 Aug 2025
RegenxBio announces FDA review extension of BLA for RGX-121 to treat patients with MPS II
18 August 2025 - RegenxBio today announced that the US FDA extended its review timeline of the biologics license application ...
Posted by Michael Wonder on 09 Aug 2025
International study on authorisation times confirms Swissmedic's competitiveness
6 August 2025 - Latest CIRS study rates Swissmedic's authorisation procedures for human medicinal products with new active substances as internationally ...
Posted by Michael Wonder on 08 Aug 2025
PBS wait times a more urgent issue than Donald Trump's potential pharmaceutical tariffs, peak medicines body warns
7 August 2025 - Excessive wait times for medicines to be listed on the PBS are a much greater threat ...
Posted by Michael Wonder on 06 Aug 2025
Patients to receive medicines 3 to 6 months faster under 10 year health plan
6 August 2025 - NICE and the MHRA have described how the 10 year health plan will lead to faster medicines ...
Posted by Michael Wonder on 01 Aug 2025
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel (tab-cel) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
24 July 2025 - PDUFA target action date of 10 January 2026. ...
Posted by Michael Wonder on 26 Jul 2025
Bayer provides regulatory update on elinzanetant in the US
25 July 2025 - Bayer today announced that the US FDA has notified the company that it has extended the ...
Posted by Michael Wonder on 24 Jul 2025
Commissioner's National Priority Voucher Pilot Program
22 July 2025 - Accelerated drug review for companies supporting US national interests. ...
Posted by Michael Wonder on 23 Jul 2025
GSK announces extension of US FDA an review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma
23 July 2025 - New PDUFA date scheduled for 23 October 2025. ...