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RSS FeedPosted by Michael Wonder on 28 May 2026
Beren Therapeutics announces FDA extension of review period for new drug application for adrabetadex for the treatment of infantile-onset Niemann-Pick disease, type C
28 May 2026 - Beren Therapeutics announced that the US FDA has extended by three months the review timeline of its ...
Posted by Michael Wonder on 27 May 2026
US FDA decision date extended for SERENA-6 filing of camizestrant to enable review of additional data
27 May 2026 - The US FDA has informed AstraZeneca that it will extend the PDUFA date to review additional data ...
Posted by Michael Wonder on 17 May 2026
New medicines may be out of reach of PBS patients as Australia fails to adapt to ‘seismic market shifts’
18 May 2026 - Donald Trump’s medicines prices policy is causing global market disruption even as Australia’s broken approval processes leave ...
Posted by Michael Wonder on 08 May 2026
Update on FDA priority review of Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease
8 May 2026 - Eisai and Biogen today announced that the US FDA has extended the review period by three months ...
Posted by Michael Wonder on 30 Apr 2026
MHRA delivers its targets to increase access to medicines and reinforce UK position as a global destination for life sciences
28 April 2026 - The MHRA continues to speed up access to medicines for patients, increase efficiency of regulation and help ...
Posted by Michael Wonder on 29 Apr 2026
FDA announces major steps to implement real time clinical trials
28 April 2026 - The US FDA today announced two major steps as part of an initiative to advance the implementation ...
Posted by Michael Wonder on 22 Apr 2026
Sanofi provides update on the regulatory submission for Sarclisa subcutaneous in the US
22 April 2026 - The US FDA has extended by up to three months the target action date for its review ...
Posted by Michael Wonder on 21 Apr 2026
PBS reform critical to accessing medical breakthroughs
20 April 2026 - We are witnessing an extraordinary medical revolution. Advances that once belonged in science fiction, like regenerative ...
Posted by Michael Wonder on 16 Apr 2026
Savara announces the US FDA has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis
15 April 2026 - Savara today announced that the FDA has extended the review period for the molgramostim BLA in ...
Posted by Michael Wonder on 15 Apr 2026
Praxis Precision Medicines announces FDA acceptance of new drug application for ulixacaltamide hydrochloride in patients with essential tremor
14 April 2026 - - Praxis Precision Medicines today announced that the US FDA has accepted for review its new drug ...
Posted by Michael Wonder on 03 Apr 2026
MHRA-NICE pathway opens for business – everything you need to know to get started
1 April 2026 - Today marks a significant milestone for patients, the NHS and the pharmaceutical industry. From 1 April 2026, ...
Posted by Michael Wonder on 01 Apr 2026
Orca Bio announces FDA review extension of BLA for Orca-T for the treatment of haematologic malignancies
1 April 2026 - Orca Bio today announced that the US FDA has extended the review timeline of its biologics license ...
Posted by Michael Wonder on 18 Mar 2026
Patients to get new medicines up to six months sooner
17 March 2026 - Patients in England are set to receive some new medicines 3 to 6 months earlier under a ...
Posted by Michael Wonder on 05 Mar 2026
PDUFA action date for Hansa Biopharma's imlifidase BLA set for 19 December 2026
4 March 2026 - If approved, imlifidase will be the first treatment to address highly sensitised patients awaiting kidney transplantation. ...
Posted by Michael Wonder on 12 Feb 2026
Sick Australians risk being locked out of lifesaving medicines by outdated PBS
12 February 2026 - More medicines are successfully treating illness and disease, but Pfizer’s local boss says the PBS is falling ...