Blog
RSS FeedPosted by Michael Wonder on 31 Aug 2025
FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease
29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...
Posted by Michael Wonder on 02 Apr 2026
Fore Biotherapeutics receives breakthrough therapy designation for plixorafenib
1 April 2026 - Fore Biotherapeutics today announced that the US FDA has granted breakthrough therapy designation to plixorafenib for the ...
Posted by Michael Wonder on 02 Apr 2026
Trump puts Australia’s drugs scheme, digital rules in firing line
1 April 2026 - Donald Trump’s top trade tsar claims Australia’s unfair drug pricing practices are undermining US innovation, warns ...
Posted by Michael Wonder on 02 Apr 2026
Pasithea Therapeutics announces grant of fast track designation by FDA to PAS-004 for treatment of neurofibromatosis type 1 associated plexiform neurofibromas causing significant morbidity
1 April 2026 - Pasithea Therapeutics today announced that the US FDA has granted fast track designation to PAS-004 for ...
Posted by Michael Wonder on 02 Apr 2026
A2 Biotherapeutics receives US FDA fast track designation for A2B543, a logic-gated CAR T-cell therapy enhanced with a membrane-tethered IL-12 booster
1 April 2026 - A2 Biotherapeutics today announced that the US FDA has granted fast track designation for A2B543, an autologous ...
Posted by Michael Wonder on 01 Apr 2026
FDA approves Lilly's Foundayo (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions
1 April 2026 - Foundayo, Lilly's second FDA approved obesity medicine, will be available via LillyDirect with free home delivery, ...
Posted by Michael Wonder on 01 Apr 2026
Oculis announces EMA PRIME designation for privosegtor, advancing a potential first in class neuroprotective candidate for optic neuritis
31 March 2026 - Decision supported by positive Phase 2 ACUITY data showing substantial improvements in vision combined with anatomical and ...
Posted by Michael Wonder on 01 Apr 2026
Vertex announces US FDA approval for label extensions of Alyftrek and Trikafta, expanding availability of these medicines to ~95% of all people with CF in the United States
1 April 2026 - Vertex Pharmaceuticals today announced the US FDA has approved expanded use of Alyftrek (vanzacaftor/tezacaftor/deutivacaftor) for the ...
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 01 Apr 2026
FDA approves first new molecular entity under National Priority Voucher Program
1 April 2026 - The US FDA today approved Foundayo (orforglipron), marking the fifth approval under the Commissioner's National Priority Voucher ...
Posted by Michael Wonder on 01 Apr 2026
Injection for more than a million people to help prevent heart attacks and strokes recommended
1 April 2026 - People who have had a heart attack, stroke, or serious circulation problem in their legs, and who ...
Posted by Michael Wonder on 01 Apr 2026
New Zealand Pharmaceutical Schedule - 1 April 2026
1 April 2026 - The April 2026 issue of the New Zealand Pharmaceutical Schedule is now available and in effect. ...
Posted by Michael Wonder on 01 Apr 2026
Scholar Rock resubmits biologics license application to FDA for apitegromab for treatment of children and adults with spinal muscular atrophy
31 March 2026 - Apitegromab biologics license application resubmission includes Catalent Indiana (part of Novo Nordisk) and second US based fill ...
Posted by Michael Wonder on 01 Apr 2026
Henlius receives two positive CHMP opinions for serplulimab, advancing global regulatory progress
30 March 2026 - Shanghai Henlius Biotech today announced that its self-developed anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly), ...
Posted by Michael Wonder on 01 Apr 2026
Cheaper medicines for people fighting cancer and rare diseases
1 April 2026 - The Albanese Government is continuing to deliver cheaper medicines with Australians living with debilitating conditions including ...
Posted by Michael Wonder on 31 Mar 2026
Schedule of Pharmaceutical Benefits - 1 April 2026
1 April 2026 - The April 2026 issue of the Schedule of Pharmaceutical Benefits is out and now in effect. ...