Blog
RSS FeedPosted by Michael Wonder on 15 Jul 2025
New cystic fibrosis drug fast tracked for NHS use
15 July 2025 - Some people with cystic fibrosis are set to benefit from a new once daily triple therapy treatment, ...
Posted by Michael Wonder on 11 Jul 2025
Capricor Therapeutics provides regulatory update on deramiocel BLA for Duchenne muscular systrophy
11 July 2025 - Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial in ...
Posted by Michael Wonder on 10 Jul 2025
MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause
8 July 2025 - The MHRA has today become the first regulator in the world to approve elinzanetant (Lynkuet) for the ...
Posted by Michael Wonder on 10 Jul 2025
Albanese should consider tweaks to PBS to avoid Trump tariff: CSL chair
9 July 2025 - Donald Trump’s move to ramp up tariffs on medicines and copper has sparked alarm among government ...
Posted by Michael Wonder on 09 Jul 2025
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding ...
Posted by Michael Wonder on 09 Jul 2025
New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss
8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...
Posted by Michael Wonder on 09 Jul 2025
Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo
8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...
Posted by Michael Wonder on 09 Jul 2025
PBS ‘not on the table’ in battle for pharmaceutical tariff exemption, despite lobbying
9 July 2025 - The threat of global 200 per cent tariffs on pharmaceutical products presents a challenge to Australia’s drug ...
Posted by Michael Wonder on 08 Jul 2025
Drug reimbursement panel approves iptacopan for PNH reimbursement, rejects danicopan over cost concerns
7 March 2025 - The Pharmaceutical Reimbursement Review Committee has made mixed decisions on the two medicines for paroxysmal nocturnal ...
Posted by Michael Wonder on 08 Jul 2025
Lexeo Therapeutics announces FDA breakthrough therapy designation for LX2006 in Friedreich ataxia
7 July 2025 - Breakthrough therapy designation based on interim clinical data from Phase I/II trials showing clinically meaningful improvements in ...
Posted by Michael Wonder on 08 Jul 2025
Denali Therapeutics announces FDA acceptance and priority review of biologics license application for tividenofusp alfa for Hunter syndrome
7 July 2025 - FDA assigns PDUFA target action date of 5 January 2026, for decision on accelerated approval. ...
Posted by Michael Wonder on 07 Jul 2025
KalVista Pharmaceuticals announces FDA Approval of Ekterly (sebetralstat), first and only oral on-demand treatment for hereditary angioedema
7 July 2025 - First new on demand hereditary angioedema treatment in over a decade, with potential to transform management of the ...
Posted by Michael Wonder on 07 Jul 2025
Will miracle HIV drug go on the PBS?
5 July 2025 - A new twice yearly antiviral injection that can prevent HIV is likely to be approved soon in ...
Posted by Michael Wonder on 06 Jul 2025
Garadacimab for the prevention of recurrent attacks of hereditary angioedema in patients 12 years of age and older
2 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 06 Jul 2025
MHRA approves nogapendekin alfa inbakicept to treat adult patients with non-muscle invasive bladder cancer
4 July 2025 - The MHRA has today approved nogapendekin alfa inbakicept (Anktiva) for adults with BCG unresponsive non-muscle invasive bladder ...
Posted by Michael Wonder on 05 Jul 2025
Quebec implements public reimbursement of Pluvicto - a defining milestone for radioligand therapy in Canada
3 July 2025 - Pluvicto now publicly funded in provinces covering most Canadians, offering renewed hope to those facing progressive PSMA ...