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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 13 Mar 2026
MHRA approves deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults
12 March 2026 - The MHRA has approved deuruxolitinib (Leqselvi) to treat severe alopecia areata in adults. ...
Posted by Michael Wonder on 12 Mar 2026
ICER releases draft evidence report on treatment for narcolepsy
12 March 2026 - Public comment period now open until 7 April 2026; requests to make oral comment during public ...
Posted by Michael Wonder on 12 Mar 2026
500,000 eligible to benefit from new non-hormonal treatment for hot flushes caused by menopause
11 March 2026 - A new treatment option for menopausal hot flushes and night sweats can be used in the NHS ...
Posted by Michael Wonder on 12 Mar 2026
ARTHEx Biotech granted FDA fast track designation for ATX-01 for the treatment of myotonic dystrophy type 1
11 March 2026 - ARTHEx Biotech today announced that the US FDA has granted fast track designation to ATX-01 for the ...
Posted by Michael Wonder on 12 Mar 2026
Health ministry cautious on timing of generic drug price cuts, reaffirms ‘no-exception’ principle
11 March 2026 - Amid mounting opposition from the pharmaceutical industry over the government's proposed “drug pricing system improvement plan,” ...
Posted by Michael Wonder on 12 Mar 2026
Quoin Pharmaceuticals announces FDA grants fast track designation for QRX003 for the treatment of Netherton syndrome
11 March 2026 - Quoin Pharmaceuticals today announced that the US FDA has granted fast track designation to QRX003 lotion (4%) ...
Posted by Michael Wonder on 11 Mar 2026
Capricor Therapeutics announces establishment of new PDUFA date for deramiocel BLA
10 March 2026 - Capricor Therapeutics today announced that the US FDA has lifted the previously issued complete response letter ...
Posted by Michael Wonder on 11 Mar 2026
PHARMAC to fund life‑changing treatments for children with cystic fibrosis
11 March 2026 - PHARMAC will fund new treatment options for people living with cystic fibrosis from 1 April 2026. ...
Posted by Michael Wonder on 11 Mar 2026
Tecvayli (teclistamab) monotherapy application submitted to the EMA for relapsed/refractory multiple myeloma after at least one prior therapy
10 March 2026 - Johnson & Johnson today announced the submission of a type II variation application to the EMA seeking ...
Posted by Michael Wonder on 11 Mar 2026
Lenz Therapeutics announces submission of marketing authorisation application to the EMA for Vizz for the treatment of presbyopia
10 March 2026 - Lenz Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 10 Mar 2026
Cutting-edge cancer treatment research heading offshore as local patients miss out
11 March 2026 - Newsreader Will McDonald is six years into his fight with aggressive prostate cancer. He wants all Australians ...
Posted by Michael Wonder on 10 Mar 2026
Redx’s RXC008 granted US FDA fast track designation for fibrostenotic Crohn’s disease
10 March 2026 - Redx Pharma announces that the US FDA has granted fast track designation to RXC008, a GI ...
Posted by Michael Wonder on 10 Mar 2026
FDA approves first treatment for patients with cerebral folate transport deficiency
10 March 2026 - The US FDA today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of ...
Posted by Michael Wonder on 10 Mar 2026
Sangamo Therapeutics advances rolling submission of BLA to US FDA for ST-920 in Fabry disease
9 March 2026 - Sangamo Therapeutics today announced advancement of the rolling submission of a BLA to the FDA seeking ...
Posted by Michael Wonder on 10 Mar 2026
ImmunityBio announces resubmission of supplemental BLA to the FDA for Anktiva plus BCG in BCG unresponsive NMIBC with papillary disease following agency review of additional data
9 March 2026 - ImmunityBio today announced that the US FDA has acknowledged receipt of its supplemental biologics license application ...