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 Aug 2022
SK bioscience submits application for conditional marketing authorisation of COVID-19 vaccine, SKYCovion to European Medicines Agency
1 August 2022 - SK bioscience will accelerate to apply for emergency use listing to the World Health Organization. ...
Posted by Michael Wonder on 01 Aug 2022
Advancing innovative clinical trials to efficiently deliver medicines to patients
1 August 2022 - Complex innovative designs in clinical trials have the potential to increase efficiency and lower the cost of ...
Posted by Michael Wonder on 01 Aug 2022
FDA may approve first OTC birth control pill In U.S.: more novel prescription to OTC switches could be on tap
1 August 2022 - The French drug maker HRA Pharma is seeking approval from the Food and Drug Administration (FDA) ...
Posted by Michael Wonder on 01 Aug 2022
Listing breakthrough brings hope for people with spinal condition
1 August 2022 - Adults with debilitating spinal muscular atrophy will for the first time have access to a subsidised ...
Posted by Michael Wonder on 01 Aug 2022
Marinus Pharmaceuticals announces U.S. commercial launch of Ztalmy (ganaxolone) for seizures associated with CDKL5 deficiency disorder
1 August 2022 - ZTALMY One™ offers comprehensive patient services, including access and prescription drug support. ...
Posted by Michael Wonder on 01 Aug 2022
Pharming receives accelerated assessment in Europe for leniolisib for the treatment of rare immunodeficiency, APDS
1 August 2022 - Pharming is on track to submit its marketing authorisation application for leniolisib in H2 2022. ...
Posted by Michael Wonder on 01 Aug 2022
Tell your Senator to lower Rx drug prices now
1 August 2022 - The Senate is preparing to vote on whether to finally allow Medicare to negotiate for lower ...
Posted by Michael Wonder on 01 Aug 2022
Scynexis announces U.S. FDA acceptance and priority review of the supplemental new drug application for Brexafemme (ibrexafungerp) for prevention of recurrent vaginal yeast infections
1 August 2022 - Submission has been granted priority review and given a target regulatory decision date of 30 November 2022. ...
Posted by Michael Wonder on 01 Aug 2022
Stelara (ustekinumab) approved by the U.S. FDA to treat paediatric patients with active psoriatic arthritis
1 August 2022 - As the first and only biologic targeting both cytokines interleukin-12 and interleukin-23, Stelara provides a new therapeutic ...
Posted by Michael Wonder on 01 Aug 2022
ALX Oncology’s evorpacept receives fast track designation from FDA as first-line treatment for head and neck squamous cell carcinoma
1 August 2022 - ALX Oncology today announced that the U.S. FDA has granted fast track designation to evorpacept, a next ...
Posted by Michael Wonder on 01 Aug 2022
Changes to cost recovery arrangements from 1 August 2022
1 August 2022 - PBS cost recovery fees and charges have now been updated with the fees that will apply ...
Posted by Michael Wonder on 01 Aug 2022
HSE weighs up impact of obesity drug that costs 250 Euros a month
31 July 2022 - Health authorities are evaluating whether a game changing new obesity drug should be used in Ireland ...
Posted by Michael Wonder on 01 Aug 2022
Gamida Cell announces FDA acceptance of biologics license application for omidubicel with priority review
1 August 2022 - PDUFA target action date is 30 January 2023. ...
Posted by Michael Wonder on 01 Aug 2022
Changes to PBS listing of hydromorphone oral solution
1 August 2022 - Changes to the PBS listing of hydromorphone hydrochloride 1 mg/mL oral solution (473 mL) are being ...
Posted by Michael Wonder on 01 Aug 2022
Mum fears dance loving toddler will lose ability to walk without unfunded drug
1 August 2022 - An Auckland toddler who loves to dance may soon be unable to walk or stand if ...