Blog
RSS FeedPosted by Michael Wonder on 11 Aug 2021
New Alzheimer's drug aducanumab is dividing doctors and patients, as the TGA weighs up its risk-benefit profile
12 August 2021 - After a decades-long career as a biology teacher, John Rodgers applies the strict logic of a ...
Posted by Michael Wonder on 11 Aug 2021
Turning Point Therapeutics granted sixth regulatory designation for repotrectinib
11 August 2021 - Fast track designation granted by FDA in ROS1 positive advanced non-small-cell lung cancer patients pretreated with one ...
Posted by Michael Wonder on 11 Aug 2021
Swing Therapeutics receives FDA breakthrough device designation for digital therapeutic for the management of fibromyalgia, launches real world study
11 August 2021 - Approach based on acceptance and commitment therapy and a foundational clinically validated digital program licensed from University ...
Posted by Michael Wonder on 11 Aug 2021
Update on US regulatory review of roxadustat in anaemia of chronic kidney disease
11 August 2021 - The US FDA has issued a complete response letter regarding the new drug application for roxadustat ...
Posted by Michael Wonder on 11 Aug 2021
Pressure builds for full FDA approval of vaccines
11 August 2021 - Pressure is building for the FDA to fully approve the COVID-19 vaccine, a step that could ...
Posted by Michael Wonder on 11 Aug 2021
TGA head John Skerritt says NSW death toll would be much higher without AstraZeneca vaccine
11 August 2021 - The head of the national medical regulator says NSW would be recording “dozens” of covid deaths a ...
Posted by Michael Wonder on 11 Aug 2021
TGA grants provisional determination to MSD's anti-viral COVID-19 treatment molnupiravir
10 August 2021 - On 9 August 2021 the Therapeutic Goods Administration granted provisional determination to MSD in relation to ...
Posted by Michael Wonder on 10 Aug 2021
Dermavant announces FDA acceptance for filing of new drug application for tapinarof cream for the treatment of adults with plaque psoriasis
10 August 2021 - FDA PDUFA action expected in Q2 2022. ...
Posted by Michael Wonder on 10 Aug 2021
FDA accepts application for Merck’s Keytruda (pembrolizumab) as single agent for certain patients with MSI-H/dMMR advanced endometrial carcinoma
10 August 2021 - Merck today announced that the U.S. FDA has accepted for review a new supplemental biologics license application ...
Posted by Michael Wonder on 10 Aug 2021
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) as adjuvant therapy in certain patients with renal cell carcinoma following surgery
10 August 2021 - Application based on KEYNOTE-564, a Phase 3 trial that evaluated adjuvant immunotherapy in renal cell carcinoma. ...
Posted by Michael Wonder on 10 Aug 2021
Final guidance on metastasis-free survival in non-metastatic castration resistant prostate cancer released by the FDA
10 August 2021 - The FDA announced its finalised guidance on the use of metastases-free survival as an outcome for ...
Posted by Michael Wonder on 10 Aug 2021
After court defeat, FDA shifts to regulating some drugs as devices
9 August 2021 - The US FDA is informing stakeholders and the public that it will soon begin implementing a ...
Posted by Michael Wonder on 10 Aug 2021
Acer Therapeutics and Relief Therapeutics announce submission of a new drug application to the U.S. FDA for ACER-001 for treatment of urea cycle disorders
9 August 2021 - Acer Therapeutics and Relief Therapeutics today announced the submission of a new drug application to the U.S. ...
Posted by Michael Wonder on 10 Aug 2021
Liminal BioSciences announces sale of priority review voucher for USD105 million
9 August 2021 - Liminal BioSciences announced today that its subsidiary ProMetic Biotherapeutics has entered into a definitive agreement to ...
Posted by Michael Wonder on 10 Aug 2021
Moderna COVID-19 vaccine gets Swiss approval for 12 to 17 year-olds
9 August 2021 - Swissmedic has approved the Moderna COVID-19 vaccine for 12- to 17-year-olds, the Swiss agency said on ...