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 28 Jul 2021
Lyndra Therapeutics’ investigational oral, weekly opioid use disorder treatment LYN-014 granted fast track designation by FDA
27 July 2021 - LYN-014 has the potential to address significant public health concerns about access to opioid use disorder treatment and ...
Posted by Michael Wonder on 27 Jul 2021
J&J and Pfizer quietly resolve Remicade biosimilar lawsuit
27 July 2021 - In 2017, Pfizer filed a lawsuit against J&J alleging that the company undertook anticompetitive practices in a ...
Posted by Michael Wonder on 27 Jul 2021
Hospital costs, not drug prices, are the real US health care scandal
27 July 2021 - Medical monopolies have allowed inflation to get out of hand, but American politicians are not paying attention. ...
Posted by Michael Wonder on 27 Jul 2021
$3.3 million to support Australians living with a rare disease
27 July 2021 - The Australian Government is providing $3.3 million to support the approximate two million Australians living with a ...
Posted by Michael Wonder on 27 Jul 2021
Sol-Gel Technologies announces FDA approval of Twyneo
27 July 2021 - Twyneo utilizes Sol-Gel’s proprietary microencapsulation technology and is patent protected until 2038. ...
Posted by Michael Wonder on 27 Jul 2021
How Biogen found a believer: at the FDA, a hard nosed regulator was won over on controversial Alzheimer’s drug
27 July 2021 - When the drug maker Biogen pitched its Alzheimer’s treatment to a panel of independent experts last ...
Posted by Michael Wonder on 27 Jul 2021
Day One receives FDA rare paediatric disease designation for DAY101 for the treatment of paediatric low grade glioma
27 July 2021 - Day One Biopharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 27 Jul 2021
FDA approves Keytruda (pembrolizumab) for treatment of patients with high-risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, then continued as single agent as adjuvant treatment after surgery
27 July 2021 - Keytruda is now approved in the US for 30 indications. ...
Posted by Michael Wonder on 27 Jul 2021
Health Canada releases What We Heard Report from the public engagement on the National Strategy for Drugs for Rare Diseases
26 July 2021 - Too many Canadians are struggling to access the drugs they need, especially if they have a rare ...
Posted by Michael Wonder on 26 Jul 2021
Using updated PubMed: new features and functions to enhance literature searches
26 July 2021 - In the past 2 years, PubMed has been updated to improve functionality and add important new features, ...
Posted by Michael Wonder on 26 Jul 2021
Evren Technologies receives FDA breakthrough device designation for the Phoenix
21 July 2021 - Evren Technologies announced today that its non-invasive Phoenix earbud device received Breakthrough Device Designation from the ...
Posted by Michael Wonder on 26 Jul 2021
FDA asks Pfizer, Moderna to test their vaccines in more children to help rule out safety issues
26 July 2021 - Federal regulators have requested that vaccine companies expand their trials to test coronavirus shots in several ...
Posted by Michael Wonder on 26 Jul 2021
BeiGene announces approval in Canada of Brukinsa (zanubrutinib) for the treatment of patients with mantle cell lymphoma
26 July 2021 - Second approval for BTK inhibitor Brukinsa in Canada. ...
Posted by Michael Wonder on 26 Jul 2021
TGA international engagement strategy 2021-2025
26 July 2021 - The TGA's International Engagement Strategy 2021-2025 describes how working with our international regulatory counterparts will benefit Australians ...
Posted by Michael Wonder on 26 Jul 2021
Shingrix approved in the US for prevention of shingles in immunocompromised adults
26 July 2021 - GlaxoSmithKline today announced that the US FDA has approved Shingrix (zoster vaccine recombinant, adjuvanted) for the prevention ...