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 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 ...
Posted by Michael Wonder on 26 Jul 2021
Full FDA approval is needed to overcome vaccine hesitancy
26 July 2021 - As the Delta variant spreads, what is the agency waiting for? ...
Posted by Michael Wonder on 26 Jul 2021
NICE and partners announce this year’s theme for World Evidence Based Healthcare Day
26 July 2021 - NICE and six other global leaders in evidence based healthcare will this year shine a light ...
Posted by Michael Wonder on 26 Jul 2021
Drug pricing will make or break Democrats’ health care agenda
26 July 2021 - Committee leaders seek common ground on drug pricing. ...
Posted by Michael Wonder on 26 Jul 2021
Iterum Therapeutics receives complete response letter from U.S. FDA for oral sulopenem
26 July 2021 - Iterum Therapeutics today announced that it received a complete response letter from the U.S. FDA for its ...
Posted by Michael Wonder on 26 Jul 2021
Aadi Bioscience announces FDA acceptance and priority review for the new drug application of Fyarro for the treatment of advanced malignant PEComa
26 July 2021 - FDA grants priority review and sets PDUFA target action date of 26 November 2021 ...
Posted by Michael Wonder on 26 Jul 2021
Pfizer and BioNTech to provide U.S. Government with an additional 200 million doses of COVID-19 vaccine to help meet continued need for vaccine supply in the U.S.
23 July 2021 - Dose deliveries for new order expected to occur from October 2021 through April 2022. ...
Posted by Michael Wonder on 26 Jul 2021
Rhythm Pharmaceuticals announces European Commission authorisation of Imcivree (setmelanotide) for the treatment of obesity and control of hunger associated with POMC, PCSK1 and LEPR deficiency
23 July 2021 - First ever authorised treatment option in the European Union for these rare genetic diseases of obesity. ...
Posted by Michael Wonder on 26 Jul 2021
Bristol Myers Squibb statement on Opdivo (nivolumab) monotherapy post sorafenib hepatocellular carcinoma U.S. indication
23 July 2021 - In consultation with the U.S. FDA, Bristol Myers Squibb has made the difficult decision to voluntarily withdraw ...
Posted by Michael Wonder on 26 Jul 2021
Ultomiris recommended for approval in the EU by CHMP for children and adolescents with paroxysmal nocturnal haemoglobinuria
26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety ...
Posted by Michael Wonder on 25 Jul 2021
COVID-19 demand leads to Australian shortages of rheumatoid arthritis drug
25 July 2021 - Australia is facing shortages of a rheumatoid arthritis drug that has been used to treat COVID-19 ...
Posted by Michael Wonder on 25 Jul 2021
Australia is racing to make mRNA COVID vaccines here — but can we do it without big pharma?
26 July 2021 - Australia is one of many nations seeking to make the type of COVID-19 vaccine pioneered by Pfizer ...
Posted by Michael Wonder on 25 Jul 2021
EMA CHMP adopts positive opinion recommending authorisation for the use of the Moderna COVID-19 Vaccine in adolescents (12-17 years of age) in the European Union
23 July 2021 - . 23, 2021-- Moderna today announced that the EMA's CHMP adopted a positive opinion recommending marketing authorisation ...