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 19 Jan 2022
FDA accepts for review Libtayo (cemiplimab-rwlc) in combination with chemotherapy for first-line treatment of advanced NSCLC
19 January 2022 - Regulatory filing recently submitted in the European Union. ...
Posted by Michael Wonder on 19 Jan 2022
Levo Therapeutics receives complete response letter from FDA for its new drug application for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome
18 January 2022 - Levo Therapeutics announced today that it has received a complete response letter from the U.S. FDA regarding ...
Posted by Michael Wonder on 19 Jan 2022
CANbridge Pharmaceuticals CAN108 new drug application for Alagille syndrome accepted by China’s National Medical Products Administration
17 January 2022 - Priority review expected to be granted. ...
Posted by Michael Wonder on 19 Jan 2022
Early benefit assessment for new drugs 2021: G-BA sets a record with 146 completed procedures
10 January 2022 - At the beginning of the year, the Federal Joint Committee (G-BA) took stock of its assessment of ...
Posted by Michael Wonder on 19 Jan 2022
FDA grants breakthrough device designation to Diadem's AlzoSure predict prognostic blood test for the early prediction of Alzheimer's disease
18 January 2022 - First prognostic blood test that can predict likely progression to Alzheimer's disease up to six years in ...
Posted by Michael Wonder on 19 Jan 2022
NeuroMetrix receives FDA breakthrough device designation for treatment of chronic chemotherapy induced peripheral neuropathy with its wearable neurostimulation technology
18 January 2022 - NeuroMetrix today announced that its Quell technology has received breakthrough designation from the U.S. FDA for reducing ...
Posted by Michael Wonder on 18 Jan 2022
Discussion paper and online questionnaire for information session on a potential pan-Canadian formulary
18 January 2022 - On 18 January 2022, the advisory panel and CADTH will host an information session on the panel’s ...
Posted by Michael Wonder on 18 Jan 2022
Antares Pharma receives FDA fast track designation for ATRS-1902 for adrenal crisis rescue
18 January 2022 - Antares Pharma today announced that the U.S. FDA has granted fast track designation for ATRS-1902 for adrenal ...
Posted by Michael Wonder on 18 Jan 2022
TGA ‘knowingly putting pharmacists in serious danger’
18 January 2022 - The pharmacists’ union has accused the medical regulator of putting workers and customers at risk of ...
Posted by Michael Wonder on 18 Jan 2022
TGA in review (2021)
19 January 2022 - Using a liberal definition of what constitutes a 'new medicine', we have determined the TGA approved ...
Posted by Michael Wonder on 18 Jan 2022
Celularity receives fast track designation from U.S. FDA for its NK cell therapy CYNK-101 in development for the first-line treatment of advanced HER2/neu positive gastric and gastro-oesophageal junction cancers
18 January 2022 - CYNK-101 is an investigational genetically modified natural killer cell therapy designed to synergise with antibody therapeutics for ...
Posted by Michael Wonder on 18 Jan 2022
COVID-19: latest safety data provide reassurance about use of mRNA vaccines during pregnancy
18 January 2022 - Vaccination remains a major pillar of the response to COVID-19, particularly as variants of the virus continue ...
Posted by Michael Wonder on 18 Jan 2022
bluebird provides update on FDA review timelines for betibeglogene autotemcel for beta thalasszemia and elivaldogene autotemcel for cerebral adrenoleukodystrophy
18 January 2022 - FDA PDUFA goal dates for both therapies extended by three months. ...
Posted by Michael Wonder on 18 Jan 2022
Gilead withdraws use of Zydelig to treat two types of cancer
14 January 2022 - Gilead Sciences on Friday notified the U.S. health regulator of its decision to voluntarily withdraw the ...
Posted by Michael Wonder on 18 Jan 2022
Canada approves Pfizer COVID drug
18 January 2022 - Canada’s health regulator has approved a pill by Pfizer that treats the effects of COVID-19. ...