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RSS FeedPosted 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. ...
Posted by Michael Wonder on 17 Jan 2022
Swissmedic grants temporary authorisation to Xevudy for COVID-19 patients
14 January 2022 - Corona medication Xevudy from GSK (sotrovimab) granted temporary authorisation in Switzerland ...
Posted by Michael Wonder on 17 Jan 2022
Serb receives EU approval for Voraxaze (glucarpidase) as rescue therapy for high dose methotrexate toxicity
14 January 2022 - Serb and BTG Specialty Pharmaceuticals today announced that the European Commission has granted marketing authorisation for ...
Posted by Michael Wonder on 17 Jan 2022
TGA approves ‘game changing’ ovarian cancer drug bringing new hope to patients
18 January 2022 - Federal health authorities have approved a breakthrough drug for ovarian cancer, bringing a game-changing treatment option ...
Posted by Michael Wonder on 17 Jan 2022
TGA recognises the Gamaleya Institute vaccine (Sputnik V, Russian Federation) for international travel to Australia
17 January 2022 - Today, the TGA determined that an additional COVID-19 vaccine, the two dose course of the Gamaleya ...
Posted by Michael Wonder on 17 Jan 2022
Enhertu granted priority review in the U.S. for patients with HER2 positive metastatic breast cancer treated with a prior anti-HER2 based regimen
17 January 2022 - Application being evaluated under FDA Real-Time Oncology Review and Project Orbis ...
Posted by Michael Wonder on 17 Jan 2022
ATAGI update following weekly COVID-19 meeting (12 January 2022)
17 January 2022 - Previously, severely immunocompromised people aged 12 years and older were recommended to receive a third primary dose ...
Posted by Michael Wonder on 16 Jan 2022
Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...