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RSS FeedPosted by Michael Wonder on 25 Feb 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases announce the submission of a marketing authorisation application to the European Medicines Agency for PRX-102 for the treatment of Fabry disease
24 February 2022 - Protalix BioTherapeutics and Chiesi Global Rare Diseases today announced the submission of a marketing authorisation application via ...
Posted by Michael Wonder on 25 Feb 2022
Noninvasix receives FDA breakthrough device designation for non-invasive monitoring technology for sepsis
23 February 2022 - LIVOx is first monitoring device to non-invasively monitor sepsis by detecting a key indicator of septic ...
Posted by Michael Wonder on 25 Feb 2022
TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, Evusheld) - for pre-exposure prevention (prophylaxis) of COVID-19
25 February 2022 - On 24 February 2022, the TGA granted provisional approval to AstraZeneca for its tixagevimab and cilgavimab ...
Posted by Michael Wonder on 24 Feb 2022
Viz.ai receives FDA 510(k) clearance for Viz Aneurysm
24 February 2022 - Viz.ai today announced it has received U.S. FDA 510(k) clearance for Viz Aneurysm. ...
Posted by Michael Wonder on 24 Feb 2022
United Therapeutics Corporation reports fourth quarter and full year 2021 financial results
24 February 2022 - Major amendment to Tyvaso DPI new drug application pushes FDA decision date to May 2022. ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
24 February 2022 - EMA’s CHMP has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where ...
Posted by Michael Wonder on 24 Feb 2022
FDA grants BI 1015550 breakthrough therapy designation for idiopathic pulmonary fibrosis
24 February 2022 - Designation is supported by Phase II efficacy and safety data that will be presented at ATS 2022. ...
Posted by Michael Wonder on 24 Feb 2022
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with Bardet-Biedl syndrome and Alström syndrome
24 February 2022 - FDA sets updated PDUFA goal date of 16 June 2022. ...
Posted by Michael Wonder on 24 Feb 2022
FDA approves treatment for wider range of patients with heart failure
24 February 2022 - Today, the U.S. FDA approved Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization ...
Posted by Michael Wonder on 24 Feb 2022
EMA recommends approval of Spikevax for children aged 6 to 11
24 February 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax to include use ...
Posted by Michael Wonder on 24 Feb 2022
COVID-19 vaccine weekly safety report (24 February 2022)
24 February 2022 - To 20 February 2022, the TGA has received 451 reports which have been assessed as likely to ...
Posted by Michael Wonder on 24 Feb 2022
ATAGI recommendations on the use of Spikevax (Moderna) COVID-19 vaccine in children aged 6 to 11 years
23 February 2022 - The Australian Technical Advisory Group on Immunisation (ATAGI) has made recommendations for the use of the Moderna ...
Posted by Michael Wonder on 23 Feb 2022
FDA approves nalmefene hydrochloride 2 mg/2 mL injection for the treatment of known or suspected opioid overdose with natural or synthetic opioids
23 February 2022 - Purdue Pharma announced today that FDA has approved its abbreviated new drug application for nalmefene hydrochloride 2 ...
Posted by Michael Wonder on 23 Feb 2022
FDA permits marketing of first condom specifically indicated for anal intercourse
23 February 2022 - Other FDA cleared condoms can continue to be used for contraception and to prevent sexually transmitted infections. ...
Posted by Michael Wonder on 23 Feb 2022
Theragnostics announces US FDA approval for its radiodiagnostic imaging drug NephroScan (kit for the preparation of Technetium Tc 99m succimer injection)
23 February 2022 - NephroScan is now U.S. FDA approved for the preparation of Tc-99m DMSA. ...