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RSS FeedPosted by Michael Wonder on 14 Dec 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab as a treatment for patients with relapsing forms of multiple sclerosis
14 December 2021 - Prescription Drug User Fee Act goal date of 28 September 2022. ...
Posted by Michael Wonder on 14 Dec 2021
EMA reviewing new data on effectiveness of Lagevrio (molnupiravir) for the treatment of COVID-19
14 December 2021 - Following EMA’s interim recommendations to support national authorities who may decide on early use of Lagevrio ...
Posted by Michael Wonder on 14 Dec 2021
FDA publishes discussion paper and seeks public input on 3D printing of medical devices at the point of care
10 December 2021 - Today, the U.S. FDA published a discussion paper regarding 3D printing medical devices at the point of ...
Posted by Michael Wonder on 14 Dec 2021
Access Consortium statement on COVID-19 medicines
14 December 2021 - Vaccines have played a critical role in fighting the COVID-19 pandemic. However, medicines can still play ...
Posted by Michael Wonder on 14 Dec 2021
Galderma receives FDA approval for new Sculptra label, offering more options to aesthetic partners
13 December 2021 - New label update allows for immediate use after reconstitution and more convenient administration of Sculptra with the ...
Posted by Michael Wonder on 14 Dec 2021
mRNA manufacturing facility will deliver long term health benefits for Australians
14 December 2021 - Medicines Australia welcomes the announcement that Australia will manufacture mRNA vaccines in a deal struck with ...
Posted by Michael Wonder on 13 Dec 2021
EMA publishes agenda for 13-16 CHMP meeting
13 December 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 13 Dec 2021
Veru announces FDA approval of Entadfi, a new treatment for benign prostatic hyperplasia
13 December 2021 - Commercialisation will start early calendar year 2022. ...
Posted by Michael Wonder on 13 Dec 2021
Pfizer/BioNTech vaccine approved for children by Swiss regulator
10 December 2021 - The Swiss medical regulator has approved the use of Pfizer/BioNTech’s Covid-19 vaccine for children aged five to ...
Posted by Michael Wonder on 13 Dec 2021
InterVene’s BlueLeaf Endovenous Valve Formation System granted breakthrough device designation by the FDA
13 December 2021 - InterVene announced today that it has received breakthrough device designation by the FDA for the company’s BlueLeaf ...
Posted by Michael Wonder on 13 Dec 2021
Moderna vaccine deal to produce 100 million doses in Melbourne reached by Federal and Victorian Governments
13 December 2021 - Australia is poised to become the largest producer of mRNA vaccines outside the US and Europe ...
Posted by Michael Wonder on 13 Dec 2021
European Commission approves Pfizer's Cibinqo (abrocitinib) for the treatment of adults with moderate to severe atopic dermatitis
10 December 2021 - Cibinqo is a once daily oral treatment with proven efficacy demonstrated in a large scale clinical ...
Posted by Michael Wonder on 13 Dec 2021
International regulators recommend use of remote inspections as complementary tool beyond pandemic
13 December 2021 - Remote inspections have been useful in maintaining regulatory oversight during the COVID-19 pandemic, but cannot fully replace ...
Posted by Michael Wonder on 13 Dec 2021
ACCC helps to protect Australians against medicine shortages caused by COVID-19
10 December 2021 - Medicine shortages from the COVID-19 pandemic will continue to be actively managed by Medicines Australia and ...
Posted by Michael Wonder on 13 Dec 2021
Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced non-small-cell lung cancer with EGFR exon 20 insertion mutations
10 December 2021 - Janssen EMEA receives conditional marketing authorisation for Rybrevant (amivantamab), the first treatment approved for patients with advanced ...