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RSS FeedPosted by Michael Wonder on 08 Apr 2021
ATAGI statement on AstraZeneca vaccine in response to new vaccine safety concerns
8 April 2021 - A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) on the AstraZeneca COVID-19 vaccine in ...
Posted by Michael Wonder on 08 Apr 2021
Teva Canada announces new auto-injector for Ajovy for the preventive treatment of migraine in adults
8 April 2021 - Ajovy now offers patients greater flexibility with two dosing options available in both an auto-injector and a ...
Posted by Michael Wonder on 08 Apr 2021
‘Before end of this year’: Novavax COVID vaccine could be months away
8 April 2021 - Regulatory approvals for the third pillar of Australia’s vaccine strategy may not be obtained until the ...
Posted by Michael Wonder on 08 Apr 2021
AstraZeneca worldwide: who’s using the jab, and who’s not
9 April 2021 - A growing list of countries are either restricting or suspending the use of AstraZeneca vaccine amid it’s ...
Posted by Michael Wonder on 08 Apr 2021
Immutep achieves fast track designation from US FDA for EFTI, a soluble LAG-3 protein, in first-line recurrent/metastatic head & neck cancer
8 April 2021 - Fast track was granted based on the promising data package from Immutep, including from Immutep’s Phase ...
Posted by Michael Wonder on 08 Apr 2021
Dying patients wait in vain after Trump-era easing of drug law
6 April 2021 - Companies hold back experimental medications from those who want them most. They say they have good reasons, ...
Posted by Michael Wonder on 08 Apr 2021
The European Commission grants marketing authorisation for the new subcutaneous administration of Tysabri (natalizumab) to treat relapsing-remitting multiple sclerosis
7 April 2021 - The subcutaneous option provides a shorter administration time and expands access to treatment for patients and physicians ...
Posted by Michael Wonder on 08 Apr 2021
With millions vaccinated, rare side-effects of jabs are emerging
7 April 2021 - Sorting signal from noise. ...
Posted by Michael Wonder on 08 Apr 2021
Wider storage and transportation conditions for the Pfizer COVID-19 vaccine now approved
8 April 2021 - The Therapeutic Goods Administration has recently approved wider storage and transportation conditions for the Pfizer COVID-19 ...
Posted by Michael Wonder on 07 Apr 2021
FDA approves new dosing regimen for cetuximab
7 April 2021 - On 6 April 2021, the FDA approved a new dosage regimen of 500 mg/m2 as a ...
Posted by Michael Wonder on 07 Apr 2021
Hanmi's short bowel syndrome drug gets FDA fast track status
7 April 2021 - Hanmi Pharmaceutical said Wednesday that the U.S. Food and Drug Administration has granted fast-track designation to ...
Posted by Michael Wonder on 07 Apr 2021
FDA grants regular approval to sacituzumab govitecan for triple-negative breast cancer
7 April 2021 - Today the FDA granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics) for patients with unresectable locally ...
Posted by Michael Wonder on 07 Apr 2021
AbbVie submits regulatory applications for Skyrizi (risankizumab) in psoriatic arthritis to FDA and EMA
7 April 2021 - Submissions supported by two Phase 3 studies in patients with active psoriatic arthritis in which Skyrizi demonstrated ...
Posted by Michael Wonder on 07 Apr 2021
AstraZeneca’s COVID-19 vaccine: EMA finds possible link to very rare cases of unusual blood clots with low blood platelets
7 April 2021 - EMA confirms overall benefit-risk remains positive. ...
Posted by Michael Wonder on 07 Apr 2021
Pfizer announces extension of review of new drug application of abrocitinib for the treatment of moderate to severe atopic dermatitis
7 April 2021 - Pfizer today announced that the U.S. FDA has extended the priority review period for the new ...