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RSS FeedPosted by Michael Wonder on 24 Feb 2021
Bladder cancer drug shortage resolved with Health Canada approval
24 February 2021 - Verity-BCG bladder cancer treatment available for Canadian patients in the spring. ...
Posted by Michael Wonder on 24 Feb 2021
TGA reviewing COVID-19 tests to rule out issues diagnosing variants
24 February 2021 - Adjunct Professor John Skerritt has tasked the nation’s medical regulator with ensuring COVID-19 tests are successfully ...
Posted by Michael Wonder on 24 Feb 2021
ViiV Healthcare submits supplemental new drug application to US FDA for expanded use of Cabenuva (cabotegravir, rilpivirine) as an HIV treatment for use every 2 months
24 February 2021 - ViiV Healthcare announced today the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 24 Feb 2021
Locate Bio’s Chondro3 granted FDA breakthrough device designation
24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...
Posted by Michael Wonder on 24 Feb 2021
EMA starts rolling review of Celltrion antibody regdanvimab for COVID-19
24 February 2021 - EMA’s CHMP has started a ‘rolling review’ of data on the monoclonal antibody regdanvimab (also known ...
Posted by Michael Wonder on 24 Feb 2021
Health Canada approves Dupixent (dupilumab) as the first biologic for the treatment of moderate to severe atopic dermatitis in children aged 6 to 11 years
23 February 2021 - Dupixent is the only biologic medicine approved to treat atopic dermatitis for this patient population. ...
Posted by Michael Wonder on 24 Feb 2021
U.S. FDA accepts for priority review Pfizer's application for Ticovac (tick-borne encephalitis vaccine)
23 February 2021 - If approved, the vaccine may help reduce the risk of tick-borne encephalitis for people traveling to endemic ...
Posted by Michael Wonder on 24 Feb 2021
Inovise receives breakthrough device designation for novel non-invasive system to remotely monitor risk of decompensation in heart failure patients
23 February 2021 - Inovise Medical today announced the U.S. FDA has granted breakthrough device designation for its Audicor heart failure ...
Posted by Michael Wonder on 23 Feb 2021
TGA bans Pfizer, AstraZeneca brand mentions in COVID-19 vaccine advertising
24 February 2021 - Pharmacies, GPs and healthcare organisations will be banned from displaying advertisements identifying whether they are using ...
Posted by Michael Wonder on 23 Feb 2021
FDA approves EndoClot Hemostat to manage GI bleeding
23 February 2021 - A unique product to rapidly and reliably control bleeding during GI procedures. ...
Posted by Michael Wonder on 23 Feb 2021
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures
24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...
Posted by Michael Wonder on 23 Feb 2021
Amgen submits supplemental new drug application for Otezla (apremilast) for adults with mild to moderate plaque psoriasis
22 February 2021 - Filing based on data from Phase 3 ADVANCE trial. ...
Posted by Michael Wonder on 23 Feb 2021
AstraZeneca vaccine review is in the 'final stages,' Health Canada says
22 February 2021 - Health Canada has received all the necessary scientific data but questions for the company remain. ...
Posted by Michael Wonder on 22 Feb 2021
Switzerland could sell or give away AstraZeneca doses if regulator dithers
21 February 2021 - A lack of green light from medicines regulator SwissMedic could see 5.3 million doses ordered by Switzerland ...
Posted by Michael Wonder on 22 Feb 2021
Piccolo Medical receives U.S. FDA clearance of its SmartPICC system for the positioning of peripherally inserted central catheters
22 February 2021 - Piccolo Medical announces that it has received FDA clearance of its SmartPICC System. ...