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RSS FeedPosted by Michael Wonder on 15 Sep 2020
US FDA grants fast track designation to Jardiance (empagliflozin) to improve outcomes following a heart attack
15 September 2020 - This fast track designation for empagliflozin emphasises the urgent need for potential treatments that may improve outcomes ...
Posted by Michael Wonder on 15 Sep 2020
Ziopharm Oncology granted rare paediatric disease designation for controlled IL-12 for the treatment of DIPG
14 September 2020 - -- Ziopharm Oncology today announced that the U.S. FDA has granted rare paediatric disease designation to ...
Posted by Michael Wonder on 15 Sep 2020
European Medicines Agency approves safety label update for Novartis Beovu
14 September 2020 - Novartis worked with the EMA to update the Beovu (brolucizumab) label to guide physicians in their treatment ...
Posted by Michael Wonder on 15 Sep 2020
Vertex announces European Medicines Agency type II variation marketing authorisation application validation for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in people with one copy of the F508del mutation
14 September 2020 - Vertex Pharmaceuticals today announced the EMA has validated a type II variation marketing authorisation application for ...
Posted by Michael Wonder on 14 Sep 2020
EMA publishes agenda for 14-17 September CHMP meeting
14 September 2020 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Sep 2020
Vaccine makers keep safety details quiet, alarming scientists
13 September 2020 - Researchers say drug companies need to be more open about how vaccine trials are run to reassure ...
Posted by Michael Wonder on 14 Sep 2020
ESSA Pharma announces fast track designation granted by the FDA to EPI-7386 for the treatment of metastatic castration-resistant prostate cancer
14 September 2020 - ESSA Pharma today announced that the US FDA granted fast track designation to EPI-7386, its oral ...
Posted by Michael Wonder on 14 Sep 2020
Sol-Gel Technologies announces FDA acceptance for filing of new drug application for Epsolay for the treatment of inflammatory lesions of rosacea
10 September 2020 - Potential to be first FDA-approved single-agent benzoyl peroxide prescription drug product. ...
Posted by Michael Wonder on 14 Sep 2020
Mallinckrodt receives a complete response letter from the U.S. FDA for terlipressin for the treatment of hepatorenal syndrome type 1
14 September 2020 - Company remains committed to working with FDA toward an approval for this important potential therapy. ...
Posted by Michael Wonder on 14 Sep 2020
Making best use of big data for public health: publication of the Big Data Steering Group workplan for 2020-21
14 September 2020 - The Big Data Steering Group set up by EMA and the Heads of Medicines Agencies has ...
Posted by Michael Wonder on 14 Sep 2020
FDA grants Dupixent (dupilumab) breakthrough therapy designation for eosinophilic oesophagitis
14 September 2020 - There are currently no FDA approved treatments for this chronic type 2 inflammatory disease that damages the ...
Posted by Michael Wonder on 14 Sep 2020
Pfizer CEO 'preparing' for likelihood of vaccine approval before end of year
13 September 2020 - Pharmaceutical company Pfizer is preparing for the likelihood of regulators approving the coronavirus vaccine the company ...
Posted by Michael Wonder on 14 Sep 2020
Revolutionary cancer medicine Vitrakvi shrinks tumours in days
14 September 2020 - Doctors are amazed by a new cancer medicine offering Australian kids a new lease on life, but ...
Posted by Michael Wonder on 14 Sep 2020
Trump pressed for plasma therapy. Officials worry, is an unvetted vaccine next?
12 September 2020 - New details of how the president has demanded faster action from health agencies help explain the intensifying ...
Posted by Michael Wonder on 11 Sep 2020
Health Canada approves Tremfya (guselkumab injection), a first in class, selective interleukin 23 inhibitor for active psoriatic arthritis
10 September 2020 - Data show Tremfya significantly improved signs and symptoms in joints, skin, and soft tissue of adults with ...