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RSS FeedPosted by Michael Wonder on 21 Jun 2021
Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers
21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients ...
Posted by Michael Wonder on 21 Jun 2021
Bayer submits regulatory applications for oncology treatment combination of copanlisib and rituximab in the U.S. and EU
21 June 2021 - Bayer today announced the submission of a supplemental new drug application to the U.S. FDA and a ...
Posted by Michael Wonder on 21 Jun 2021
FDA approves first oral blood thinning medication for children
21 June 2021 - Today, the U.S. FDA approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less ...
Posted by Michael Wonder on 21 Jun 2021
EMA publishes agenda for 21-24 June CHMP meeting
21 June 2021 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jun 2021
Agios submits new drug application to FDA for mitapivat for treatment of adults with pyruvate kinase deficiency
21 June 2021 - Agios Pharmaceuticals today announced that it has submitted a new drug application for mitapivat to the U.S. ...
Posted by Michael Wonder on 21 Jun 2021
Sensome receives FDA breakthrough device designation for its AI powered stroke guidewire
21 June 2021 - Sensome announced today that it has been granted a Breakthrough Device designation by the Center of Devices ...
Posted by Michael Wonder on 21 Jun 2021
Factors associated with generic drug uptake in the United States, 2012 to 2017
19 June 2021 - In the United States, brand-name prescription drugs remain expensive until market exclusivity ends and lower cost generics ...
Posted by Michael Wonder on 21 Jun 2021
TGA not expecting Novavax quality data until September
20 June 2021 - Australian’s medicines regulator says it does not expect key data from the country’s third major COVID-19 ...
Posted by Michael Wonder on 21 Jun 2021
Cystic fibrosis life-altering drug nearing patient access across the country: Health Canada
20 June 2021 - For the cystic fibrosis community, persistence and constant belief are paying off. ...
Posted by Michael Wonder on 20 Jun 2021
AstraZeneca welcomes court ruling on supply of its COVID-19 vaccine to Europe
18 June 2021 - AstraZeneca today welcomed the ruling by the Court of First Instance in Brussels. The European Commission had ...
Posted by Michael Wonder on 20 Jun 2021
US plays catch-up with Europe over biosimilar patents
17 June 2021 - Moves to ease market access for generic drug makers are gaining momentum. ...
Posted by Michael Wonder on 20 Jun 2021
United States to spend $4.2 billion on anti-viral pills and other treatments for COVID-19
18 June 2021 - The United States is devoting $US3.2 billion ($4.2 billion) to speed development of antiviral pills to treat ...
Posted by Michael Wonder on 19 Jun 2021
European regulator EMA says it won't set 50% efficacy threshold for COVID shots
18 June 2021 - The EMA said on Thursday it would not impose a 50% efficacy threshold for COVID-19 vaccines, ...
Posted by Michael Wonder on 18 Jun 2021
The FDA grants a breakthrough device designation to the MIScoli, an innovative vertebral body tethering device to treat idiopathic scoliosis
18 June 2021 - Spinologics announced today that the U.S. FDA has granted the company a breakthrough device designation for its ...
Posted by Michael Wonder on 18 Jun 2021
3D bioprinting can help end organ transplant waitlists — if the FDA stops delaying
18 June 2021 - Right now, more than 100,000 Americans are waiting for organ transplants. Due to a lack of ...