Blog
RSS FeedPosted by Michael Wonder on 27 Feb 2021
FDA issues emergency use authorisation for third COVID-19 vaccine
27 February 2021 - Action advances fight against COVID-19, follows comprehensive evaluation of available safety, effectiveness and manufacturing quality information by ...
Posted by Michael Wonder on 27 Feb 2021
FDA approves first treatment for molybdenum cofactor deficiency type A
26 February 2021 - Today, the U.S. FDA approved Nulibry (fosdenopterin) for injection to reduce the risk of death due to ...
Posted by Michael Wonder on 26 Feb 2021
FDA authorises marketing of novel device to help protect athletes’ brains during head impacts
26 February 2021 - Today, the U.S. FDA authorised marketing of a new device intended to be worn around the neck ...
Posted by Michael Wonder on 25 Feb 2021
FDA approves targeted treatment for rare Duchenne muscular dystrophy mutation
25 February 2021 - Today, the U.S. FDA granted approval for Amondys 45 (casimersen) injection for the treatment of Duchenne muscular ...
Posted by Michael Wonder on 25 Feb 2021
Humira (adalimumab) receives FDA approval to treat paediatric patients living with moderately to severely active ulcerative colitis
24 February 2021 - Humira (adalimumab) is the first and only subcutaneous biologic treatment option for paediatric patients from 5 years ...
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 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. ...
Posted by Michael Wonder on 22 Feb 2021
FDA approves Libtayo (cemiplimab-rwlc) monotherapy for patients with first-line advanced non-small cell lung cancer with PD-L1 expression of ≥50%
22 February 2021 - This is the third approval for Libtayo in the U.S. ...
Posted by Michael Wonder on 18 Feb 2021
Additive Orthopaedics announces FDA approval of patient specific talus spacer, first approved in the U.S.
17 February 2021 - Company can now initiate commercial marketing, sale, and distribution of patient specific talus spacer implants. ...
Posted by Michael Wonder on 17 Feb 2021
Axonics receives FDA approval for third generation implantable neurostimulator
16 February 2021 - Axonics Modulation Technologies has received PMA supplement approval from the U.S. FDA for its third generation implantable ...
Posted by Michael Wonder on 17 Feb 2021
FDA approves first in the world, first-of-its-kind implant for the treatment of rare bone disease as a humanitarian use device
17 February 2021 - Today, the U.S. FDA approved the Patient Specific Talus Spacer 3D-printed talus implant for humanitarian use. ...
Posted by Michael Wonder on 16 Feb 2021
Novartis Entresto granted expanded indication in chronic heart failure by FDA
16 February 2021 - Entresto is the first and only therapy approved in the US to treat patients diagnosed with guideline-defined ...
Posted by Michael Wonder on 15 Feb 2021
Polaryx Therapeutics receives both rare paediatric disease and orphan drug designations for the treatment of Krabbe disease with PLX-300
10 February 2021 - Polaryx Therapeutics announced today that it has received both rare paediatric disease and orphan drug designations for ...
Posted by Michael Wonder on 14 Feb 2021
Assessment of FDA and EMA approved systemic oncology therapies and clinically meaningful improvements in quality of life
11 February 2021 - Are oncology therapies recently approved by the US FDA and the EMA associated with clinically meaningful improvements ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...