Blog
RSS FeedPosted by Michael Wonder on 26 May 2021
FDA announces draft guidances to help increase transparency, assist reporting and timely completion for certain medical device studies after FDA approval or clearance
26 May 2021 - Today, the U.S. FDA issued two guidances regarding the surveillance of certain medical devices. ...
Posted by Michael Wonder on 26 May 2021
Medical device regulation comes into application
26 May 2021 - The medical device regulation, which was adopted in April 2017, changes the European legal framework for medical ...
Posted by Michael Wonder on 26 May 2021
Woebot Health receives FDA breakthrough device designation for post partum depression treatment
26 May 2021 - WB001 is the first digital therapeutic designed to reduce the burden of post partum depression. ...
Posted by Michael Wonder on 26 May 2021
Varian receives FDA breakthrough device designation for its cardiac radioablation system for treatment of refractory ventricular tachycardia
26 May 2021 - Varian's CRA system has been designated a "breakthrough device" by the FDA because of its potential to ...
Posted by Michael Wonder on 26 May 2021
Myovant Sciences and Pfizer receive FDA approval for Myfembree, the first once daily treatment for heavy menstrual bleeding associated with uterine fibroids
26 May 2021 - Myovant and Pfizer will jointly commercialise Myfembree with product availability expected in June. ...
Posted by Michael Wonder on 26 May 2021
Unity HA awarded breakthrough device designation for implantable neurostimulation technology to treat cluster headache pain
25 May 2021 - Unity HA announced today that the U.S. FDA has granted breakthrough device designation to the Pulsante SPG ...
Posted by Michael Wonder on 26 May 2021
Illuminare-1, a novel nerve visualisation investigational fluorophore, granted fast track designation by U.S. FDA
25 May 2021 - Illuminare Biotechnologies announced that its novel nerve imaging agent, Illuminare-1, has been granted fast track designation by ...
Posted by Michael Wonder on 25 May 2021
Adjusting for non-adherence or stopping treatments in randomised clinical trials
25 May 2021 - Randomised clinical trials allocate individuals to different treatments, or, more generally, to interventions and comparators, to determine ...
Posted by Michael Wonder on 25 May 2021
Spinal Stabilization Technologies earns FDA breakthrough designation for PerQdisc nucleus replacement system for degenerative disc disease
25 May 2021 - Spinal Stabilization Technologies announced today that it has earned the CE Mark and the FDA's breakthrough ...
Posted by Michael Wonder on 25 May 2021
President Biden still hasn’t appointed a permanent FDA commissioner. That has big implications for upcoming drug approvals.
25 May 2021 - Within the next few weeks, the FDA is set to make an extraordinary decision: whether or not ...
Posted by Michael Wonder on 25 May 2021
TherapeuticsMD announces submission of low dose Bijuva 0.5 mg/100 mg supplemental new drug application to FDA
25 May 2021 - TherapeuticsMD announced today that the Company submitted a supplemental new drug application for BIJUVA (oestradiol and ...
Posted by Michael Wonder on 25 May 2021
AbbVie receives European Commission approval of Venclyxto (venetoclax) in combination with a hypomethylating agent for patients with newly diagnosed acute myeloid leukaemia who are ineligible for intensive chemotherapy
25 May 2021 - Venclyxto (venetoclax) in combination with a hypomethylating agent is a new regimen approved by the European ...
Posted by Michael Wonder on 25 May 2021
TG Therapeutics announces FDA acceptance of biologics license application for ublituximab in combination with Ukoniq (umbralisib) as a treatment for patients with chronic lymphocytic leukaemia and small lymphocytic lymphoma
25 May 2021 - Prescription Drug User Fee Act goal date of 25 March 2022. ...
Posted by Michael Wonder on 25 May 2021
Merck receives positive EU CHMP opinion for Keytruda (pembrolizumab) in combination with chemotherapy as first-line treatment for certain patients with oesophageal cancer or HER2 negative gastro-oesophageal junction adenocarcinoma
24 May 2021 - Recommendation based on significant survival benefit demonstrated with Keytruda plus chemotherapy versus chemotherapy in Phase 3 KEYNOTE-590 ...
Posted by Michael Wonder on 25 May 2021
Scholar Rock receives fast track designation from the U.S. FDA for apitegromab for the treatment of patients with spinal muscular atrophy
24 May 2021 - Builds on Priority Medicines (PRIME) designation recently granted by the EMA recognising the unmet medical needs of ...