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RSS FeedPosted by Michael Wonder on 01 Sep 2021
In2Bones receives FDA clearance for pre-surgery OrthoPlanify patient specific planning software and 3D printed cutting guides for Quantum Total Ankle System
1 September 2021 - In2Bones Global today announces the FDA clearance of OrthoPlanify patient-specific planning software and 3D printed cutting ...
Posted by Michael Wonder on 01 Sep 2021
Intelivation Technologies received FDA approval for the Golden Isles Pedicle Screw System
1 September 2021 - Intelivation Technologies announced today that they have achieved FDA 510(k) Clearance of the Golden Isles Pedicle ...
Posted by Michael Wonder on 01 Sep 2021
FDA requires warnings about increased risk of serious heart related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
1 September 2021 - Based on a completed U.S. FDA review of a large randomised safety clinical trial, we have concluded ...
Posted by Michael Wonder on 01 Sep 2021
FDA approves drug for schizophrenia to be administered at a six month interval
1 September 2021 - The FDA has approved Invega Hafyera (paliperidone palmitate) extended-release injectable suspension to treat schizophrenia in certain ...
Posted by Michael Wonder on 01 Sep 2021
U.S. FDA grants breakthrough device designation for innovative EndoSound vision ultrasound system
1 September 2021 - Endosound announced today that its EndoSound Vision System received a Breakthrough Device Designation from the U.S. FDA. ...
Posted by Michael Wonder on 01 Sep 2021
MicroTransponder receives FDA approval for breakthrough device benefiting stroke survivors
31 August 2021 - MicroTransponder today announced US FDA premarket approval of the Vivistim Paired VNS System, which significantly improves the ...
Posted by Michael Wonder on 31 Aug 2021
Real world outcomes associated with new cancer medicines approved by the FDA and EMA: a retrospective cohort study
August 2021 - Real world data studies are increasingly used to support regulatory approvals, reimbursement decisions, and changes in clinical practice ...
Posted by Michael Wonder on 31 Aug 2021
Teva and MedinCell announce FDA acceptance of new drug application for TV-46000/mdc-IRM as a treatment for patients with schizophrenia
31 August 2021 - File acceptance marks important milestone for Teva’s commitment to treatments for mental disorders ...
Posted by Michael Wonder on 31 Aug 2021
FDA approves updated indication for Merck’s Keytruda (pembrolizumab) for treatment of certain patients with urothelial carcinoma (bladder cancer)
31 August 2021 - Keytruda approved for treatment of patients with locally advanced or metastatic urothelial carcinoma who are Not ...
Posted by Michael Wonder on 31 Aug 2021
ANI Pharmaceuticals announces FDA acceptance of purified Cortrophin gel supplemental new drug application for multiple indications including multiple sclerosis, rheumatoid arthritis and nephrotic syndrome
31 August 2021 - Prescription Drug User Fee Act target action date is 29 October 2021. ...
Posted by Michael Wonder on 30 Aug 2021
Zimmer Biomet and Canary Medical announce FDA de novo classification grant and authorisation to market the world's first and only smart knee implant
30 August 2021 - Post-operative gait metrics to provide real world, objective patient data. ...
Posted by Michael Wonder on 30 Aug 2021
UCB announces Briviact (brivaracetam) now FDA approved to treat partial-onset seizures in paediatric patients one month of age and older
30 August 2021 - Tablets, oral solution and intravenous dosage forms of Briviact (brivaracetam) now FDA approved as both monotherapy or ...
Posted by Michael Wonder on 30 Aug 2021
FDA grants breakthrough device designation for ImpediMed's SOZO digital health platform for renal failure
30 August 2021 - FDA recognises potential of SOZO digital health platform to assist clinicians in measuring exact fluid volume of ...
Posted by Michael Wonder on 30 Aug 2021
FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis
30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease. ...
Posted by Michael Wonder on 28 Aug 2021
Genentech provides update on Tecentriq U.S. indication for PD-L1 positive, metastatic triple negative breast cancer
27 August 2021 - Genentech today announced that the company has made the decision to voluntarily withdraw the U.S. accelerated approval ...