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RSS FeedPosted by Michael Wonder on 02 Sep 2021
FDA to hold Advisory Committee meeting to discuss Pfizer-BioNTech’s application for COVID-19 booster
2 September 2021 - Today, the U.S. FDA announced a virtual meeting of its Vaccines and Related Biological Products Advisory ...
Posted by Michael Wonder on 02 Sep 2021
Moderna announces submission of initial data to US FDA for its COVID-19 vaccine booster
1 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40x against the ...
Posted by Michael Wonder on 01 Sep 2021
Coherus and Junshi Biosciences announce completion of rolling BLA submission to U.S. FDA for toripalimab for the treatment of nasopharyngeal carcinoma
1 September 2021 - Junshi Biosciences and Coherus Biosciences announced today the completion of the rolling submission of the biologics ...
Posted by Michael Wonder on 01 Sep 2021
FDA approves zanubrutinib for Waldenström’s macroglobulinaemia
1 September 2021 - On 31 August 2021, the Food and Drug Administration approved zanubrutinib (Brukinsa, BeiGene) for adult patients with ...
Posted 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. ...