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RSS FeedPosted by Michael Wonder on 01 Mar 2021
Vascular Graft Solutions wins FDA approval to Market the VIOLA clampless proximal anastomosis system for CABG
1 March 2021 - Vascular Grafts Solutions announced today receipt of marketing clearance from the FDA for the VIOLA, a new ...
Posted by Michael Wonder on 01 Mar 2021
US FDA accepts Merck’s gefapixant new drug application for review
1 March 2021 - Application for orally administered selective P2X3 receptor antagonist based on findings from two Phase 3 trials in ...
Posted by Michael Wonder on 01 Mar 2021
Avadel Pharmaceuticals announces FDA acceptance of new drug application for FT218 in adults with narcolepsy for the treatment of excessive daytime sleepiness and cataplexy
1 March 2021 - FT218 assigned PDUFA target action date of 15 October 2021. ...
Posted by Michael Wonder on 01 Mar 2021
CorMedix receives complete response letter from FDA for DefenCath catheter lock solution
1 March 2021 - CorMedix announced today that the US FDA cannot approve the new drug application for DefenCath (taurolidine/heparin catheter ...
Posted by Michael Wonder on 01 Mar 2021
Athenex receives FDA complete response letter for oral paclitaxel plus encequidar for the treatment of metastatic breast cancer
1 March 2021 - Athenex today announced that the U.S. FDA has issued a complete response letter for the company’s ...
Posted by Michael Wonder on 01 Mar 2021
Rare Disease Day 2021: FDA shows sustained support of rare disease product development during the public health emergency
1 March 2021 - Rare Disease Day is a time to reflect on both the progress that has been made, and ...
Posted by Michael Wonder on 01 Mar 2021
FDA authorises first robotically assisted surgical device for performing transvaginal hysterectomy
1 March 2021 - The U.S. FDA has authorised marketing of the Hominis Surgical System, a new robotically-assisted surgical device that ...
Posted by Michael Wonder on 01 Mar 2021
FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma
26 February 2021 - Today the FDA granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone ...
Posted by Michael Wonder on 01 Mar 2021
FDA allows more flexible storage, transportation conditions for Pfizer-BioNTech COVID-19 vaccine
25 February 2021 - Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution. ...
Posted by Michael Wonder on 01 Mar 2021
Johnson & Johnson COVID-19 vaccine authorised by U.S. FDA for emergency use - first single shot vaccine in fight against global pandemic
27 February 2021 - Johnson & Johnson today announced that the U.S. FDA has issued emergency use authorisation for its single-dose ...
Posted 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 26 Feb 2021
Retrotope granted rare paediatric disease designation from FDA for lead development candidate, RT001, in two life-threatening neurodegenerative indications
25 February 2021 - RT001 also granted fast track designation by FDA in Friedreich’s ataxia. ...
Posted by Michael Wonder on 25 Feb 2021
Allergan submits new drug application for investigational AGN-190584 for the treatment of presbyopia
25 February 2021 - If approved, this is expected to be the first eye drop to treat presbyopia. ...