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RSS FeedPosted by Michael Wonder on 26 Feb 2021
Empirical Spine initiates PMA submission process for FDA approval of Limiflex for degenerative spondylolisthesis
25 February 2021 - The LimiFlex Paraspinous Tension Band is a new, investigational device designed as an alternative to spinal fusion ...
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. ...
Posted by Michael Wonder on 25 Feb 2021
Exelixis announces breakthrough therapy designation granted to cabozantinib for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer
25 February 2021 - Exelixis expects to submit supplementary New Drug Application in 2021. ...
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
Adapting COVID-19 vaccines to SARS-CoV-2 variants: guidance for vaccine manufacturers
25 February 2021 - EMA has issued guidance outlining the requirements for manufacturers planning to modify their COVID-19 vaccines in ...
Posted by Michael Wonder on 25 Feb 2021
International cooperation to align approaches for regulation of COVID-19 vaccines and medicines
25 February 2021 - Regulators around the globe are committed to aligning their regulatory requirements and addressing knowledge gaps to facilitate ...
Posted by Michael Wonder on 25 Feb 2021
Three steps can help companies speed FDA approval of new drugs
24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...
Posted by Michael Wonder on 25 Feb 2021
Veru submits new drug application for proprietary Tadfin for benign prostatic hyperplasia
23 February 2021 - FDA PDUFA date is expected in December 2021. ...
Posted by Michael Wonder on 25 Feb 2021
Teleflex announces submission of biologics license application for its investigational freeze dried plasma
24 February 2021 - Submission is eligible for priority review and accelerated approval. ...
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 25 Feb 2021
Dascena announces FDA breakthrough device designation granted to machine learning diagnostic method
24 February 2021 - Algorithm for earlier detection of gastro-intestinal bleeding. ...
Posted by Michael Wonder on 25 Feb 2021
Kura Oncology receives FDA breakthrough therapy designation for tipifarnib in head and neck squamous cell carcinoma
24 February 2021 - Kura Oncology today announced that its investigational drug, tipifarnib, has been granted breakthrough therapy designation by the ...
Posted by Michael Wonder on 24 Feb 2021
Biden to sign order seeking homegrown fixes for shortfalls of foreign-made items
24 February 2021 - Shortages of medical supplies and ingredients for pharmaceuticals came into stark focus during the early days ...
Posted by Michael Wonder on 24 Feb 2021
Bladder cancer drug shortage resolved with Health Canada approval
24 February 2021 - Verity-BCG bladder cancer treatment available for Canadian patients in the spring. ...