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RSS FeedPosted 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
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
ViiV Healthcare submits supplemental new drug application to US FDA for expanded use of Cabenuva (cabotegravir, rilpivirine) as an HIV treatment for use every 2 months
24 February 2021 - ViiV Healthcare announced today the submission of a supplemental new drug application to the US FDA for ...
Posted by Michael Wonder on 24 Feb 2021
Locate Bio’s Chondro3 granted FDA breakthrough device designation
24 February 2021 - The Company’s second FDA Breakthrough Device designation granted in 2021. ...
Posted by Michael Wonder on 24 Feb 2021
U.S. FDA accepts for priority review Pfizer's application for Ticovac (tick-borne encephalitis vaccine)
23 February 2021 - If approved, the vaccine may help reduce the risk of tick-borne encephalitis for people traveling to endemic ...
Posted by Michael Wonder on 24 Feb 2021
Inovise receives breakthrough device designation for novel non-invasive system to remotely monitor risk of decompensation in heart failure patients
23 February 2021 - Inovise Medical today announced the U.S. FDA has granted breakthrough device designation for its Audicor heart failure ...
Posted by Michael Wonder on 23 Feb 2021
FDA approves EndoClot Hemostat to manage GI bleeding
23 February 2021 - A unique product to rapidly and reliably control bleeding during GI procedures. ...
Posted by Michael Wonder on 23 Feb 2021
FDA to allow Pfizer-BioNTech vaccine to be stored at higher temperatures
24 February 2021 - The U.S. FDA plans to approve Pfizer Inc and BioNTech SE’s request to store their COVID-19 ...