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RSS FeedPosted by Michael Wonder on 14 Feb 2021
Assessment of FDA and EMA approved systemic oncology therapies and clinically meaningful improvements in quality of life
11 February 2021 - Are oncology therapies recently approved by the US FDA and the EMA associated with clinically meaningful improvements ...
Posted by Michael Wonder on 14 Feb 2021
Mallinckrodt provides regulatory update on StrataGraft
12 February 2021 - Mallinckrodt today announced that the U.S. FDA has informed the Company that it is deferring action ...
Posted by Michael Wonder on 14 Feb 2021
FDA approves drug to reduce bone marrow suppression caused by chemotherapy
12 February 2021 - Today, the U.S. FDA approved Cosela (trilaciclib) as the first therapy in its class to reduce the ...
Posted by Michael Wonder on 14 Feb 2021
U.S. FDA approves Panzyga for the treatment of adults with chronic inflammatory demyelinating polyneuropathy
12 February 2021 - The first and only FDA approved intravenous immunoglobulin with two maintenance dosing options for chronic inflammatory ...
Posted by Michael Wonder on 12 Feb 2021
Rescindo Therapeutics’ RSC-57 receives FDA orphan drug designation and rare paediatric disease designation for Kabuki syndrome
12 February 2021 - Rescindo Therapeutics announced today that the U.S. FDA has granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 11 Feb 2021
BrainCool receives FDA breakthrough device designation for Cooral System for prevention of oral mucositis
11 February 2021 - Recent Medicare reimbursement ruling provides an additional boost in paving the way for elimination of one of ...
Posted by Michael Wonder on 11 Feb 2021
BrainQ gets FDA breakthrough status for its device for reducing disability following stroke
11 February 2021 - The breakthrough device designation, which comes after new trial data, is expected to expedite the device's path ...
Posted by Michael Wonder on 11 Feb 2021
Seagen and Genmab submit tisotumab vedotin biologics license application to the U.S. FDA for patients with recurrent or metastatic cervical cancer
11 February 2021 - Submission based on positive pivotal innovaTV 204 trial results presented at the European Society of Medical Oncology ...
Posted by Michael Wonder on 11 Feb 2021
Cerus Endovascular receives FDA breakthrough device designation for its Contour Neurovascular System
11 February 2021 - Cerus Endovascular today announced that it has received breakthrough device designation from the U.S. FDA for ...
Posted by Michael Wonder on 11 Feb 2021
FDA approves first in class Evkeeza (evinacumab-dgnb) for patients with ultra rare inherited form of high cholesterol
11 February 2021 - In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced ow-density lipoprotein cholesterol by nearly ...
Posted by Michael Wonder on 11 Feb 2021
FDA’s generic drug program in 2020 helped ensure availability of high quality, affordable drugs amid COVID-19
11 February 2021 - Generic drugs play a vital role in facilitating access to lifesaving medicines for Americans and remain a ...
Posted by Michael Wonder on 10 Feb 2021
Botox (onabotulinumtoxinA) receives FDA approval for paediatric detrusor overactivity associated with a neurologic condition
10 February 2021 - Milestone marks 12th U.S. therapeutic indication for Botox. ...
Posted by Michael Wonder on 10 Feb 2021
FDA authorises monoclonal antibodies for treatment of COVID-19
9 February 2021 - Today, the U.S. FDA issued an emergency use authorisation for bamlanivimab and etesevimab administered together for the ...
Posted by Michael Wonder on 09 Feb 2021
FDA approves Libtayo (cemiplimab-rwlc) as first immunotherapy indicated for patients with advanced basal cell carcinoma
9 February 2021 - Libtayo now approved for patients with advanced stages of the two most common skin cancers in the ...
Posted by Michael Wonder on 09 Feb 2021
Collaboration between the FDA and industry is essential to foster innovation in Alzheimer’s treatments
8 February 2021 - As the Food and Drug Administration moves closer to a decision about whether to approve a ...