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RSS FeedPosted 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 12 Feb 2021
EMA starts rolling review of CureVac’s COVID-19 vaccine (CVnCoV)
12 February 2021 - EMA’s human medicines committee (CHMP) has started a rolling review of CVnCoV, a COVID‑19 vaccine being ...
Posted by Michael Wonder on 11 Feb 2021
COVID-19 vaccine shipment could arrive in Australia as early as next week
11 February 2021 - Coronavirus vaccines are a step closer to arriving in Australia after the European Commission formally approved ...
Posted by Michael Wonder on 11 Feb 2021
CSL confident it can make vaccine to cover variants, if needed
11 February 2021 - CSL is confident it can make an updated version of AstraZeneca’s COVID-19 vaccine to cover any ...
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
European Union admits errors in coronavirus vaccine rollout, 'deeply regrets' decision on export curbs
10 February 2021 - European Commission President Ursula von der Leyen has acknowledged failings in the EU's approval and rollout ...
Posted by Michael Wonder on 10 Feb 2021
It will be six years before the world is vaccinated against COVID-19: experts
10 February 2021 - It will take six years to vaccinate enough of the world’s population to reduce the threat ...
Posted by Michael Wonder on 10 Feb 2021
Drug maker will slash prices on cancer medicines to end price gouging probe in Europe
10 February 2021 - After months of deliberation, the European Commission has accepted an offer from Aspen Pharma to reduce ...
Posted by Michael Wonder on 10 Feb 2021
EMA expected to approve Johnson & Johnson vaccine by March
10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...