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RSS FeedPosted by Michael Wonder on 29 Aug 2020
FDA announces Advisory Committee meeting to discuss COVID-19 vaccines
28 August 2020 - The U.S. Food and Drug Administration announced that a public meeting of the Vaccines and Related Biological ...
Posted by Michael Wonder on 29 Aug 2020
FDA broadens emergency use authorisation for Veklury (remdesivir) to include all hospitalised patients for treatment of COVID-19
28 August 2020 - Today, as part of its ongoing efforts to fight COVID-19, the U.S. FDA broadened the scope of ...
Posted by Michael Wonder on 28 Aug 2020
U.S. FDA approves Cystadrops (0.37% cysteamine ophthalmic solution), a new practical treatment option for the ocular manifestations of cystinosis
25 August 2020 - Recordati Rare Diseases today announced the U.S. FDA has approved Cystadrops (0.37% cysteamine ophthalmic solution). ...
Posted by Michael Wonder on 28 Aug 2020
Taysha Gene Therapies receives orphan drug designation and rare paediatric disease designation for TSHA-101 for GM2 gangliosidosis
27 August 2020 - TSHA-101 anticipated to advance into the clinic by the end of 2020. ...
Posted by Michael Wonder on 28 Aug 2020
Rocket Pharmaceuticals receives FDA fast track designation for RP-L401 gene therapy for infantile malignant osteopetrosis
27 August 2020 - Rocket’s fifth gene therapy program receives fast track designation. ...
Posted by Michael Wonder on 27 Aug 2020
COVID-19 vaccines are getting closer. Should we be worried they've come so quickly?
27 August 2020 - Back in March, when the coronavirus pandemic was starting to sweep the globe, a vaccine couldn't ...
Posted by Michael Wonder on 27 Aug 2020
Trump has launched an all-out attack on the FDA. Will its scientific integrity survive?
27 August 2020 - President Trump has instigated an all-out crusade against the FDA at a critical point in the ...
Posted by Michael Wonder on 27 Aug 2020
This is a heart drug that the world doesn’t need
27 August 2020 - Twenty years ago, perhaps the hottest area of drug research was on a class of compounds called ...
Posted by Michael Wonder on 27 Aug 2020
FDA works to evaluate cancer therapies in patients with brain metastases
27 August 2020 - Today, the U.S. FDA issued a draft guidance document, “Evaluating Cancer Drugs in Patients with Central Nervous ...
Posted by Michael Wonder on 27 Aug 2020
Cassiopea receives FDA approval for Winlevi (1% clascoterone cream), first in class topical acne treatment targeting the androgen receptor
27 August 2020 - Cassiopea today announced that the United States FDA approved Winlevi (1% clascoterone cream) for the treatment of ...
Posted by Michael Wonder on 27 Aug 2020
KYE Pharmaceuticals and Catalyst Pharmaceuticals challenge Health Canada’s decision to overlook Firdapse data exclusivity
26 August 2020 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced the filing of a proceeding in Canadian Federal Court ...
Posted by Michael Wonder on 27 Aug 2020
Editas Medicine receives rare paediatric disease designation for EDIT-301 for the treatment of sickle cell disease
24 August 2020 - Editas Medicine today announced that the U.S. FDA has granted rare paediatric disease designation for EDIT-301, an ...
Posted by Michael Wonder on 27 Aug 2020
FDA approves Foundation Medicine's FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test with multiple companion diagnostic indications for patients with advanced cancer
26 August 2020 - FDA approval includes companion diagnostic claims for Rubraca (rucaparib), the first PARP inhibitor approved in a prostate ...
Posted by Michael Wonder on 27 Aug 2020
European Commission approves Blenrep (belantamab mafodotin) for the treatment of patients with relapsed and refractory multiple myeloma
26 August 2020 - Marketing authorisation follows the recent US approval of Blenrep. ...
Posted by Michael Wonder on 27 Aug 2020
The EU Commission grants conditional approval for Idefirix (imlifidase) in highly sensitised kidney transplant patients in the European Union
26 August 2020 - The conditional approval by the European Commission serves as a landmark milestone for Hansa Biopharma, as Idefirix ...