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RSS FeedPosted by Michael Wonder on 31 Aug 2020
Mezzion shares tumble on FDA’s return of heart disease med NDA
31 August 2020 - Mezzion has announced it has received a complete response letter from the U.S. FDA over its submitted ...
Posted by Michael Wonder on 31 Aug 2020
FDA approves Xaracoll (bupivacaine hydrochloride) implant, a non-opioid, drug-device treatment option for acute post-surgical pain relief for up to 24 hours following open inguinal hernia repair in adults
31 August 2020 - Xaracoll is a first-of-its-kind, fully bioresorbable collagen implant that delivers bupivacaine hydrochloride directly to the surgical site ...
Posted by Michael Wonder on 31 Aug 2020
FDA releases draft guidance on PROs for device manufacturers
31 August 2020 - Device manufacturers have new draft guidance from the US FDA for the selection of patient-reported outcome ...
Posted by Michael Wonder on 31 Aug 2020
VelosBio announces FDA fast track and orphan drug designations for VLS-101 in patients with mantle cell lymphoma
31 August 2020 - VelosBio today announced that the U.S. FDA has granted the company fast track and orphan drug designation ...
Posted by Michael Wonder on 31 Aug 2020
CorMedix announces FDA acceptance for filing and priority review of new drug application for Defencath
31 August 2020 - FDA sets PDUFA goal date of 28 February 2021. ...
Posted by Michael Wonder on 31 Aug 2020
A quick virus test? Sure, if you can afford it.
31 August 2020 - Standard tests in New York City can take days or weeks. Wealthier people are turning to concierge ...
Posted by Michael Wonder on 30 Aug 2020
FDA head says he is willing to fast-track COVID-19 vaccine
30 August 2020 - Stephen Hahn insists he will not rush process just to help Donald Trump’s election chances. ...
Posted by Michael Wonder on 30 Aug 2020
FDA grants priority review of melflufen for patients with triple-class refractory multiple myeloma
29 August 2020 - Oncopeptides today announces that the US FDA has granted priority review for Oncopeptides' new drug application ...
Posted by Michael Wonder on 29 Aug 2020
FDA ousts spokeswoman after COVID therapy misstatements
29 August 2020 - Emily Miller joined the agency as chief spokeswoman this month. ...
Posted 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 ...