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RSS FeedPosted by Michael Wonder on 01 Sep 2020
FDA approves weekly therapy for adult growth hormone deficiency
1 September 2020 - On 28 August 2020, the U.S. FDA approved Sogroya (somapacitan) for adults with growth hormone deficiency. ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves Onureg (azacitidine tablets) for acute myeloid leukaemia
1 September 2020 - Today, the FDA approved azacitidine tablets (Onureg, Celgene) for continued treatment of patients with acute myeloid ...
Posted by Michael Wonder on 01 Sep 2020
FDA accepts Vertex’s supplemental new drug applications for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for additional CFTR mutations
1 September 2020 - More than 600 people with certain rare cystic fibrosis mutations could become newly eligible for Trikafta, Symdeko ...
Posted by Michael Wonder on 01 Sep 2020
Roche receives FDA approval for first HIV-1/HIV-2 Qualitative Test on the cobas 6800/8800 Systems in the fight against HIV/AIDS
1 September 2020 - Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management ...
Posted by Michael Wonder on 01 Sep 2020
Athenex announces FDA acceptance for filing of U.S. NDA for oral paclitaxel and encequidar in metastatic breast cancer with priority review
1 September 2020 - FDA grants priority review and sets PDUFA target action date of 28 February 2021. ...
Posted by Michael Wonder on 01 Sep 2020
Imfinzi approved in the EU for the treatment of extensive-stage small cell lung cancer
1 September 2020 - Only PD-1/PD-L1 immunotherapy to demonstrate a significant survival benefit and improved response rate in combination with a ...
Posted by Michael Wonder on 01 Sep 2020
Coronavirus vaccine before election unlikely — Dr. Gottlieb on FDA chief’s possible fast track
31 August 2020 - The former FDA commissioner said the more effective the vaccine is, and the more serious the U.S. ...
Posted by Michael Wonder on 01 Sep 2020
Canada secures deals for up to 114 million doses of potential COVID-19 vaccines from U.S. drug companies
31 August 2020 - Potential vaccine could be available by spring of next year. ...
Posted by Michael Wonder on 01 Sep 2020
Health Canada authorises Enspryng for Canadians living with neuromyelitis optica spectrum disorder
31 August 2020 - Roche Canada announced today that Health Canada has granted market authorisation for Enspryng (satralizumab) as monotherapy ...
Posted by Michael Wonder on 01 Sep 2020
FDA approves first-of-its-kind automated insulin delivery and monitoring system for use in young paediatric patients
31 August 2020 - Today, the U.S. FDA approved the MiniMed 770G System, a hybrid closed loop diabetes management device that ...
Posted 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. ...