Blog
RSS FeedPosted by Michael Wonder on 23 Jul 2024
Johnson & Johnson seeks US FDA approval of Spravato (esketamine) as the first and only monotherapy for adults with treatment-resistant depression
22 July 2024 - Phase 4 Spravato monotherapy data shows rapid improvement in depressive symptoms at ~24 hours, sustained through at ...
Posted by Michael Wonder on 22 Jul 2024
Boehringer Ingelheim and GoodRx announce exclusive patient affordability initiative for adalimumab-adbm injection, Boehringer’s biosimilar to Humira
18 July 2024 - First biosimilar with an exclusive low cash price on the GoodRx platform. ...
Posted by Michael Wonder on 20 Jul 2024
Neuren receives rare paediatric disease designation from FDA
19 July 2024 - Neuren Pharmaceuticals has received rare paediatric disease designation from the US FDA for NNZ-2591 in Phelan-McDermid ...
Posted by Michael Wonder on 19 Jul 2024
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults
18 July 2024 - Voquenza met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid ...
Posted by Michael Wonder on 19 Jul 2024
Lexicon Pharmaceuticals receives 20 December 2024 PDUFA goal date for sotagliflozin type 1 diabetes NDA resubmission
16 July 2024 - Launch preparations actively underway; launch planned for early 2025. ...
Posted by Michael Wonder on 19 Jul 2024
Diamyd Medical receives second US FDA fast track designation for Diamyd - for the prevention of type 1 diabetes
18 July 2024 - Diamyd Medical announced today that the US FDA has granted fast track designation for Diamyd (rhGAD65/alum) to ...
Posted by Michael Wonder on 19 Jul 2024
Atara Biotherapeutics announces US FDA acceptance and priority review of the biologics license application for tabelecleucel for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease
17 July 2024 - PDUFA target action date of 15 January 2025. ...
Posted by Michael Wonder on 19 Jul 2024
Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose
16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 18 Jul 2024
Transparent and complete reporting of surrogate endpoints in trials: the SPIRIT-Surrogate and CONSORT-Surrogate extensions
11 July 2024 - Randomised trials are resource-intensive studies that provide robust evidence for evaluating the effectiveness of interventions. ...
Posted by Michael Wonder on 18 Jul 2024
Diakonos Oncology receives FDA fast track designation for pancreatic cancer dendritic cell vaccine
15 July 2024 - Diakonos Oncology announced today that the US FDA has granted fast track designation for the company’s unique ...
Posted by Michael Wonder on 18 Jul 2024
Sellas announces US FDA rare paediatric disease designation granted to SLS009 for the treatment of paediatric acute myeloid leukaemia
16 July 2024 - Opened enrollment for paediatric AML patients in on-going Phase 2 clinical trial. ...
Posted by Michael Wonder on 17 Jul 2024
Longeveron announces US FDA grants fast track designation for Lomecel-B for the treatment of mild Alzheimer’s disease
17 July 2024 - Second designation received for Lomecel-B for the treatment of mild Alzheimer’s disease after regenerative medicine advanced therapeutics ...
Posted by Michael Wonder on 16 Jul 2024
Arrivo announces FDA fast track designation for RABI-767 for patients with acute pancreatitis predicted to progress to severe disease
15 July 2024 - RABI-767 is a novel lipase inhibitor currently in a Phase 2a clinical trial. ...
Posted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...
Posted by Michael Wonder on 15 Jul 2024
Onco360 selected as a limited distribution specialty pharmacy partner for Rytelo (imetelstat)
12 July 2024 - Onco360 has been selected as a pharmacy partner by Geron Corporation for Rytelo (imetelstat) as a ...