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RSS FeedPosted by Michael Wonder on 22 Jun 2023
ARS Pharmaceuticals announces PDUFA date extension for neffy (intranasal epinephrine) for the treatment of allergic reactions (type 1), including anaphylaxis
20 June 2023 - Additional time needed for labelling and post-marketing requirements discussions; PDUFA date set for 19 September 2023. ...
Posted by Michael Wonder on 22 Jun 2023
Calliditas Therapeutics submits supplemental new drug application to US FDA for full approval of Tarpeyo
21 June 2023 - Calliditas Therapeutics today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 21 Jun 2023
FDA grants full approval for Blincyto (blinatumomab) to treat minimal residual disease positive B-cell precursor acute lymphoblastic leukaemia
21 June 2023 - Conversion from accelerated to full approval. ...
Posted by Michael Wonder on 21 Jun 2023
Teikoku Pharma granted FDA fast track designation for TPU-006, a novel 4 day dexmedetomidine transdermal system for post operative pain management
21 June 2023 - Teikoku Pharma today announced that the US FDA granted fast track designation for TPU-006 in managing post-operative ...
Posted by Michael Wonder on 21 Jun 2023
CorMedix announces FDA acceptance of resubmission of new drug application for DefenCath
21 June 2023 - CorMedix today announced that the resubmission of the new drug application for DefenCath has been accepted for ...
Posted by Michael Wonder on 21 Jun 2023
bluebird bio announces FDA priority review of the biologics license application for lovotibeglogene autotemcel (lovo-cel) for patients with sickle cell disease 12 years and older with a history of vaso-occlusive events
21 June 2023 - PDUFA date set for 20 December 2023. ...
Posted by Michael Wonder on 21 Jun 2023
Xbrance announce US FDA filing acceptance for a Lucentis (ranibizumab) biosimilar candidate
21 June 2023 - Xbrane Biopharma today announced the acceptance of the supplemental biologics license application for a Lucentis (ranibizumab) biosimilar ...
Posted by Michael Wonder on 21 Jun 2023
argenx announces US FDA approval of Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) injection for subcutaneous use in generalised myasthenia gravis
20 June 2023 - Efficacy of Vyvgart Hytrulo was established by demonstrating a comparable pharmacodynamic effect to Vyvgart in Phase 3 ...
Posted by Michael Wonder on 21 Jun 2023
Novo Nordisk takes actions to help protect US patients from unlawful sales of non-FDA approved medicines claiming to contain semaglutide
20 June 2023 - Initiating legal proceedings against medical spas, weight loss or wellness clinics, and compounding pharmacies to cease and ...
Posted by Michael Wonder on 20 Jun 2023
FDA approves talazoparib with enzalutamide for HRR gene mutated metastatic castration-resistant prostate cancer
20 June 2023 - Today, the FDA approved talazoparib (Talzenna, Pfizer) with enzalutamide for homologous recombination repair (HRR) gene mutated ...
Posted by Michael Wonder on 20 Jun 2023
FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers
20 June 2023 - Pilot geared toward sponsors of certain oncology drug products used with certainin vitro diagnostic tests ...
Posted by Michael Wonder on 20 Jun 2023
Evidence of lack of treatment efficacy derived from statistically non-significant results of randomised clinical trials
20 June 2023 - Many randomised clinical trials yield statistically non-significant results. Such results are difficult to interpret within the dominant ...
Posted by Michael Wonder on 20 Jun 2023
FDA approves new class of medicines to treat paediatric type 2 diabetes
20 June 2023 - Today, the US FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet ...
Posted by Michael Wonder on 20 Jun 2023
Geron announces submission of new drug application to FDA for first in class telomerase inhibitor imetelstat
20 June 2023 - Geron today announced the submission to the US FDA of a new drug application for imetelstat for ...
Posted by Michael Wonder on 20 Jun 2023
Precigen receives breakthrough therapy designation for PRGN-2012 AdenoVerse immunotherapy for the treatment of recurrent respiratory papillomatosis
20 June 2023 - Designation based on positive Phase 1 clinical data that showed 50% of patients were "surgery-free" (Complete ...