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RSS FeedPosted by Michael Wonder on 27 Jun 2023
Allecra Therapeutics submits new drug application to the US FDA for Exblifep for the treatment of complicated urinary tract infections
27 June 2023 - Allecra Therapeutics announced today the submission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 27 Jun 2023
FDA issues complete response letter for aflibercept 8 mg biologics license application solely due to an on-going review of inspection findings at a third-party filler
27 June 2023 - No issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in ...
Posted by Michael Wonder on 27 Jun 2023
UCB provides update on US FDA review of the biologics license application for bimekizumab
26 June 2023 - UCB today announced that the biologics license application for bimekizumab for the treatment of adults with ...
Posted by Michael Wonder on 27 Jun 2023
FDA accepts Pfizer’s application for haemophilia B gene therapy fidanacogene elaparvovec
27 June 2023 - Submissions based on positive Phase 3 data from BENEGENE-2 trial. ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
Posted by Michael Wonder on 25 Jun 2023
Use of real world evidence in regulatory decision making – EMA publishes review of its studies
23 June 2023 - Real world evidence from studies led by regulators can complement evidence from other sources including clinical trials. ...
Posted by Michael Wonder on 24 Jun 2023
Pfizer and BioNTech submit applications to US FDA for Omicron XBB.1.5 adapted monovalent COVID-19 vaccine
23 June 2023 - The submissions reflect guidance from FDA and other major health authorities to provide COVID-19 vaccines better matched ...
Posted by Michael Wonder on 24 Jun 2023
Leo Pharma receives positive CHMP opinion for new Adtralza (tralokinumab) injection device
23 June 2023 - CHMP recommends approval of the Adtralza pre-filled pen. ...
Posted by Michael Wonder on 23 Jun 2023
Moderna files for FDA authorisation of its updated COVID-19 vaccine
22 June 2023 - Preliminary clinical data demonstrated a robust immune response by the company's XBB.1.5 monovalent vaccine against XBB descendent ...
Posted by Michael Wonder on 22 Jun 2023
Aldeyra Therapeutics provides regulatory update on ADX-2191
21 June 2023 - Based on US FDA determination of lack of adequate and well controlled investigations in the scientific literature, ...
Posted 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
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 ...