Blog
RSS FeedPosted by Michael Wonder on 22 May 2024
Durect Corporation receives FDA breakthrough therapy designation for larsucosterol in alcohol-associated hepatitis
21 May 2024 - Durect plans to confirm the efficacy and safety of larsucosterol in a registrational Phase 3 clinical ...
Posted by Michael Wonder on 21 May 2024
Bristol Myers Squibb announces updated action date by the US FDA for subcutaneous nivolumab (nivolumab and hyaluronidase)
21 May 2024 - Updated PDUFA goal date of 29 December 2024. ...
Posted by Michael Wonder on 16 May 2024
Axogen initiates rolling submission of biologics license application to US FDA for Avance Nerve Graft
16 May 2024 - Axogen is pleased to announce that it has initiated the rolling submission process with the US FDA ...
Posted by Michael Wonder on 15 May 2024
Dynavax provides regulatory update on sBLA for four dose Heplisav-B regimen for adults on haemodialysis in the US
14 May 2024 - Dynavax Technologies today provided a regulatory update for the Company's supplemental biologics license application to include ...
Posted by Michael Wonder on 15 May 2024
Ascendis Pharma announces extension of US FDA review period for TransCon PTH for adults with hypoparathyroidism
14 May 2024 - PDUFA goal date extended by three months for further review of submission to 14 August 2024. ...
Posted by Michael Wonder on 15 May 2024
Eisai initiates rolling biologics license application to US FDA for Leqembi (lecanemab-irmb) for subcutaneous maintenance dosing
15 May 2024 - BioArctic's partner Eisai announced today that they have initiated the rolling submission of a biologics license application ...
Posted by Michael Wonder on 15 May 2024
PTC Therapeutics announces FDA acceptance and priority review of the BLA for Upstaza
14 May 2024 - PDUFA target action date of 13 November 2024. ...
Posted by Michael Wonder on 14 May 2024
Sumitomo Pharma announces FDA acceptance of supplemental new drug application for vibegron in men with overactive bladder symptoms receiving pharmacological therapy for benign prostatic hyperplasia
13 May 2024 - Supplemental new drug application submission based on Phase 3 study of vibegron 75 mg (Gemtesa) demonstrating statistically ...
Posted by Michael Wonder on 13 May 2024
Dupixent (dupilumab) sBLA accepted for FDA priority review for treatment of adolescents with chronic rhinosinusitis with nasal polyposis
13 May 2024 - If approved, Dupixent would be the first treatment in the US indicated for adolescents aged 12-17 years ...
Posted by Michael Wonder on 12 May 2024
Moderna announces update on investigational RSV vaccine
10 May 2024 - US FDA has informed Moderna that due to administrative constraints, the agency will not complete its review ...
Posted by Michael Wonder on 06 May 2024
Merus announces US FDA acceptance and priority review of biologics license application for zenocutuzumab for the treatment of NRG1 positive NSCLC and PDAC
6 May 2024 - If approved, zenocutuzumab will be the first targeted therapy for NRG1 positive cancer. ...
Posted by Michael Wonder on 06 May 2024
US FDA accepts Bristol Myers Squibb’s application for subcutaneous nivolumab (nivolumab and hyaluronidase)
6 May 2024 - Application based on results from CheckMate-67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab ...
Posted by Michael Wonder on 02 May 2024
Neurocrine Biosciences announces US FDA approval of Ingrezza Sprinkle (valbenazine) capsules
30 April 2024 - Neurocrine Biosciences today announced the US FDA has approved Ingrezza Sprinkle (valbenazine) capsules, a new oral ...
Posted by Michael Wonder on 01 May 2024
Iterum Therapeutics resubmits new drug application to US FDA for oral sulopenem
29 April 2024 - Potential approval early Q4, 2024. ...
Posted by Michael Wonder on 01 May 2024
Bavarian Nordic initiates rolling submission of biologics license application with FDA for its Chikungunya vaccine candidate
29 April 2024 - Bavarian Nordic today announced that it has initiated the rolling submission process with the US FDA ...