Blog
RSS FeedPosted by Michael Wonder on 29 May 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma
29 May 2024 - Acceptance based on results from the pivotal Phase 3 CCTG IND.227/KEYNOTE-483 trial, which demonstrated a statistically significant ...
Posted by Michael Wonder on 28 May 2024
Fresenius announces FDA acceptance for review of denosumab biosimilar application
27 May 2024 - Fresenius announced today that the US FDA has accepted for review the company’s biologics license application ...
Posted by Michael Wonder on 28 May 2024
Sarclisa accepted for FDA priority review for the treatment of transplant-ineligible newly diagnosed multiple myeloma
27 May 2024 - FDA priority review granted based on positive results from IMROZ Phase 3 study. ...
Posted by Michael Wonder on 28 May 2024
Telix submits NDA for new prostate cancer imaging agent
27 May 2024 - Telix Pharmaceuticals today announces it has submitted a new drug application to the US FDA for ...
Posted by Michael Wonder on 25 May 2024
Verastem Oncology announces the initiation of a rolling submission of NDA to FDA seeking accelerated approval of avutometinib and defactinib combination for the treatment of adult patients with recurrent KRAS mutant low grade serous ovarian cancer
24 May 2024 - Plan to complete NDA submission with the mature RAMP 201 dataset, anticipated to include 12 months of ...
Posted by Michael Wonder on 23 May 2024
Jiangsu to ‘reapply for US approval of rivoceranib combo therapy ASAP’
23 May 2024 - Hangseo Hengrui Pharmaceuticals said Thursday that it would meet with the US FDA as soon as ...
Posted by Michael Wonder on 22 May 2024
Atara Biotherapeutics submits tabalecleucel (tab-cel) biologics license application for treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease with US FDA
20 May 2024 - First allogeneic T-cell therapy BLA submission to US FDA. ...
Posted by Michael Wonder on 22 May 2024
OWP Pharmaceuticals announces FDA filing acceptance for new drug application of Subvenite (lamotrigine) oral suspension
20 May 2024 - OWP announced today that it has received US FDA acceptance for the new drug application submission ...
Posted 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. ...