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RSS FeedPosted by Michael Wonder on 08 Apr 2024
ARS Pharmaceuticals submits response to FDA complete response letter for neffy (epinephrine nasal spray)
3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
Posted by Michael Wonder on 08 Apr 2024
Clinical benefit and regulatory outcomes of cancer drugs receiving accelerated approval
7 April 2024 - In this cohort study of cancer drugs granted accelerated approval from 2013 to 2017, 41% (19/46) did ...
Posted by Michael Wonder on 07 Apr 2024
FDA grants breakthrough therapy designation to sunvozertinib for the first-line treatment of patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations
7 April 2024 - Dizal today announced that the US FDA has granted breakthrough therapy designation to its sunvozertinib as ...
Posted by Michael Wonder on 05 Apr 2024
FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2 positive solid tumours
5 April 2024 - Today, the FDA granted accelerated approval to fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with ...
Posted by Michael Wonder on 04 Apr 2024
Amylyx Pharmaceuticals announces formal intention to remove Relyvrio/Albrioza from the market
4 April 2024 - Based on top-line results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started ...
Posted by Michael Wonder on 04 Apr 2024
FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...
Posted by Michael Wonder on 04 Apr 2024
Vanda Pharmaceuticals' Fanapt (iloperidone) receives US FDA approval for the acute treatment of bipolar I disorder
2 April 2024 - Fanapt treatment is now available to adult patients for the acute treatment of manic or mixed episodes ...
Posted by Michael Wonder on 03 Apr 2024
FDA approves new antibiotic for three different uses
3 April 2024 - Today, the US FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with ...
Posted by Michael Wonder on 03 Apr 2024
RemeGen's telitacicept (RC18) granted fast track designation by US FDA for treatment of primary Sjögren's syndrome
2 April 2024 - RemeGen has obtained fast track designation by the US FDA recently for its innovative BLyS/APRIL dual-target ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 02 Apr 2024
TME Pharma receives US FDA fast track designation for lead asset NOX-A12 in brain cancer
2 April 2024 - Fast track designation for NOX-A12 follows recently announced FDA clearance of investigational new drug application for Phase ...
Posted by Michael Wonder on 02 Apr 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
Posted by Michael Wonder on 01 Apr 2024
Voydeya approved in the US as add-on therapy to ravulizumab or eculizumab for treatment of extravascular haemolysis in adults with the rare disease PNH
1 April 2024 - Approval of first in class, oral, Factor D inhibitor based on results from pivotal ALPHA Phase ...
Posted by Michael Wonder on 01 Apr 2024
Eisai completes submission of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA
1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...
Posted by Michael Wonder on 01 Apr 2024
US FDA accepts Astellas’ supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
1 April 2024 - Target action date set for 19 November 2024. ...