Blog
RSS FeedPosted by Michael Wonder on 01 Dec 2024
Attruby (acoramidis), a near complete TTR stabiliser (≥90%), approved by FDA to reduce cardiovascular death and cardiovascular related hospitalisation in ATTR-CM patients
22 November 2024 - Attruby is the first and only approved product with a label specifying near complete stabilisation of TTR. ...
Posted by Michael Wonder on 30 Nov 2024
FDA approves updated drug labelling for fludarabine phosphate under Project Renewal
19 November 2024 - Today, the FDA approved updated drug labeling for fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz) under Project ...
Posted by Michael Wonder on 28 Nov 2024
US FDA approves FoundationOne Liquid CDx as a companion diagnostic for Tepmetko (tepotinib) to identify patients with MET exon 14 skipping alterations in non-small cell lung cancer
18 November 2024 - FoundationOne Liquid CDx is the first FDA approved companion diagnostic to identify patients who may be ...
Posted by Michael Wonder on 27 Nov 2024
UCB receives US FDA approval for Bimzelx (bimekizumab-bkzx) as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa
20 November 2024 - Approval is supported by data from the two Phase 3 studies, BE HEARD I and BE HEARD ...
Posted by Michael Wonder on 27 Nov 2024
Astellas provides update on Izervay (avacincaptad pegol intravitreal solution) supplemental new drug application
19 November 2024 - Astellas today announced the US FDA issued a complete response letter on 15 November 2024, regarding the ...
Posted by Michael Wonder on 17 Nov 2024
Azurity Pharmaceuticals announces FDA approval of Danziten (nilotinib) tablets, the first and only nilotinib with no mealtime restrictions
14 November 2024 - Azurity Pharmaceuticals announced today that the US FDA has approved Danziten, the first and only nilotinib with ...
Posted by Michael Wonder on 15 Nov 2024
FDA approves revumenib for relapsed or refractory acute leukaemia with a KMT2A translocation
15 November 2024 - Today, the FDA approved revumenib (Revuforj, Syndax Pharmaceuticals), a menin inhibitor, for relapsed or refractory acute ...
Posted by Michael Wonder on 14 Nov 2024
PTC Therapeutics announces FDA approval of AADC deficiency gene therapy
13 November 2024 - PTC Therapeutics announced today the US FDA accelerated approval of its gene therapy for the treatment of ...
Posted by Michael Wonder on 12 Nov 2024
Intercept receives complete response letter from FDA addressing Ocaliva supplemental new drug application
13 November 2024 - Intercept Pharmaceuticals today announced that the US FDA has issued a complete response letter that addresses ...
Posted by Michael Wonder on 09 Nov 2024
Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic test
6 November 2024 - MI Cancer Seek is the first and only simultaneous whole exome and whole transcriptome-based assay with ...
Posted by Michael Wonder on 08 Nov 2024
FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
8 November 2024 - Today, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus), a CD19 directed genetically modified autologous T cell ...
Posted by Michael Wonder on 06 Nov 2024
Satsuma Pharmaceuticals and SNBL resubmits the new drug application for STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura
30 October 2024 - Satsuma Pharmaceuticals and its corporate parent, Shin Nippon today announced the resubmission of the new drug ...
Posted by Michael Wonder on 06 Nov 2024
Journey Medical announces US FDA approval of Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for the treatment of rosacea
4 November 2024 - Journey Medical today announced that the FDA has approved Emrosi (minocycline hydrochloride extended release capsules, 40 ...
Posted by Michael Wonder on 03 Nov 2024
Protega Pharmaceuticals receives FDA approval for Roxybond (oxycodone hydrochloride) immediate release 10 mg tablet with abuse deterrent technology for management of pain
29 October 2024 - Patented SentryBond technology, a first of its kind abuse deterrent technology, is designed to provide multiple levels ...
Posted by Michael Wonder on 02 Nov 2024
Alvotech and Teva announce US FDA approval of additional presentation of Selarsdi (ustekinumab-aekn), expanding its label to include further indications approved for reference product, Stelara (ustekinumab)
22 October 2024 - Approval of Selarsdi 130 mg/26 mL in a single dose vial for intravenous infusion expands label to ...