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RSS FeedPosted by Michael Wonder on 21 Feb 2024
FDA and EMA accept vorasidenib regulatory submissions for the treatment of IDH mutant diffuse glioma
20 February 2024 - In clinical studies, vorasidenib has demonstrated strong blood-brain barrier penetrance alongside clinically meaningful and statistically significant ...
Posted by Michael Wonder on 20 Feb 2024
Omnix Medical granted fast track designation by US FDA for its next generation anti-infective OMN6
20 February 2024 - Omnix Medical today announced that the Company has received fast track designation for its novel anti-infective ...
Posted by Michael Wonder on 20 Feb 2024
Medera’s Sardocor announces fast track designation and dosing of 3 patients in first in human HFpEF gene therapy trial
14 February 2024 - In the Phase 1/2A clinical trial for SRD-001, an adeno-associated virus mediated first in human gene therapy ...
Posted by Michael Wonder on 20 Feb 2024
Immuneering receives FDA fast track designation for IMM-1-104 in pancreatic cancer
20 February 2024 - Company expects multiple readouts from its Phase 1/2a clinical trial in 2024. ...
Posted by Michael Wonder on 20 Feb 2024
PepGen receives US FDA fast track designation for PGN-EDODM1 for the treatment of myotonic dystrophy type 1
20 February 2024 - PepGen today announced that the US FDA has granted fast track designation to PGN-EDODM1, an investigational candidate ...
Posted by Michael Wonder on 20 Feb 2024
Disc Medicine receives FDA fast track designation for DISC-0974 for the treatment of anaemia in non-dialysis dependent chronic kidney disease
20 February 2024 - Disc Medicine today announced that the US FDA has granted fast track designation to DISC-0974 for the ...
Posted by Michael Wonder on 20 Feb 2024
argenx announces FDA acceptance of supplemental biologics license application with priority review for Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy
20 February 2024 - Prescription Drug User Fee Act target action date is 21 June 2024. ...
Posted by Michael Wonder on 20 Feb 2024
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus chemotherapy as treatment for primary advanced or recurrent endometrial carcinoma
20 February 2024 - Acceptance based on results from the pivotal Phase 3 NRG-GY018 trial. ...
Posted by Michael Wonder on 20 Feb 2024
US FDA accepts supplemental new drug application for Krazati (adagrasib) in combination with cetuximab as a targeted treatment option for patients with previously treated KRAS G12C mutated locally advanced or metastatic colorectal cancer for priority review
20 February 2024 - BMS today announced that the US FDA has accepted for priority review the supplemental new drug ...
Posted by Michael Wonder on 19 Feb 2024
VivaGel BV US FDA appeal outcome
19 February 2024 - Starpharma today announces that it has completed the formal dispute resolution process with the US FDA in ...
Posted by Michael Wonder on 19 Feb 2024
Certa Therapeutics’ FT011 granted US FDA fast track for the treatment of systemic sclerosis
19 February 2024 - Certa Therapeutics today announces that the US FDA has granted fast track designation for its investigational therapy ...
Posted by Michael Wonder on 19 Feb 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated advanced non-squamous non-small cell lung cancer
19 February 2024 - Application based on results from the TROPION-Lung01 Phase 3 trial. ...
Posted by Michael Wonder on 18 Feb 2024
FDA approves first medication to help reduce allergic reactions to multiple foods after accidental exposure
16 February 2024 - Today, the US FDA approved Xolair (omalizumab) injection for immunoglobulin E-mediated food allergy in certain adults and ...
Posted by Michael Wonder on 18 Feb 2024
Sarepta Therapeutics announces US FDA acceptance of an efficacy supplement to expand the Elevidys indication
16 February 2024 - Priority review granted, with a review goal date of 21 June 2024. ...
Posted by Michael Wonder on 16 Feb 2024
FDA approves osimertinib with chemotherapy for EGFR mutated non-small-cell lung cancer
16 February 2024 - Today, the FDA approved osimertinib (Tagrisso, AstraZeneca) with platinum-based chemotherapy for patients with locally advanced or ...