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RSS FeedPosted by Michael Wonder on 18 Mar 2026
Aldeyra Therapeutics receives complete response letter from the US Food and Drug Administration for the reproxalap new drug application for the treatment of signs and symptoms of dry eye disease
17 March 2026 - Aldeyra Therapeutics today announced receipt of a complete response letter from the US FDA for the new ...
Posted by Michael Wonder on 17 Mar 2026
Polaryx Therapeutics receives FDA fast track designation for PLX‑200 for late‑infantile neuronal ceroid lipofuscinosis
17 March 2026 - Regulatory milestone supports advancement of the SOTERIA Phase 2 basket trial evaluating PLX‑200 across multiple lysosomal storage ...
Posted by Michael Wonder on 17 Mar 2026
Sun Pharma announces US FDA acceptance of supplemental biologics license application for Ilumya (tildrakizumab-asmn) for the treatment of adults with active psoriatic arthritis
16 March 2026 - Sun Pharmaceutical Industries announced that the US FDA has accepted for review the supplemental biologics license ...
Posted by Michael Wonder on 17 Mar 2026
Argo Biopharma receives FDA fast track designation for BW-20805, an investigational siRNA therapy for the treatment of HAE
16 March 2026 - Global Phase 2 open-label study in adult hereditary angioedema patients on-going, company on track for primary completion ...
Posted by Michael Wonder on 16 Mar 2026
Cogent Biosciences announces FDA acceptance of new drug application for bezuclastinib in patients with non-advanced systemic mastocytosis
16 March 2026 - NDA based on positive clinical results from the SUMMIT pivotal trial in which bezuclastinib demonstrated clear clinical ...
Posted by Michael Wonder on 16 Mar 2026
Telix resubmits NDA to US FDA for TLX101-Px (Pixclara) brain cancer imaging candidate
16 March 2026 - Telix Pharmaceuticals today announces the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 13 Mar 2026
Novartis Cosentyx receives FDA approval for paediatric patients aged 12+ with moderate to severe hidradenitis suppurativa
13 March 2026 - Novartis announced today that Cosentyx (secukinumab) received US FDA approval for treating paediatric patients 12 years ...
Posted by Michael Wonder on 13 Mar 2026
GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk
13 March 2026 - GSK today announced that the US FDA has expanded the approved age indication of Arexvy (respiratory syncytial ...
Posted by Michael Wonder on 12 Mar 2026
ARTHEx Biotech granted FDA fast track designation for ATX-01 for the treatment of myotonic dystrophy type 1
11 March 2026 - ARTHEx Biotech today announced that the US FDA has granted fast track designation to ATX-01 for the ...
Posted by Michael Wonder on 12 Mar 2026
Quoin Pharmaceuticals announces FDA grants fast track designation for QRX003 for the treatment of Netherton syndrome
11 March 2026 - Quoin Pharmaceuticals today announced that the US FDA has granted fast track designation to QRX003 lotion (4%) ...
Posted by Michael Wonder on 11 Mar 2026
Capricor Therapeutics announces establishment of new PDUFA date for deramiocel BLA
10 March 2026 - Capricor Therapeutics today announced that the US FDA has lifted the previously issued complete response letter ...
Posted by Michael Wonder on 11 Mar 2026
Lenz Therapeutics announces submission of marketing authorisation application to the EMA for Vizz for the treatment of presbyopia
10 March 2026 - Lenz Therapeutics today announced that it has submitted a marketing authorisation application to the EMA for ...
Posted by Michael Wonder on 10 Mar 2026
Redx’s RXC008 granted US FDA fast track designation for fibrostenotic Crohn’s disease
10 March 2026 - Redx Pharma announces that the US FDA has granted fast track designation to RXC008, a GI ...
Posted by Michael Wonder on 10 Mar 2026
FDA approves first treatment for patients with cerebral folate transport deficiency
10 March 2026 - The US FDA today approved expanded use of Wellcovorin (leucovorin calcium) tablets for the treatment of ...
Posted by Michael Wonder on 10 Mar 2026
Sangamo Therapeutics advances rolling submission of BLA to US FDA for ST-920 in Fabry disease
9 March 2026 - Sangamo Therapeutics today announced advancement of the rolling submission of a BLA to the FDA seeking ...