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RSS FeedPosted by Michael Wonder on 19 Dec 2025
Egetis Therapeutics initiates new drug application in the USA for Emcitate (tiratricol) for MCT8 deficiency
19 December 2025 - Egetis Therapeutics today announced that the Company has initiated a rolling new drug application submission to ...
Posted by Michael Wonder on 19 Dec 2025
Sangamo Therapeutics initiates rolling submission of BLA to US FDA for ST-920 in Fabry disease
18 December 2025 - Sangamo expects to complete biological license application submission under accelerated approval pathway in second quarter of ...
Posted by Michael Wonder on 18 Dec 2025
Novo Nordisk files for FDA approval of CagriSema, the first onceweekly combination of GLP‑1 and amylin analogues for weight management
18 December 2025 - – Today, Novo Nordisk announced the submission of a new drug application to the US FDA ...
Posted by Michael Wonder on 17 Dec 2025
Vanda announces submission of biologics license application to the FDA for imsidolimab for the treatment of generalised pustular psoriasis
15 December 2025 - Vanda Pharmaceuticals today announced the submission of a biologics license application to the US FDA) for ...
Posted by Michael Wonder on 16 Dec 2025
Aldeyra Therapeutics announces PDUFA extension of the new drug application of reproxalap for the treatment of dry eye disease
15 December 2025 - Aldeyra Therapeutics today announced that the US FDA has extended the PDUFA target action date for the ...
Posted by Michael Wonder on 16 Dec 2025
US FDA approves LIB Therapeutics’ Lerochol (lerodalcibep-liga) for adults with elevated LDL-cholesterol
15 December 2025 - Lerochol expected to be available in the US in spring 2026. ...
Posted by Michael Wonder on 15 Dec 2025
Sentynl Therapeutics announces FDA acceptance of CUTX-101 NDA resubmission
15 December 2025 - Sentynl Therapeutics today announced that the US FDA has accepted the resubmission of its new drug ...
Posted by Michael Wonder on 11 Dec 2025
Tris Pharma announces FDA acceptance of NDA for once nightly, low sodium oxybate product for narcolepsy and idiopathic hypersomnia
9 December 2025 - Tris Pharma today announced that the US FDA has accepted the company’s new drug application for TRN-257 ...
Posted by Michael Wonder on 11 Dec 2025
US FDA grants priority review to Bristol Myers Squibb's application for Opdivo (nivolumab) plus chemotherapy combination for classical Hodgkin's lymphoma
11 December 2025 - Bristol Myers Squibb today announced that the US FDA has accepted and granted priority review to ...
Posted by Michael Wonder on 08 Dec 2025
Agios provides update on US sNDA for mitapivat in thalassaemia
8 December 2025 - Agios Pharmaceuticals today announced that the US FDA has not yet issued a regulatory decision on the ...
Posted by Michael Wonder on 02 Dec 2025
Baxdrostat new drug application accepted under FDA priority review in the US for patients with hard to control hypertension
2 December 2025 - Submission based on positive BaxHTN Phase 3 trial results which demonstrated statistically significant and clinically meaningful reduction ...
Posted by Michael Wonder on 02 Dec 2025
MannKind announces US FDA accepts for review its supplemental new drug application of Furoscix ReadyFlow Auto-injector for the treatment of oedema in adults with chronic heart failure or chronic kidney disease
1 December 2025 - MannKind Corporation today announced that the US FDA has accepted the sNDA seeking approval for Furoscix ReadyFlow ...
Posted by Michael Wonder on 02 Dec 2025
Merck granted fast track designation by the US FDA for MK-2214 for the treatment of Alzheimer's disease
1 December 2025 - MK-2214, an investigational novel antibody targeting phosphorylated serine 413 (pS413) tau. ...
Posted by Michael Wonder on 01 Dec 2025
Vanda Pharmaceuticals provides regulatory update on tradipitant for motion sickness
28 November 2025 - Vanda Pharmaceuticals today announced updates regarding tradipitant for motion sickness. ...
Posted by Michael Wonder on 27 Nov 2025
US FDA grants priority review to sonrotoclax for the treatment of relapsed or refractory mantle cell lymphoma
26 November 2025 - BeOne Medicines today announced that the US FDA has accepted and granted priority review to a ...