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RSS FeedPosted by Michael Wonder on 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...
Posted by Michael Wonder on 05 Jan 2026
Altimmune receives FDA breakthrough therapy designation for pemvidutide in MASH
5 January 2026 - Alignment on Phase 3 registrational trial parameters confirmed following receipt of minutes from end of phase 2 ...
Posted by Michael Wonder on 05 Jan 2026
Protara Therapeutics receives both FDA breakthrough therapy and fast track designations for TARA-002 in paediatric patients with lymphatic malformations
5 January 2026 - Protara Therapeutics today announced that the US FDA has granted both breakthrough therapy and fast track designations ...
Posted by Michael Wonder on 05 Jan 2026
MapLight Therapeutics receives fast track designation for ML-007C-MA for Alzheimer’s disease psychosis
5 January 2026 - MapLight Therapeutics today announced that the US FDA has granted fast track designation to ML-007C-MA, an investigational ...
Posted by Michael Wonder on 05 Jan 2026
Takeda and Protagonist announce submission of new drug application for rusfertide for treatment of polycythemia vera
5 January 2026 - NDA includes 52 week data from Phase 3 VERIFY study, which met the primary and all four ...
Posted by Michael Wonder on 05 Jan 2026
Sanofi’s Tzield accepted for priority review in the US for young children with stage 2 type 1 diabetes
5 January 2026 - The US FDA has accepted for priority review the supplemental biologic license application for Tzield (teplizumab-mzwv) to ...
Posted by Michael Wonder on 02 Jan 2026
Savara resubmits the biologics license application to the US FDA for Molbreevi for the potential treatment of auto-immune pulmonary alveolar proteinosis
22 December 2025 - Savara announced today that it has resubmitted the Molbreevi BLA to the FDA, with Fujifilm as ...
Posted by Michael Wonder on 01 Jan 2026
Corcept receives complete response letter for relacorilant as a treatment for patients with hypercortisolism
31 December 2025 - Corcept Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 31 Dec 2025
Cogent Biosciences announces submission of new drug application for bezuclastinib in non-advanced systemic mastocytosis
30 December 2025 - Cogent Biosciences today announced it has submitted its new drug application to the US FDA for ...
Posted by Michael Wonder on 31 Dec 2025
Ultragenyx completes rolling submission of biologics license application to US FDA for DTX401 AAV gene therapy for glycogen storage disease type Ia
30 December 2025 - If approved, DTX401 will be the first therapy approved to treat the underlying cause of glycogen storage ...
Posted by Michael Wonder on 31 Dec 2025
Vanda Pharmaceuticals announces FDA approval of Nereus (tradipitant) for the prevention of vomiting induced by motion: a historic scientific milestone in the prevention of motion sickness
30 December 2025 - Vanda Pharmaceuticals today announced that the US FDA has approved Nereus (tradipitant), an oral neurokinin-1 receptor antagonist, ...
Posted by Michael Wonder on 30 Dec 2025
FDA accepts for review Inovio's BLA for INO-3107 for the treatment of adults with recurrent respiratory papillomatosis
29 December 2025 - Inovio today announced that the US FDA accepted the company's biologics license application for INO-3107 for ...
Posted by Michael Wonder on 30 Dec 2025
Unicycive Therapeutics announces resubmission of new drug application for oxylanthanum carbonate
29 December 2025 - New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission. ...
Posted by Michael Wonder on 29 Dec 2025
Praxis Precision Medicines announces the FDA has granted breakthrough therapy designation for ulixacaltamide hydrochloride in essential tremor
29 December 2025 - The breakthrough therapy designation was granted based on the positive top-line results from the Essential3 Phase 3 ...
Posted by Michael Wonder on 29 Dec 2025
US FDA approves Agios’ Aqvesme (mitapivat) for the treatment of anaemia in adults with alfa or beta-thalassaemia
23 December 2025 - Aqvesme expected to be available in late January 2026, following Aqvesme REMS program implementation. ...