Blog
RSS FeedPosted by Michael Wonder on 11 Jan 2026
Aquestive Therapeutics announces regulatory development for Anaphylm (dibutepinephrine) sublingual film
9 January 2026 - Announces receipt of FDA letter stating it has identified deficiencies that preclude labeling discussions for Anaphylm at ...
Posted by Michael Wonder on 11 Jan 2026
Camurus announces FDA acceptance of NDA resubmission for Oclaiz for the treatment of acromegaly
9 January 2026 - Camurus today announced that the US FDA has accepted for review the company's resubmission of the new ...
Posted by Michael Wonder on 08 Jan 2026
Vanda Pharmaceuticals announces receipt of FDA decision letter on Hetlioz supplemental new drug application for jet lag disorder
8 January 2026 - Vanda Pharmaceuticals today announced that it has received a decision letter from the US FDA's Center for ...
Posted by Michael Wonder on 08 Jan 2026
FDA approves new 2 gram presentation of Fibryga, enhancing convenience and precision in treating acquired fibrinogen deficiency
7 January 2026 - Octapharma today announced that the US FDA has approved a new 2 g presentation of Fibryga, fibrinogen ...
Posted by Michael Wonder on 08 Jan 2026
Vera Therapeutics announces US FDA granted priority review to biologics license application for atacicept for treatment of adults with IgA nephropathy
7 January 2026 - Vera Therapeutics today announced the atacicept biologics license application for the treatment of adults with immunoglobulin A ...
Posted by Michael Wonder on 07 Jan 2026
Biosplice announces the submission of its new drug application to the FDA for lorecivivint to treat knee osteoarthritis
6 January 2026 - Biosplice Therapeutics announced today that it has submitted its new drug application to the FDA for approval ...
Posted 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
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 ...