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RSS FeedPosted by Michael Wonder on 06 Jan 2026
Alixorexton granted breakthrough therapy designation by US FDA for the treatment of narcolepsy type 1
6 January 2026 - Alkermes today announced that the US FDA has granted breakthrough therapy designation to alixorexton for the ...
Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for ...
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
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 01 Jan 2026
Outlook Therapeutics provides regulatory update on US FDA review of ONS-5010/Lytenava (bevacizumab-vikg) for the treatment of wet AMD (December 2025)
31 December 2025 - FDA issues complete response letter for resubmitted ONS-5010 BLA. ...
Posted by Michael Wonder on 01 Jan 2026
Axsome Therapeutics announces FDA acceptance and priority review of supplemental new drug application for AXS-05 for the treatment of Alzheimer’s disease agitation
31 December 2025 - FDA grants AXS-05 priority review designation and sets PDUFA action goal date of 30 April 2026. ...
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, ...