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RSS FeedPosted by Michael Wonder on 24 Sep 2025
Biogen provides regulatory update on high dose regimen of nusinersen
23 September 2023 - Biogen today announced that the US FDA issued a complete response letter for the Company’s supplemental ...
Posted by Michael Wonder on 24 Sep 2025
Enhertu plus pertuzumab granted priority review in the US as first-line treatment for patients with HER2 positive metastatic breast cancer
24 September 2025 - Based on DESTINY-Breast09 Phase 3 trial results, which showed Enhertu plus pertuzumab reduced the risk of ...
Posted by Michael Wonder on 23 Sep 2025
Lexicon Pharmaceuticals announces update on submission of additional data to US FDA supporting the benefit-risk profile of Zynquista in type 1 diabetes
23 September 2025 - Data obtained from ongoing third-party funded, investigator-sponsored trials have been submitted in effort to address the December ...
Posted by Michael Wonder on 23 Sep 2025
Idebenone accepted by FDA for priority review for Leber hereditary optic neuropathy
22 September 2025 - Chiesi Global Rare Diseases today announced the US FDA is evaluating the regulatory submission of idebenone to ...
Posted by Michael Wonder on 22 Sep 2025
Update on the US regulatory review of tolebrutinib in non-relapsing, secondary progressive multiple sclerosis
22 September 2025 - The US FDA has extended by three months the target action date of its review of the ...
Posted by Michael Wonder on 21 Sep 2025
Otsuka and Lundbeck receive complete response letter from US FDA for sNDA of Rexulti (brexpiprazole) in combination with sertraline for the treatment of adults with post-traumatic stress disorder
20 September 2025 - Otsuka and Lundbeck) announce that Otsuka has received a Complete Response Letter from the US FDA regarding ...
Posted by Michael Wonder on 11 Sep 2025
FDA files Corcept’s new drug application for relacorilant as a treatment for patients with platinum-resistant ovarian cancer
10 September 2025 - Corcept Therapeutics today announced that the US FDA has accepted Corcept’s new drug application for relacorilant as ...
Posted by Michael Wonder on 10 Sep 2025
FDA accepts biologics license application for Sobi's NASP for patients with uncontrolled gout
10 September 2025 - Sobi today announced that the US FDA has accepted the biologics license application seeking approval for Nanoecapsulated ...
Posted by Michael Wonder on 09 Sep 2025
FDA approves gemcitabine intravesical system for non-muscle invasive bladder cancer
9 September 2025 - Today, the FDA approved gemcitabine intravesical system (Inlexzo, Janssen) for adults with Bacillus Calmette-Guérin unresponsive non-muscle ...
Posted by Michael Wonder on 09 Sep 2025
Saol Therapeutics receives complete response letter from FDA for SL1009 (DCA) for the treatment of pyruvate dehydrogenase complex feficiency
8 September 2025 - Saol is seeking a path forward with the FDA that does not require an additional trial ...
Posted by Michael Wonder on 06 Sep 2025
Accrufer assigned priority review in the US by FDA in children with iron deficiency anaemia
4 September 2025 - Pending successful review, approval in the US is anticipated in 2026. ...
Posted by Michael Wonder on 05 Sep 2025
Agios provides update on US PDUFA goal date for Pyrukynd (mitapivat) in thalassemia
4 September 2025 - Agios Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date for the supplemental ...
Posted by Michael Wonder on 04 Sep 2025
Achieve Life Sciences announces FDA acceptance of cytisinicline new drug application for treatment of nicotine dependence for smoking cessation
3 September 2025 - Achieve Life Sciences today announced that the US FDA has accepted the cytisinicline new drug application for ...
Posted by Michael Wonder on 03 Sep 2025
FDA accepts Shionogi’s ensitrelvir NDA as the first oral therapy for the prevention of COVID-19 following exposure
2 September 2025 - Shionogi announced the US FDA has accepted a new drug application for ensitrelvir fumaric acid, an investigational ...
Posted by Michael Wonder on 03 Sep 2025
Rolling sBLA initiated to the US FDA for Leqembi Iqlik (lecanemab-irmb) as a subcutaneous starting dose for the treatment of early Alzheimer's disease under fast track status
3 September 2025 - BioArctic partner Eisai announced today that they have initiated a rolling submission of the supplemental biologics license ...