Blog
RSS FeedPosted by Michael Wonder on 23 Sep 2025
FDA issues complete response letter for apitegromab as a treatment for patients with spinal muscular atrophy
23 September 2025 - No other approvability issues cited in complete response letter. ...
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 23 Sep 2025
FDA takes action to make a treatment available for autism symptoms
22 September 2025 - The US FDA today initiated the approval of leucovorin calcium tablets for patients with cerebral folate ...
Posted by Michael Wonder on 23 Sep 2025
MavriX Bio receives FDA fast track designation for MVX-220 for treatment of Angelman syndrome
22 September 2025 - MavriX Bio today announced that the US FDA has granted fast track designation for MVX-220, an investigational ...
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 22 Sep 2025
Tremfya (guselkumab) achieves US approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen
19 September 2025 - Johnson & Johnson is initiating a head to head study seeking to demonstrate the superiority of Tremfya ...
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 19 Sep 2025
FDA grants accelerated approval to first treatment for Barth syndrome
19 September 2025 - New treatment for Barth syndrome showcases FDA’s commitment to bringing effective and safe medications to patients in ...
Posted by Michael Wonder on 19 Sep 2025
Incyte announces additional FDA approval of Opzelura (ruxolitinib) cream in children ages 2-11 with atopic dermatitis
18 September 2025 - Opzelura is the first topical Janus kinase inhibitor approved in the US for paediatric atopic dermatitis. ...
Posted by Michael Wonder on 19 Sep 2025
FDA approves pembrolizumab and berahyaluronidase alfa-pmph for subcutaneous injection
19 September 2025 - Today, the FDA approved pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) for subcutaneous injection for adult ...
Posted by Michael Wonder on 19 Sep 2025
Biocon Biologics receives US FDA approval for Bosaya and Aukelso, denosumab biosimilars
17 September 2025 - Biocon Biologics today announced that the US FDA has approved Bosaya (denosumab-kyqq) 60 mg/mL injection for subcutaneous ...
Posted by Michael Wonder on 18 Sep 2025
Minovia Therapeutics receives FDA fast track designation for MNV-201 in myelodysplastic syndrome
18 September 2025 - Minovia Therapeutics announces that the US FDA has granted fast track designation to the Company’s lead investigational ...
Posted by Michael Wonder on 18 Sep 2025
Anti-MTBR (microtubule binding region) tau antibody etalanetug granted FDA fast track designation
16 September 2025 - Eisai announced today that etalanetug (E2814), an investigational anti-MTBR (microtubule binding region) tau antibody, was granted fast ...
Posted by Michael Wonder on 17 Sep 2025
Corstasis Therapeutics announces FDA approval of Enbumyst (bumetanide nasal spray) for the treatment of oedema associated with congestive heart failure, liver disease and kidney disease
15 September 2025 - Enbumyst is the first and only intranasal loop diuretic approved in the US offering a self-administered alternative ...