Blog
RSS FeedPosted by Michael Wonder on 29 Jul 2024
Luye Pharma announces US FDA approval of Erzofri (paliperidone palmitate) extended release injectable suspension for treating schizophrenia and schizoaffective disorder
28 July 2024 - Luye Pharma today announced that the US FDA has approved the company's Erzofri (paliperidone palmitate) extended-release injectable ...
Posted by Michael Wonder on 27 Jul 2024
US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata
25 July 2024 - Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials. ...
Posted by Michael Wonder on 26 Jul 2024
Mirum’s Livmarli now approved for PFIC in patients 12 months and older
25 July 2024 - Mirum Pharmaceuticals today announced that the US FDA has approved a label expansion for Livmarli (maralixibat) oral ...
Posted by Michael Wonder on 26 Jul 2024
US FDA approves BioMarin's Brineura (cerliponase alfa) for children under 3 years with CLN2 disease
24 July 2024 - Now approved for children of all ages with CLN2 Batten disease, regardless of whether they yet ...
Posted by Michael Wonder on 23 Jul 2024
FDA approves Samsung Bioepis’ Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab)
22 July 2024 - Epysqli is approved for the treatment of patients with paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome. ...
Posted by Michael Wonder on 19 Jul 2024
Phathom Pharmaceuticals announces FDA approval of Voquenza (vonoprazan) tablets for the relief of heartburn associated with non-erosive GERD in adults
18 July 2024 - Voquenza met its primary endpoint in its Phase 3 pivotal trial by demonstrating a significant and rapid ...
Posted by Michael Wonder on 19 Jul 2024
Orexo shares new information on OX124, a high dose naloxone rescue medication in development for opioid overdose
16 July 2024 - Orexo today announces that the company has received a complete response letter from the US FDA regarding ...
Posted by Michael Wonder on 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
Posted by Michael Wonder on 09 Jul 2024
FDA approves Arcutis’ Zorvye (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age
9 July 2024 - Commercial product expected to be available by the end of July. ...
Posted by Michael Wonder on 07 Jul 2024
FDA approves Genentech’s Vabysmo pre-filled syringe for three leading causes of vision loss
4 July 2024 - Vabysmo PFS is the first and only syringe pre-filled with an FDA approved bi-specific antibody to treat ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...
Posted by Michael Wonder on 02 Jul 2024
FDA approves treatment for adults with Alzheimer’s disease
2 July 2024 - The US FDA has approved Kisunla (donanemab-azbt) injection for the treatment of Alzheimer’s disease. ...
Posted by Michael Wonder on 01 Jul 2024
FDA grants approval for Eylea biosimilar FYB203/Azhantive (aflibercept-mrbb)
28 June 2024 - Formycon and its licensing partner Klinge Biopharma announce that the US FDA today approved FYB203/Azhantive (aflibercept-mrbb), ...
Posted by Michael Wonder on 01 Jul 2024
FDA approves biosimilar Pyzchiva (ustekinumab-ttwe), to be commercialised by Sandoz in US
1 July 2024 - FDA granted provisional determination for interchangeability designation for Pyzchiva. ...
Posted by Michael Wonder on 29 Jun 2024
Rocket Pharmaceuticals provides regulatory update on Kresladi (marnetegragene autotemcel)
28 June 2024 - Rocket Pharmaceuticals today announced a regulatory update for Kresladi (marnetegragene autotemcel), a lentiviral vector-based gene therapy ...