Blog
RSS FeedPosted by Michael Wonder on 11 Dec 2024
Krystal Biotech provides update on EMA’s on-going regulatory review of B-VEC for dystrophic epidermolysis bullosa
9 December 2024 - CHMP opinion now expected in Q1, 2025. ...
Posted by Michael Wonder on 10 Dec 2024
Chiesi Global Rare Diseases and Protalix BioTherapeutics announce validation of variation submission by EMA for pegunigalsidase alfa
9 December 2024 - Application to label a less frequent dosing regimen at a dose of 2 mg/kg body weight ...
Posted by Michael Wonder on 10 Dec 2024
US FDA accepts GSK’s submission for the use of Nucala (mepolizumab) in COPD
9 December 2024 - Submission supported by MATINEE data showing significant and clinically meaningful reduction in annualised rate of moderate/severe exacerbations ...
Posted by Michael Wonder on 07 Dec 2024
FDA accepts supplemental biologics license application for Roche’s Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
5 December 2024 - Application is based on data from the Phase 3 STARGLO study where Columvi plus chemotherapy showed a ...
Posted by Michael Wonder on 07 Dec 2024
Imfinzi granted priority review in the US for patients with muscle-invasive bladder cancer
6 December 2024 - Decision based on NIAGARA Phase 3 trial results which demonstrated a statistically significant and clinically meaningful ...
Posted by Michael Wonder on 07 Dec 2024
Saol Therapeutics announces submission of new drug application to the US FDA for SL1009
3 December 2024 - Saol Therapeutics today announced the submission of a new drug application to the US FDA for approval ...
Posted by Michael Wonder on 06 Dec 2024
Johnson & Johnson seeks US FDA approval for first paediatric indications for Tremfya (guselkumab)
2 December 2024 - Applications filed for Tremfya to treat children with moderate to severe plaque psoriasis and active juvenile psoriatic ...
Posted by Michael Wonder on 06 Dec 2024
Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk
2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...
Posted by Michael Wonder on 06 Dec 2024
Otsuka submits new drug application in Japan for bempedoic acid in the treatment of hypercholesterolaemia
26 November 2024 - Otsuka announces the submission of a new drug application to the Japanese Ministry of Health, Labour ...
Posted by Michael Wonder on 05 Dec 2024
Applied Therapeutics receives complete response letter from US FDA regarding new drug application for govorestat for classic galactosaemia
27 November 2024 - Applied Therapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 05 Dec 2024
Exelixis provides regulatory update related to supplemental new drug application for cabozantinib (Cabometyx) for the treatment of patients with previously treated advanced neuroendocrine tumors
26 November 2024 - 26, 2024-- Exelixis today announced that the US FDA has notified the company that the supplemental new ...
Posted by Michael Wonder on 04 Dec 2024
Theratechnologies submits updated tesamorelin F8 formulation sBLA for FDA review
26 November 2024 - Resubmission addresses questions raised in January 2024 complete response letter. ...
Posted by Michael Wonder on 04 Dec 2024
Valneva submits label extension application for its Chikungunya vaccine, Ixchiq, to the US FDA
26 November 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 04 Dec 2024
Soleno Therapeutics announces FDA extension of review period for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
26 November 2024 - PDUFA target action date extended by three months to 27 March 2025. ...
Posted by Michael Wonder on 04 Dec 2024
Anavex Life Sciences announces submission of blarcamesine MAA for treatment of Alzheimer’s disease to EMA
26 November 2024 - First marketing authorisation submission for blarcamesine. ...