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RSS FeedPosted by Michael Wonder on 29 May 2025
Pfizer and BioNTech submit EMA application for COVID-19 vaccine targeting LP.8.1 for 2025-2026 season
28 May 2025 - 2025 -- Pfizer and BioNTech today announced that they have submitted a regulatory application to the ...
Posted by Michael Wonder on 28 May 2025
US FDA accepts new drug application under priority review for sevabertinib (BAY 2927088) in HER2 mutant non-small cell lung cancer
28 May 2025 - Regulatory submission is based on positive results from the on-going Phase I/II SOHO-01 trial in patients with ...
Posted by Michael Wonder on 27 May 2025
Savara receives refusal to file letter from the US FDA for the biologics license application for Molbreevi to treat patients with auto-immune pulmonary alveolar proteinosis
27 May 2025 - Savara today announced that the Company received a refusal to file letter from the FDA for ...
Posted by Michael Wonder on 27 May 2025
GSK's depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
26 May 2025 - GSK has submitted a new drug submission to Health Canada for depemokimab for two proposed indications: the ...
Posted by Michael Wonder on 26 May 2025
Otsuka announces FDA acceptance and priority review of biologics license application for sibeprenlimab in the treatment of immunoglobulin A nephropathy
26 May 2025 - Otsuka Pharmaceutical today announce the US FDA has accepted for review the biologics license application for ...
Posted by Michael Wonder on 25 May 2025
Moderna files FDA application for the LP.8.1 targeting COVID-19 vaccine
23 May 2025 - Moderna today announced that it has submitted an application to the US FDA for review of its ...
Posted by Michael Wonder on 25 May 2025
Xbrane Biopharma updates on US FDA biologics license application for its investigational biosimilar candidate to Lucentis (ranibizumab)
23 May 2025 - Xbrane re-submitted the biologics license application) for its investigational biosimilar candidate to Lucentis (ranibizumab) to the US ...
Posted by Michael Wonder on 23 May 2025
Soleno Therapeutics announces submission and EMA validation of marketing authorisation application for diazoxide choline prolonged release tablets for the treatment of hyperphagia in patients with Prader-Willi syndrome
22 May 2025 - Soleno Therapeutics today announced that Soleno’s marketing authorisation application seeking regulatory approval of diazoxide choline prolonged release ...
Posted by Michael Wonder on 22 May 2025
PharmaMar has submitted EU marketing authorization application for lurbinectedin in combination with atezolizumab in first-line maintenance therapy for extensive-stage small cell lung cancer
21 May 2025 - PharmaMar has submitted a marketing authorisation application to the EMA for Zepzelca (lurbinectedin) in combination with ...
Posted by Michael Wonder on 21 May 2025
Moderna provides update on BLA submission for combination vaccine against influenza and COVID-19
21 May 2025 - Moderna today announced that in consultation with the US FDA, the Company has voluntarily withdrawn the ...
Posted by Michael Wonder on 17 May 2025
PharmaTher announces FDA extends review period for ketamine; new approval goal date 9 August 2025
16 May 2025 - PharmaTher today announced the US FDA has extended the approval goal date for the review of ...
Posted by Michael Wonder on 15 May 2025
FDA sets PDUFA date for Xspray Pharma’s re-submitted application for Dasynoc
14 May 2025 - The US FDA has acknowledged receipt of Xspray Pharma's re-submitted new drug application) for Dasynoc. ...
Posted by Michael Wonder on 15 May 2025
FDA extends PDUFA date of Biohaven's troriluzole NDA for rare disease spinocerebellar ataxia
14 May 2025 - Troriluzole would be the first and only FDA approved treatment for spinocerebellar ataxia, if approved. ...
Posted by Michael Wonder on 15 May 2025
BioCryst announces FDA acceptance of NDA for Orladeyo (berotralstat) oral granules in patients with hereditary angioedema aged 2 to 11 years
14 May 2025 - FDA grants priority review of application, with PDUFA target action date of 12 September 2025. ...
Posted by Michael Wonder on 13 May 2025
RegenxBio announces FDA acceptance and priority review of the BLA for RGX-121 for MPS II
13 May 2025 - FDA assigns PDUFA target action date of 9 November 2025. ...