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RSS FeedPosted by Michael Wonder on 18 Jun 2025
Johnson & Johnson seeks US FDA approval of Stelara (ustekinumab) for the treatment of paediatric Crohn’s disease
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication ...
Posted by Michael Wonder on 17 Jun 2025
Milestone Pharmaceuticals submits response to the FDA’s CRL for Cardamyst (etripamil) nasal spray for PSVT following type A meeting
16 June 2025 - Milestone Pharmaceuticals today announced submission of its response to the US FDA’s complete response letter regarding its ...
Posted by Michael Wonder on 17 Jun 2025
US FDA approves CSL's Andembry (garadacimab-gxii), the only prophylactic hereditary angioedema treatment targeting factor XIIa with once monthly dosing for all patients from the start
16 June 2025 - Once monthly dosing reduced HAE attacks by a median of more than 99% and a least squares ...
Posted by Michael Wonder on 16 Jun 2025
Aquestive Therapeutics announces FDA acceptance of new drug application and PDUFA date for Anaphylm for the treatment of severe allergic reactions
16 June 2025 - FDA assigns PDUFA target action date of 31 January 2026 ...
Posted by Michael Wonder on 16 Jun 2025
KalVista Pharmaceuticals announces FDA will not meet PDUFA goal date for sebetralstat NDA for hereditary angioedema due to FDA resource constraints
13 June 2025 - Agency indicates anticipated decision within four weeks ...
Posted by Michael Wonder on 13 Jun 2025
FDA grants priority review for zoliflodacin new drug application for the treatment of uncomplicated gonorrhoea
12 June 2025 - Innoviva Specialty Therapeutics today announced that the US FDA has granted priority review for the new drug ...
Posted by Michael Wonder on 10 Jun 2025
Zepzelca (lurbinectedin) and atezolizumab (Tecentriq) combination granted US FDA priority review for first-line maintenance treatment of extensive-stage small cell lung cancer
10 June 2025 - Target action (PDUFA) date set for 7 October 2025. ...
Posted by Michael Wonder on 10 Jun 2025
Axsome Therapeutics provides update on the new drug application for AXS-14 for the management of fibromyalgia
9 June 2025 - Axsome Therapeutics today announced it has received a refusal to file letter from the US FDA ...
Posted by Michael Wonder on 06 Jun 2025
Arvinas announces submission of new drug application to US FDA for vepdegestrant for patients with ESR1 mutated ER+/HER2- advanced or metastatic breast cancer
6 June 2025 - Arvinas today announced the submission of a new drug application to the US FDA with its partner ...
Posted by Michael Wonder on 05 Jun 2025
Linerixibat new drug application accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis
2 June 2025 - GSK today announced the US FDA has accepted for review the new drug application for linerixibat, an ...
Posted by Michael Wonder on 02 Jun 2025
FDA accepts TransCon CNP NDA for priority review
2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application ...
Posted by Michael Wonder on 02 Jun 2025
Kura Oncology and Kyowa Kirin announce FDA acceptance and priority review of new drug application for ziftomenib in adults with relapsed or refractory NPM1 mutant AML
1 June 2025 - New drug application based on positive results from the Phase 2 KOMET-001 trial. ...
Posted by Michael Wonder on 29 May 2025
Patritumab deruxtecan biologics license application for patients with previously treated locally advanced or metastatic EGFR mutated non-small cell lung cancer voluntarily withdrawn
29 May 2025 - The biologics license application seeking accelerated approval in the US for Daiichi Sankyo and Merck's patritumab ...
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 ...