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RSS FeedPosted by Michael Wonder on 19 Jun 2025
Lilly to offer all approved doses of Zepbound (tirzepatide) single-dose vials through LillyDirect Self Pay Pharmacy Solutions
16 June 2025 - With the addition of 12.5 mg and 15 mg vials, all approved doses of Zepbound will be ...
Posted by Michael Wonder on 18 Jun 2025
FDA to issue new Commissioner’s national priority vouchers to companies supporting US national interests
17 June 2025 - The US FDA today announced its Commissioner’s National Priority Voucher program to enhance the health interests of ...
Posted by Michael Wonder on 18 Jun 2025
Aldeyra Therapeutics resubmits reproxalap new drug application for the treatment of dry eye disease
17 June 2025 - Aldeyra Therapeutics today announced the resubmission of a new drug application to the US FDA for ...
Posted by Michael Wonder on 18 Jun 2025
FDA approves tafasitamab-cxix for relapsed or refractory follicular lymphoma
18 June 2025 - Today, the FDA approved tafasitamab-cxix (Monjuvi, Incyte) with lenalidomide and rituximab for adults with relapsed or ...
Posted by Michael Wonder on 18 Jun 2025
Yeztugo (lenacapavir) is now the first and only FDA approved HIV prevention option offering 6 months of protection
18 June 2025 - Approval based on Phase 3 PURPOSE 1 and PURPOSE 2 data that showed ≥99.9% of participants remained ...
Posted by Michael Wonder on 18 Jun 2025
Duke Street Bio receives FDA fast track designation for DSB2455
10 June 2025 - Duke Street Bio today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track ...
Posted by Michael Wonder on 18 Jun 2025
Dyne Therapeutics announces FDA breakthrough therapy designation for DYNE-101
17 June 2025 - - Dyne Therapeutics today announced that the US FDA has granted breakthrough therapy designation to DYNE-101 for ...
Posted by Michael Wonder on 18 Jun 2025
BioAegis Therapeutics receives FDA fast track designation for lead product, recombinant human gelsolin, for the treatment of acute respiratory distress syndrome
17 June 2025 - BioAegis Therapeutics announces that the US FDA has granted fast track designation to its lead product candidate, ...
Posted 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
Tisento Therapeutics receives US FDA fast track designation for zagociguat for the treatment of MELA
17 June 2025 - Global Phase 2b PRIZM study of zagociguat is currently enrolling participants with MELAS. ...
Posted by Michael Wonder on 17 Jun 2025
Ferrer receives FDA fast track designation for FNP-223 in progressive supranuclear palsy
17 June 2025 - Ferrer has announced that FNP-223, a novel therapy in-licensed from Asceneuron and aimed at slowing the development ...
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
SolasCure receives FDA fast track designation for Aurase wound gel to treat calciphylaxis ulcers
16 June 2025 - Solascure today announced that the US FDA has granted fast track designation for its investigational Aurase wound ...
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 ...