Blog
RSS FeedPosted by Michael Wonder on 25 Jul 2025
FDA grants priority review for Addyi (flibanserin) paving the way for expanded access to treat low sexual desire in post-menopausal women
24 July 2025 - Sprout Pharmaceuticals today announced that the US FDA has granted priority review for its supplemental application ...
Posted by Michael Wonder on 24 Jul 2025
Verastem Oncology granted fast track designation for VS-7375 for the treatment of KRAS G12D mutated locally advanced or metastatic pancreatic cancer
24 July 2025 - Enrollment is on-going in US Phase 1/2a trial for VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, ...
Posted by Michael Wonder on 24 Jul 2025
Commissioner's National Priority Voucher Pilot Program
22 July 2025 - Accelerated drug review for companies supporting US national interests. ...
Posted by Michael Wonder on 24 Jul 2025
Avidity Biosciences receives FDA breakthrough therapy designation for delpacibart zotadirsen for the treatment of DMD in people with mutations amenable to exon 44 skipping
23 July 2025 - On track for planned BLA submission for delpacibart zotadirsen at year end 2025. ...
Posted by Michael Wonder on 24 Jul 2025
Anzupgo (delgocitinib) cream is now the first and only FDA approved treatment for moderate to severe chronic hand eczema in adults
23 July 2025 - In Phase 3 clinical trials, patients experienced significant skin clearance along with marked relief from pain and ...
Posted by Michael Wonder on 24 Jul 2025
Revolution Medicines announces FDA breakthrough therapy designation for elironrasib
23 July 2025 - Designation based on encouraging clinical data observed with elironrasib in patients with advanced KRAS G12C non-small ...
Posted by Michael Wonder on 24 Jul 2025
Solid Biosciences receives FDA fast track designation for SGT-501 first in class gene therapy for catecholaminergic polymorphic ventricular tachycardia
23 July 2025 - SGT-501 has now received FDA fast track, orphan drug and rare paediatric disease designations. ...
Posted by Michael Wonder on 23 Jul 2025
GSK announces extension of US FDA an review period for Blenrep (belantamab mafodotin-blmf) in relapsed/refractory multiple myeloma
23 July 2025 - New PDUFA date scheduled for 23 October 2025. ...
Posted by Michael Wonder on 23 Jul 2025
DualityBio's next generation HER3 ADC DB-1310 granted FDA fast track designation
21 July 2025 - DualityBio announced that the US FDA has granted fast track designation to its next-generation HER3 targeting antibody ...
Posted by Michael Wonder on 22 Jul 2025
Replimune receives complete response letter from FDA for RP1 biologics license application for the treatment of advanced melanoma
23 July 2025 - Replimune Group today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 22 Jul 2025
Johnson & Johnson seeks first icotrokinra US FDA approval aiming to revolutionise treatment paradigm for adults and adolescents with plaque psoriasis
21 July 2025 - Icotrokinra is a first in class investigational targeted oral peptide that selectively blocks the IL-23 receptor. ...
Posted by Michael Wonder on 22 Jul 2025
ProMIS Neurosciences granted fast track designation by US FDA for PMN310 in the treatment of Alzheimer’s disease
21 July 2025 - ProMIS Neurosciences today announced that the US FDA has granted fast track designation to PMN310, the ...
Posted by Michael Wonder on 21 Jul 2025
Bristol Myers Squibb’s supplemental new drug application for Sotyktu (deucravacitinib) for the treatment of adults with active psoriatic arthritis accepted for review across four regions globally
21 July 2025 - Bristol Myers Squibb today announced that the US FDA has accepted for review the supplemental new ...
Posted by Michael Wonder on 20 Jul 2025
Rocket Pharmaceuticals receives FDA regenerative medicine advanced therapy designation for RP-A601 gene therapy for PKP2 arhythmogenic cardiomyopathy
17 July 2025 - -- Rocket Pharmaceuticals today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 20 Jul 2025
Genascence announces US FDA grants regenerative medicine advanced therapy designation to GNSC-001 for knee osteoarthritis
16 July 2025 - Genascence Corporation today announced that the US FDA has granted the regenerative medicine advanced therapy designation ...