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RSS FeedPosted 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
Lilly to launch Mounjaro in Korea in August without reimbursement
23 July 2025 - Eli Lilly Korea is moving forward with the launch of its blockbuster Mounjaro (tirzepatide) next month, ...
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
ICER releases draft evidence report on treatment for non-cystic fibrosis bronchiectasis
23 July 2025 - Public comment period now open until 19 August 2025; requests to make oral comment during public ...
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 ...
Posted by Michael Wonder on 19 Jul 2025
Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi
16 July 2025 - Bio-Thera Solutions today announced that the US FDA has accepted its biologics license application for BAT2506, a ...
Posted by Michael Wonder on 18 Jul 2025
Genentech provides update on supplemental biologics license application for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma
18 July 2025 - Genentech announced today that the US FDA issued a complete response letter for Genentech’s supplemental biologics ...