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RSS FeedPosted by Michael Wonder on 12 Nov 2024
Unicycive Therapeutics announces US FDA acceptance of the new drug application for oxylanthanum carbonate for the treatment of hyperphosphataemia in patients with chronic kidney disease on dialysis
11 November 2024 - FDA sets PDUFA action date of 28 June 2025. ...
Posted by Michael Wonder on 12 Nov 2024
Neurotech provides update on BLA for NT-501 as a treatment for macular telangiectasia type 2
8 November 2024 - Neurotech Pharmaceuticals today announced that the US FDA has extended the PDUFA goal date by three months ...
Posted by Michael Wonder on 12 Nov 2024
Nipocalimab is the first and only investigational therapy granted US FDA breakthrough therapy designation for the treatment of adults living with moderate to severe Sjögren’s disease
11 November 2024 - The breakthrough therapy designation for investigational nipocalimab in Sjögren’s disease, a prevalent autoantibody disease with no approved ...
Posted by Michael Wonder on 09 Nov 2024
Caris Life Sciences receives FDA approval for MI Cancer Seek as a companion diagnostic test
6 November 2024 - MI Cancer Seek is the first and only simultaneous whole exome and whole transcriptome-based assay with ...
Posted by Michael Wonder on 09 Nov 2024
Moderna receives Health Canada approval for RSV vaccine for adults aged 60 years and older
8 November 2024 - mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only ...
Posted by Michael Wonder on 08 Nov 2024
Dizal submits new drug application to the US FDA for sunvozertinib in treating relapsed or refractory non-small cell lung cancer with EGFR exon 20 insertion mutations
8 November 2024 - The submission is supported by data from the pivotal WU-KONG1 Part B study, which featured in an ...
Posted by Michael Wonder on 08 Nov 2024
Johnson & Johnson submits applications in the US and EU seeking approval of Darzalex Faspro/Darzalex as subcutaneous monotherapy for high risk smoldering multiple myeloma
8 November 2024 - If approved, Darzalex Faspro will become the first treatment option for patients with smoldering multiple myeloma at ...
Posted by Michael Wonder on 08 Nov 2024
FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia
8 November 2024 - Today, the FDA approved obecabtagene autoleucel (Aucatzyl, Autolus), a CD19 directed genetically modified autologous T cell ...
Posted by Michael Wonder on 08 Nov 2024
Cumberland Pharmaceuticals receives FDA orphan drug and rare paediatric disease designations for new treatment of Duchenne muscular dystrophy
6 November 2024 - Cumberland Pharmaceuticals announced today that the US FDA granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 08 Nov 2024
AskBio receives FDA rare paediatric disease and orphan drug designations for AB-1003 for the treatment of limb girdle muscular dystrophy type 2I/R9
7 November 2024 - First patient dosed in Phase 1/Phase 2 LION-CS101 trial of AB-1003 in August 2023, with enrolment ...
Posted by Michael Wonder on 06 Nov 2024
Satsuma Pharmaceuticals and SNBL resubmits the new drug application for STS101 (dihydroergotamine nasal powder) for the acute treatment of migraine with or without aura
30 October 2024 - Satsuma Pharmaceuticals and its corporate parent, Shin Nippon today announced the resubmission of the new drug ...
Posted by Michael Wonder on 06 Nov 2024
Dupixent (dupilumab) approved in the European Union as the first and only medicine for young children with eosinophilic oesophagitis
6 November 2024 - Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on ...
Posted by Michael Wonder on 06 Nov 2024
Acadia Pharmaceuticals enters into an agreement to sell its rare paediatric disease priority review voucher for $150 million
5 November 2024 - Acadia Pharmaceuticals today announced that it entered into a definitive asset purchase agreement to sell its ...
Posted by Michael Wonder on 06 Nov 2024
Expanded age indication for GSK's Arexvy, the first respiratory syncytial virus vaccine approved in Canada for adults aged 50-59 at increased risk
5 November 2024 - Clinical development program continues to evaluate safety and immunogenicity in adults aged 18-49 at increased risk ...
Posted by Michael Wonder on 06 Nov 2024
Journey Medical announces US FDA approval of Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for the treatment of rosacea
4 November 2024 - Journey Medical today announced that the FDA has approved Emrosi (minocycline hydrochloride extended release capsules, 40 ...