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RSS FeedPosted by Michael Wonder on 12 Nov 2024
Datopotamab deruxtecan new BLA submitted for accelerated approval in the US for patients with previously treated advanced EGFR mutated non-small cell lung cancer
12 November 2024 - Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 Phase 2 trial and supported ...
Posted 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
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 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
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
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
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 ...
Posted by Michael Wonder on 06 Nov 2024
Merus receives FDA extension of PDUFA for zenocutuzumab
5 November 2024 - Merus today announced that the US FDA has extended the PDUFA goal date for zenocutuzumab biologics ...
Posted by Michael Wonder on 05 Nov 2024
Update on FDA review of Vtama (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older
5 November 2024 - Organon today announced that the US FDA extended by three months the target action date of its ...
Posted by Michael Wonder on 05 Nov 2024
Electra Therapeutics receives FDA fast track designation for ELA026 in secondary haemophagocytic lymphohistiocytosis
4 November 2024 - Electra Therapeutics today announced that the US FDA has granted fast track designation for ELA026 for ...
Posted by Michael Wonder on 04 Nov 2024
Ionis announces FDA acceptance of new drug application for donidalorsen for prophylactic treatment of HAE
4 November 2024 - Donidalorsen PDUFA date set for 21 August 2025. ...
Posted by Michael Wonder on 03 Nov 2024
Protega Pharmaceuticals receives FDA approval for Roxybond (oxycodone hydrochloride) immediate release 10 mg tablet with abuse deterrent technology for management of pain
29 October 2024 - Patented SentryBond technology, a first of its kind abuse deterrent technology, is designed to provide multiple levels ...