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RSS FeedPosted 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
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 ...
Posted by Michael Wonder on 02 Nov 2024
Alvotech and Teva announce US FDA approval of additional presentation of Selarsdi (ustekinumab-aekn), expanding its label to include further indications approved for reference product, Stelara (ustekinumab)
22 October 2024 - Approval of Selarsdi 130 mg/26 mL in a single dose vial for intravenous infusion expands label to ...
Posted by Michael Wonder on 01 Nov 2024
FELIQS receives US FDA fast track designation for FLQ-101, a first in class small molecule to prevent retinopathy of prematurity
1 November 2024 - FELIQS announced today that the US FDA has granted its lead asset, FLQ-101, fast track designation for ...
Posted by Michael Wonder on 01 Nov 2024
Eisai completes rolling submission to US FDA for Leqembi (lecanemab-irmb) biologics license application for subcutaneous maintenance dosing for the treatment of early Alzheimer’s disease under the fast track status
31 October 2024 - Eisai and Biogen announced today that Eisai has completed the rolling submission of a biologics license application ...
Posted by Michael Wonder on 31 Oct 2024
Verastem Oncology completes rolling NDA submission to the FDA for avutometinib plus defactinib as a treatment for recurrent KRAS mutant low grade serous ovarian cancer
31 October 2024 - Company seeking accelerated approval and priority review of its new drug application submission in patients with KRAS ...