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RSS FeedPosted by Michael Wonder on 30 Jul 2024
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for multiple myeloma
30 July 2024 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen) in combination with bortezomib, lenalidomide, and ...
Posted by Michael Wonder on 30 Jul 2024
Vertex announces FDA acceptance of new drug application for suzetrigine for the treatment of moderate to severe acute pain
30 July 2024 - FDA grants priority review and assigns a PDUFA target action date of 30 January 2025. ...
Posted by Michael Wonder on 30 Jul 2024
Alpha Cognition’s oral therapy Zunveyl receives FDA approval to treat Alzheimer's disease
29 July 2024 - The second oral therapy approved this decade, Zunveyl's dual MOA was designed to eliminate drug absorption in ...
Posted by Michael Wonder on 30 Jul 2024
Novartis Scemblix granted FDA priority review for the treatment of adults with newly diagnosed CML
29 July 2024 - Priority review based on ASC4FIRST Phase 3 study with Scemblix data first to show significantly improved molecular ...
Posted by Michael Wonder on 30 Jul 2024
Syndax announces PDUFA action date extension for revumenib NDA for relapsed or refractory KMT2Ar acute leukaemia
29 July 2024 - New PDUFA action date of 26 December 2024 allows FDA additional time to complete their review. ...
Posted by Michael Wonder on 27 Jul 2024
US FDA approves Leqselvi (deuruxolitinib), an oral JAK inhibitor for the treatment of severe alopecia areata
25 July 2024 - Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials. ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 26 Jul 2024
Checkpoint Therapeutics announces FDA acceptance of BLA resubmission of cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma
25 July 2024 - PDUFA goal date of 28 December 2024 set by FDA. ...
Posted by Michael Wonder on 26 Jul 2024
Mirum’s Livmarli now approved for PFIC in patients 12 months and older
25 July 2024 - Mirum Pharmaceuticals today announced that the US FDA has approved a label expansion for Livmarli (maralixibat) oral ...
Posted by Michael Wonder on 26 Jul 2024
Tonix Pharmaceuticals granted fast track designation by FDA for Tonmya for fibromyalgia
25 July 2024 - NDA submission on track for second half 2024. ...
Posted by Michael Wonder on 26 Jul 2024
AC Immune’s ACI-35.030 (now “JNJ-2056”) granted FDA fast track designation for Alzheimer’s aisease
25 July 2024 - Treatment of first randomised person with pre-clinical Alzheimer's disease expected this quarter. ...
Posted by Michael Wonder on 26 Jul 2024
US FDA approves BioMarin's Brineura (cerliponase alfa) for children under 3 years with CLN2 disease
24 July 2024 - Now approved for children of all ages with CLN2 Batten disease, regardless of whether they yet ...
Posted by Michael Wonder on 26 Jul 2024
Arcutis submits supplemental new drug application for Zorvye (roflumilast) foam to the FDA for the treatment of scalp and body psoriasis in adults and adolescents ages 12 and over
23 July 2024 - Once daily Zorvye foam significantly improved both scalp and body psoriasis in a Phase 2b and a ...
Posted by Michael Wonder on 25 Jul 2024
Bio-Thera Solutions announces regulatory filing acceptance for BAT2206, a proposed biosimilar to Stelara in the US and EU
24 July 2024 - The BAT2206 BLA and MAA are based on a robust analytical, non-clinical and clinical data package ...
Posted by Michael Wonder on 25 Jul 2024
ConSynance Therapeutics receives FDA rare paediatric disease designation for CSTI-500 in Prader-Willi syndrome
24 July 2024 - ConSynance Therapeutics today announced that the US FDA has granted rare paediatric disease designation to its ...