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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
FDA accepts Telix NDA for new prostate cancer imaging agent
23 July 2024 - Telix today announces that the US FDA has accepted the filing of its new drug application for ...
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
AffyImmune receives FDA regenerative medicine advanced therapy designation for AIC100 in recurrent anaplastic thyroid cancer
23 July 2024 - RMAT designation follows FDA’s review of available preliminary clinical evidence that AIC100 has the potential to address ...
Posted by Michael Wonder on 30 Jul 2024
ICER to assess treatment for acute pain
29 July 2024 - Report will be subject of Midwest CEPAC meeting in February 2025; draft scoping document open to ...
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 29 Jul 2024
Luye Pharma announces US FDA approval of Erzofri (paliperidone palmitate) extended release injectable suspension for treating schizophrenia and schizoaffective disorder
28 July 2024 - Luye Pharma today announced that the US FDA has approved the company's Erzofri (paliperidone palmitate) extended-release injectable ...
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 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 ...