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RSS FeedPosted by Michael Wonder on 10 Apr 2024
FDA accepts filing of new drug application for nalmefene auto-injector for the treatment of known or suspected opioid overdose
8 April 2024 - Purdue Pharma announced today that FDA has accepted for filing the company’s new drug application for the ...
Posted by Michael Wonder on 10 Apr 2024
Lundbeck and Otsuka submit sNDA for FDA review of brexpiprazole and sertraline combination as potential treatment for PTSD
9 April 2024 - Lundbeck and Otsuka have submitted a supplemental new drug application for US FDA review of brexpiprazole ...
Posted by Michael Wonder on 09 Apr 2024
Shorla Oncology announces FDA filing acceptance of new drug application to treat certain forms of leukaemia and other cancers
8 April 2024 - Second FDA acceptance for an NDA filing by Shorla Oncology announced in 2024. ...
Posted by Michael Wonder on 09 Apr 2024
Supernus provides regulatory update for SPN-830
8 April 2024 - Supernus Pharmaceuticals today announced a regulatory update for SPN-830. ...
Posted by Michael Wonder on 08 Apr 2024
Stealth BioTherapeutics announces FDA acceptance of new drug application for elamipretide for the treatment of Barth syndrome
8 April 2024 - If approved, elamipretide would become the first approved therapy for Barth syndrome. ...
Posted by Michael Wonder on 08 Apr 2024
ARS Pharmaceuticals submits response to FDA complete response letter for neffy (epinephrine nasal spray)
3 April 2024 - Submission of complete response letter response triggers up to six month review period by the FDA. ...
Posted by Michael Wonder on 04 Apr 2024
FDA accepts supplemental biologics license applications for Bimzelx (bimekizumab-bkzx) for moderate to severe hidradenitis suppurativa and additional 2 mL device presentations
4 April 2024 - Application in moderate to severe hidradenitis suppurativa based on results from two Phase 3 studies where ...
Posted by Michael Wonder on 03 Apr 2024
Zanidatamab biologics license application for previously treated HER2 positive metastatic biliary tract cancer completed
2 April 2024 - Zymeworks is pleased to announce, along with our partners Jazz Pharmaceuticals, completion of the rolling submission of ...
Posted by Michael Wonder on 02 Apr 2024
Datopotamab deruxtecan biologics license application accepted in the US for patients with previously treated metastatic HR positive, HER2 negative breast cancer
2 April 2024 - Application based on results from the TROPION-Breast01 Phase 3 trial. ...
Posted by Michael Wonder on 01 Apr 2024
Eisai completes submission of Leqembi (lecanemab-irmb) supplemental biologics license application for IV maintenance dosing for the treatment of early Alzheimer’s disease to the US FDA
1 April 2024 - Eisai and Biogen announced today that Eisai submitted to the US FDA a supplemental biologics license ...
Posted by Michael Wonder on 01 Apr 2024
US FDA accepts Astellas’ supplemental new drug application for Izervay (avacincaptad pegol intravitreal solution) for geographic atrophy
1 April 2024 - Target action date set for 19 November 2024. ...
Posted by Michael Wonder on 27 Mar 2024
Syndax announces FDA priority review of NDA for revumenib for the treatment of relapsed/refractory KMT2Ar acute leukaemia
26 March 2024 - PDUFA action date set for 26 September 2024. ...
Posted by Michael Wonder on 20 Mar 2024
US FDA approves Idorsia’s once-daily Tryvio (aprocitentan) – the first and only endothelin receptor antagonist for the treatment of high blood pressure not adequately controlled in combination with other antihypertensives
20 March 2024 - Idorsia plans to make Tryvio available to the millions of patients in the US who are not ...
Posted by Michael Wonder on 19 Mar 2024
Citius Pharmaceuticals announces FDA acceptance of the BLA resubmission of Lymphir (denileukin diftitox) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma
18 March 2024 - FDA assigns Prescription Drug User Fee Act target action date of 13 August 2024 ...
Posted by Michael Wonder on 12 Mar 2024
Johnson & Johnson submits supplemental biologics license application to US FDA seeking approval of Tremfya (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis
11 March 2024 - Submission is supported by data from the Phase 3 QUASAR program, which showed a significantly greater percentage ...