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RSS FeedPosted by Michael Wonder on 02 Dec 2023
FDA grants priority review to Merck’s application for Keytruda (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) for the first-line treatment of patients with locally advanced or metastatic urothelial cancer
30 November 2023 - Acceptance based on results from the Phase 3 KEYNOTE-A39 trial, which showed a statistically significant and ...
Posted by Michael Wonder on 30 Nov 2023
FDA grants priority review for supplemental biologics license application of Padcev (enfortumab vedotin-ejfv) with Keytruda (pembrolizumab) for first-line treatment of advanced bladder cancer
30 November 2023 - Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and ...
Posted by Michael Wonder on 30 Nov 2023
Formycon and Fresenius Kabi announce file acceptance for FYB202, a biosimilar candidate to Stelara (ustekinumab), by the US FDA
30 November 2023 - Formycon and its commercialisation partner Fresenius Kabi today announced that the US FDA has accepted the biologics ...
Posted by Michael Wonder on 30 Nov 2023
FDA accepts Arcutis’ supplemental new drug application for roflumilast 0.15% cream for the treatment of atopic dermatitis in adults and children down to age 6
29 November 2023 - FDA has set a PDUFA target action date of 7 July 2024. ...
Posted by Michael Wonder on 29 Nov 2023
Karuna Therapeutics announces US FDA accepts new drug application for KarXT for the treatment of schizophrenia
29 November 2023 - PDUFA action date is 26 September 2024. ...
Posted by Michael Wonder on 28 Nov 2023
Orexo announces FDA acceptance of new drug application filing for OX124, a high-dose rescue medication for opioid overdose
28 November 2023 - PDUFA set to 15 July 2024. If approved, US launch is expected to be initiated late ...
Posted by Michael Wonder on 28 Nov 2023
Autolus Therapeutics submits biologics license application to US FDA for obecabtagene autoleucel (obe-cel) for patients with relapsed/refractory adult B-cell acute lymphoblastic leukaemia
27 November 2023 - BLA submission includes results from pivotal Phase 2 FELIX study evaluating obe-cel in relapsed/refractory adult B-cell acute ...
Posted by Michael Wonder on 28 Nov 2023
Abeona Therapeutics announces FDA accepts and grants priority review for Pz-cel biologics license application
27 November 2023 - PDUFA target action date is 25 May 2024. ...
Posted by Michael Wonder on 20 Nov 2023
Janssen submits supplemental biologics license application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus chemotherapy for the treatment of patients with EGFR mutated non-small-cell lung cancer who progressed on or after osimertinib
20 November 2023 - This submission is supported by data from the Phase 3 MARIPOSA-2 Study featured in a Late-Breaking Presidential ...
Posted by Michael Wonder on 18 Nov 2023
Polaris Group initiates rolling submission of biologic license application for ADI-PEG 20 with US FDA to treat malignant pleural mesothelioma
16 November 2023 - Polaris Group today announced that the Company has initiated the rolling submission of its biologic license ...
Posted by Michael Wonder on 16 Nov 2023
Ascendis Pharma resubmits NDA for TransCon PTH to the US FDA
15 November 2023 - Ascendis Pharma today announced that it has resubmitted its new drug application for TransCon PTH (palopegteriparatide) for ...
Posted by Michael Wonder on 09 Nov 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Breyanzi (lisocabtagene maraleucel) for relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma
9 November 2023 - Application based on results from TRANSCEND CLL 004, the first pivotal multi-centre trial to show clinical benefit ...
Posted by Michael Wonder on 08 Nov 2023
Samsung Bioepis & Organon announce FDA acceptance of supplemental biologics license application for interchangeability designation for Hadlima (adalimumab-bwwd), a biosimilar to Humira
7 November 2023 - Supplemental biologics license application based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: ...
Posted by Michael Wonder on 08 Nov 2023
Janssen submits Phase 3 study data to the European Medicines Agency and US Food and Drug Administration for Sirturo (bedaquiline)
7 November 2023 - STREAM Stage 2 study data submitted as part of type II variation to the EMA and supplemental ...
Posted by Michael Wonder on 02 Nov 2023
Supernus announces SPN-830 apomorphine infusion device NDA accepted for review by FDA
2 November 2023 - PDUFA target action date of 5 April 2024. ...