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RSS FeedPosted by Michael Wonder on 23 Dec 2023
Patritumab deruxtecan granted priority review in the US for certain patients with previously treated locally advanced or metastatic EGFR mutated non-small-cell lung cancer
22 December 2023 - Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 21 Dec 2023
4DMT receives FDA regenerative medicine advanced therapy designation for 4D-150 genetic medicine for intravitreal treatment of wet AMD, the first RMAT designation in wet AMD
21 December 2023 - Designation follows interim Phase 1 PRISM clinical data for 4D-150 that demonstrated an encouraging safety, tolerability and ...
Posted by Michael Wonder on 20 Dec 2023
Ocugen announces OCU400 receives regenerative medicine advanced therapy designation for treatment of retinitis pigmentosa associated with RHO mutations
19 December 2023 - Ocugen today announced that the FDA has granted regenerative medicine advanced therapy designation to Ocugen’s investigational product ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health Phase 3 study results
19 December 2023 - Interim analysis results from first of its kind Phase 3 OUtMATCH study showed Xolair significantly increased the ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21 valent pneumococcal conjugate vaccine specifically designed to protect adults
19 December 2023 - The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in ...
Posted by Michael Wonder on 14 Dec 2023
FDA grants priority review to Amgen's tarlatamab application for advanced small cell lung cancer
13 December 2023 - FDA target action date is 12 June 2024. ...
Posted by Michael Wonder on 07 Dec 2023
Ipsen confirms US FDA grants priority review for new drug application for elafibranor for the treatment of rare cholestatic liver disease, PBC
7 December 2023 - New drug application granted priority review with PDUFA date set for 10 June 2024. ...
Posted by Michael Wonder on 06 Dec 2023
FDA grants priority review of ImmunoGen’s supplemental biologics license application for Elahere (mirvetuximab soravtansine-gynx) in platinum-resistant ovarian cancer
5 December 2023 - Priority review granted with PDUFA date of 5 April 2024. ...
Posted by Michael Wonder on 05 Dec 2023
Osteal Therapeutics’ VT-X7 receives FDA’s breakthrough therapy designation for the treatment of periprosthetic joint infection of the hip and knee
5 December 2023 - The US FDA granted breakthrough therapy designation for VT-X7, Osteal Therapeutics’ investigational drug therapy for periprosthetic joint ...
Posted by Michael Wonder on 05 Dec 2023
US FDA accepts for priority review Bristol Myers Squibb’s application for Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma
5 December 2023 - The US FDA assigned a target action date of 5 April 2024. ...
Posted 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 28 Nov 2023
Sernova receives orphan drug and rare paediatric disease designations for its haemophilia A program from FDA
27 November 2023 - Sernova today announced the US FDA has granted both orphan drug designation and rare paediatric disease designation ...
Posted by Michael Wonder on 14 Nov 2023
Atsena Therapeutics receives FDA regenerative medicine advanced therapy designation for ATSN-101 gene therapy for GUCY2D associated Leber congenital amaurosis
14 November 2023 - ATSN-101 has demonstrated clinically meaningful improvements in vision at the highest dose with no drug-related serious ...
Posted by Michael Wonder on 01 Nov 2023
X4 Pharmaceuticals announces FDA acceptance with priority review of US NDA for mavorixafor in WHIM syndrome
31 October 2023 - FDA sets a PDUFA target action date of 30 April 2024. ...