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RSS FeedPosted by Michael Wonder on 26 Aug 2024
BeiGene’s BGB-16673 receives US FDA fast track designation for CLL/SLL
26 August 2024 - Designation supported by promising safety and efficacy data from Phase 1/2 study in heavily pretreated patients with ...
Posted by Michael Wonder on 25 Aug 2024
FDA grants fast track designation to Aveta Biomics’ drug APG-157 for neo-adjuvant treatment of head and neck cancer
22 August 2024 - Aveta Biomics is pleased to announce that the US FDA has granted fast track designation to APG-157, ...
Posted by Michael Wonder on 21 Aug 2024
Bristol Myers Squibb receives US Food and Drug Administration sBLA acceptance for first-line treatment of unresectable hepatocellular carcinoma
21 August 2024 - The US FDA assigned a target action date of 21 April 2025. ...
Posted by Michael Wonder on 21 Aug 2024
US FDA grants tentative approval of Yutrepia (treprostinil) inhalation powder for patients with pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease
19 August 2024 - Final approval of Yutrepia for pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease may occur ...
Posted by Michael Wonder on 21 Aug 2024
Regeneron provides update on biologics license application for linvoseltamab
20 August 2024 - Regeneron Pharmaceuticals today announced that the US FDA has issued a complete response letter for the biologics ...
Posted by Michael Wonder on 20 Aug 2024
GSK receives US FDA breakthrough therapy designation for its B7-H3 targeted antibody-drug conjugate in relapsed or refractory extensive-stage small-cell lung cancer
20 August 2024 - Regulatory designation based on promising early clinical evidence observed with GSK5764227 in this tumour type. ...
Posted by Michael Wonder on 20 Aug 2024
FDA approves lazertinib with amivantamab-vmjw for non-small lung cancer
20 August 2024 - On August 19, 2024, the FDA approved lazertinib (Lazcluze, Janssen Biotech) in combination with amivantamab-vmjw (Rybrevant, Janssen ...
Posted by Michael Wonder on 20 Aug 2024
ReAlta Life Sciences granted FDA orphan drug designation and fast track designation for RLS-0071 for the treatment of steroid-refractory acute graft versus host disease
19 August 2024 - Second clinical indication for RLS-0071 to receive both orphan drug designation and fast track designation, demonstrating the ...
Posted by Michael Wonder on 20 Aug 2024
Arthrosi Therapeutics receives FDA fast track designation for AR882 in tophaceous gout
19 August 2024 - Arthrosi Therapeutics today announced the US FDA has granted fast track designation to AR882 for the potential ...
Posted by Michael Wonder on 19 Aug 2024
Enhertu granted breakthrough therapy designation in US for certain patients with HER2 low or HER2 ultralow metastatic breast cancer
19 August 2024 - Daiichi Sankyo and AstraZeneca's Enhertu has now been granted eight breakthrough therapy designations with latest based ...
Posted by Michael Wonder on 16 Aug 2024
US FDA accepts for priority review Deciphera’s new drug application for vimseltinib for the treatment of patients with tenosynovial giant cell tumour
15 August 2024 - The US FDA has assigned a target action date of 17 February 2025. ...
Posted by Michael Wonder on 15 Aug 2024
FDA approves neo-adjuvant/adjuvant durvalumab for resectable non-small cell lung cancer
15 August 2024 - Today, the FDA approved durvalumab (Imfinzi, AstraZeneca) with platinum-containing chemotherapy as neo-adjuvant treatment, followed by single-agent ...
Posted by Michael Wonder on 15 Aug 2024
Accutar Biotechnology receives FDA fast track designation for AC699 in ER positive, HER2 negative breast cancer
14 August 2024 - Accutar Biotechnology announced today that the US FDA has granted the investigation of AC699 a fast track ...
Posted by Michael Wonder on 15 Aug 2024
Imfinzi granted priority review and breakthrough therapy designation for patients with limited-stage small cell lung cancer in the US
15 August 2024 - Based on ADRIATIC Phase 3 trial which demonstrated statistically significant and clinically meaningful overall survival and ...
Posted by Michael Wonder on 15 Aug 2024
Kiromic BioPharma’s Deltacel receives FDA fast track designation
14 August 2024 - Kiromic BioPharma announces that the US FDA has granted fast track designation to Deltacel (KB-GDT-01), the Company’s ...