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RSS FeedPosted by Michael Wonder on 29 Aug 2024
FDA grants priority review to SpringWorks Therapeutics’ new drug application for mirdametinib for the treatment of adults and children with neurofibromatosis type 1-associated plexiform neurofibromas
28 August 2024 - PDUFA target action date of 28 February 2025. ...
Posted by Michael Wonder on 29 Aug 2024
Life Molecular Imaging receives FDA fast track designation for [18F]PI-2620 in Tau PET imaging across three neurodegenerative conditions
28 August 2024 - Life Molecular Imaging is pleased to announce that the US FDA granted fast track designation to [18F]PI-2620 ...
Posted by Michael Wonder on 28 Aug 2024
Telix submits NDA for TLX101-CDx (Pixclara) brain cancer imaging agent
28 August 2024 - Telix today announces it has submitted a new drug application to the US FDA for TLX101-CDx, (Pixclara, ...
Posted by Michael Wonder on 28 Aug 2024
Lilly releases Zepbound (tirzepatide) single-dose vials, expanding supply and access for adults living with obesity
27 August 2024 - Eli Lilly today announced Zepbound (tirzepatide) 2.5 mg and 5 mg single-dose vials are available for self-pay ...
Posted by Michael Wonder on 27 Aug 2024
Soleno Therapeutics announces US FDA acceptance for filing and priority review of NDA for DCCR (diazoxide choline) extended release tablets in Prader-Willi syndrome
27 August 2024 - Soleno Therapeutics today announced that the US FDA has accepted for filing its new drug application ...
Posted by Michael Wonder on 27 Aug 2024
FDA grants fast track designation for bexmarilimab
26 August 2024 - Faron Pharmaceuticals today announces that their lead candidate bexmarilimab has been granted fast track designation for the ...
Posted by Michael Wonder on 27 Aug 2024
Rhythm Pharmaceuticals announces FDA acceptance for priority review of supplemental new drug application for Imcivree (setmelanotide) in patients as young as 2 years old
26 August 2024 - FDA sets PDUFA goal date of 26 December 2024. ...
Posted 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 26 Aug 2024
FDA clears first device to enable automated insulin dosing for individuals with type 2 diabetes
26 August 2024 - Agency supports broader access to innovative technology in diabetes management. ...
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 25 Aug 2024
Abata Therapeutics receives FDA fast track designation for ABA-101 for the treatment of progressive multiple sclerosis
22 August 2024 - Abata Therapeutics today announced that the US FDA has granted fast track designation for ABA-101 for the ...
Posted by Michael Wonder on 22 Aug 2024
Opus Genetics receives rare paediatric disease designation from the US FDA for ocular gene therapy OPGx-LCA5 to treat rare inherited retinal disease LCA5
20 August 2024 - Opus Genetics today announced the US FDA has granted rare paediatric disease designation for its ocular gene ...
Posted by Michael Wonder on 22 Aug 2024
FDA approves and authorises updated mRNA COVID-19 vaccines to better protect against currently circulating variants
22 August 2024 - Today, the US FDA approved and granted emergency use authorisation for updated mRNA COVID-19 vaccines (2024-2025 formula) ...
Posted by Michael Wonder on 22 Aug 2024
Clarity receives FDA fast track designation for 64Cu-SAR-bisPSMA
22 August 2024 - Clarity Pharmaceuticals is pleased to announce that the US FDA has granted fast track designation for 64Cu-SAR-bisPSMA ...
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. ...