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RSS FeedPosted by Michael Wonder on 03 Aug 2023
Aardvark Therapeutics announces receipt of FDA rare paediatric disease designation for Prader-Willi syndrome
3 August 2023 - Aardvark's Phase 2 trial of oral ARD-101 in young adults with Prader-Willi syndrome is now open ...
Posted by Michael Wonder on 03 Aug 2023
US FDA approves Merck’s Ervebo (Ebola Zaire vaccine, live) for use in children 12 months of age and older
3 August 2023 - Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease. ...
Posted by Michael Wonder on 02 Aug 2023
FDA approves trifluridine and tipiracil with bevacizumab for previously treated metastatic colorectal cancer
2 August 2023 - Today, the FDA approved trifluridine and tipiracil (Lonsurf, Taiho Oncology) with bevacizumab, for metastatic colorectal cancer ...
Posted by Michael Wonder on 02 Aug 2023
PYC Therapeutics gets fast track status from FDA for retinitis pigmentosa treatment
1 August 2023 - PYC Therapeutics has received fast track designation from the US FDA for a new drug aimed ...
Posted by Michael Wonder on 02 Aug 2023
Changes in the number of continuation patents on drugs approved by the FDA
1 August 2023 - Brand name pharmaceutical manufacturers often sustain high prices in the US by obtaining patents that delay generic ...
Posted by Michael Wonder on 01 Aug 2023
FDA grants QIDP designation for Kinnear's CSA-131 drug for life-threatening Pseudomonas bacterial infections in CF
31 July 2023 - Kinnear Pharmaceuticals today announced the US FDA has granted qualified infectious disease product designation for CSA-131 ...
Posted by Michael Wonder on 01 Aug 2023
Stakeholders want clearer terms in FDA's generally accepted scientific knowledge guidance
31 July 2023 - Drug makers and research groups are generally supportive of the US FDA’s plan to allow greater flexibility ...
Posted by Michael Wonder on 31 Jul 2023
FDA approves dostarlimab-gxly with chemotherapy for endometrial cancer
31 July 2023 - Today, the FDA approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for ...
Posted by Michael Wonder on 31 Jul 2023
FDA grants fast track designation to IVS-3001, a CAR-T cell therapy in the treatment of renal cell carcinoma
31 July 2023 - Invectys is pleased to announce the US FDA has granted fast track designation to its revolutionary ...
Posted by Michael Wonder on 31 Jul 2023
US FDA accepts biologics license application for GC Biopharma's GC5107B (immune globulin intravenous (human), 10% liquid)
31 July 2023 - GC Biopharma today announced that the US FDA has accepted the Company's resubmission of the biologics ...
Posted by Michael Wonder on 30 Jul 2023
Citius Pharmaceuticals receives a complete response letter from the US FDA for Lymphir (denileukin diftitox) for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma
29 July 2023 - No clinical efficacy or safety issues raised. ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 28 Jul 2023
CDER collaborates with global regulators on pharmaceutical quality assessments and inspections
28 July 2023 - The FDA and the EMA recently completed the first collaborative assessment of a proposed post-approval change ...
Posted by Michael Wonder on 28 Jul 2023
FDA approves second over the counter naloxone nasal spray product
28 July 2023 - Today, the US FDA approved RiVive, 3 mg naloxone hydrochloride nasal spray for over the counter, non-prescription ...
Posted by Michael Wonder on 27 Jul 2023
FDA grants breakthrough therapy designation to NS-089/NCNP-02 for the treatment of Duchenne muscular dystrophy
27 July 2023 - NS Pharma announced today the US FDA has granted breakthrough therapy designation to NS-089/NCNP-02, an investigational ...