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RSS FeedPosted by Michael Wonder on 16 Jul 2024
Sumitomo Pharma announces that DSP-5336 has received FDA fast track designation for the treatment of relapsed or refractory acute myeloid leukaemia
15 July 2024 - -- Sumitomo Pharma today announced that the US FDA granted fast track designation to DSP-5336 for ...
Posted by Michael Wonder on 15 Jul 2024
Onco360 selected as a limited distribution specialty pharmacy partner for Rytelo (imetelstat)
12 July 2024 - Onco360 has been selected as a pharmacy partner by Geron Corporation for Rytelo (imetelstat) as a ...
Posted by Michael Wonder on 13 Jul 2024
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in giant cell arteritis
12 July 2024 - Submissions are supported by the Phase 3 SELECT-GCA study demonstrating upadacitinib 15 mg with a 26 week ...
Posted by Michael Wonder on 13 Jul 2024
FDA grants fast track designation to 9MW2821 for the treatment of patients with locally advanced or metastatic nectin-4 positive TNBC
12 July 2024 - Mabwell announces that its self-developed novel nectin-4-targeting ADC (9MW2821) has been granted fast track designation by the ...
Posted by Michael Wonder on 12 Jul 2024
Incorporating real option value in valuing innovation: a way forward
10 July 2024 - Considerable progress has been made in defining and measuring the real option value of medical technologies. ...
Posted by Michael Wonder on 12 Jul 2024
AskBio receives FDA fast track and MHRA Innovation Passport designations for AB-1005 investigational GDNF gene therapy for Parkinson’s disease
11 July 2024 - Bayer AG and Asklepios BioPharmaceutical today announced that the US FDA has granted fast track designation ...
Posted by Michael Wonder on 11 Jul 2024
Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec
10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the ...
Posted by Michael Wonder on 10 Jul 2024
Obsidian Therapeutics announces FDA fast track designation for OBX-115 for the treatment of advanced melanoma
9 July 2024 - Obsidian Therapeutics today announced that the US FDA has granted fast track designation to OBX-115, a ...
Posted by Michael Wonder on 09 Jul 2024
FDA approves Arcutis’ Zorvye (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age
9 July 2024 - Commercial product expected to be available by the end of July. ...
Posted by Michael Wonder on 07 Jul 2024
FDA approves Genentech’s Vabysmo pre-filled syringe for three leading causes of vision loss
4 July 2024 - Vabysmo PFS is the first and only syringe pre-filled with an FDA approved bi-specific antibody to treat ...
Posted by Michael Wonder on 06 Jul 2024
Four decades of orphan drugs and priorities for the future
6 July 2024 - The Orphan Drug Act was enacted in the United States in 1983 in response to growing awareness ...
Posted by Michael Wonder on 05 Jul 2024
Hinova Pharmaceuticals receives FDA fast track designation for HP518 for treatment of androgen receptor triple-negative breast cancer
5 July 2024 - Hinova Pharmaceuticals today announced that the US FDA has granted fast track designation for HP518, an investigational ...
Posted by Michael Wonder on 04 Jul 2024
Checkpoint Therapeutics announces biologics license application resubmission for cosibelimab
2 July 2024 - Checkpoint Therapeutics today announced it has completed the resubmission of its biologics license application to the US ...
Posted by Michael Wonder on 04 Jul 2024
Full-Life Technologies granted FDA fast track designation for 225Ac-FL-020 for the treatment of metastatic castration resistant prostate cancer
2 July 2024 - Full-Life Technologies today announced that the US FDA has granted fast track designation for 225Ac-FL-020, the company's ...
Posted by Michael Wonder on 03 Jul 2024
Johnson & Johnson receives approval from US FDA and European Commission for Sirturo (bedaquiline)
2 July 2024 - Johnson & Johnson announced today that the US FDA has issued traditional approval for Sirturo (bedaquiline) ...