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RSS FeedPosted by Michael Wonder on 01 Feb 2026
Ultragenyx resubmits biologics license application for UX111 AAV gene therapy to treat Sanfilippo syndrome type A (MPS IIIA) to US FDA
30 January 2026 - Company expects up to six month review period per FDA guidelines. ...
Posted by Michael Wonder on 30 Jan 2026
Elevar Therapeutics announces FDA acceptance of new drug application resubmission for rivoceranib in combination with camrelizumab as a first-line systemic treatment for unresectable hepatocellular carcinoma
30 January 2026 - Elevar Therapeutics today announced the US FDA accepted the resubmission of a new drug application for its ...
Posted by Michael Wonder on 29 Jan 2026
QTX-2101 awarded FDA fast track designation for the treatment of acute promyelocytic leukaemia
29 January 2026 - Quetzal Therapeutics announced that the US FDA has granted fast track designation to QTX-2101, the company’s ...
Posted by Michael Wonder on 29 Jan 2026
‘Transformative’ HIV PrEP shot slowly overcomes cost hurdles
28 January 2026 - HIV/AIDS activists heralded the approval of a new twice-yearly pre-exposure prophylaxis (PrEP) medication last year, but ...
Posted by Michael Wonder on 29 Jan 2026
Summit Therapeutics announces US FDA acceptance of biologics license application seeking approval for ivonescimab in combination with chemotherapy in treatment of patients with EGFRm NSCLC post-TKI therapy
29 January 2026 - Summit Therapeutics today announced that the US FDA has accepted for filing Summit's biologics license application seeking ...
Posted by Michael Wonder on 29 Jan 2026
Tenpoint Therapeutics announces FDA approval of Yuvezzi, the first and only combination eye drop approved to treat presbyopia
28 January 2026 - Tenpoint Therapeutics today announced that the US FDA approved Yuvezza (carbachol and brimonidine tartrate ophthalmic solution) ...
Posted by Michael Wonder on 29 Jan 2026
Elevar Therapeutics submits new drug application to FDA for lirafugratinib as second-line treatment option for cholangiocarcinoma
28 January 2026 - Elevar Therapeutics today announced it submitted a new drug application to the US FDA for its investigational ...
Posted by Michael Wonder on 28 Jan 2026
Immix Biopharma receives US FDA breakthrough therapy designation for NXC-201
28 January 2026 - Breakthrough therapy designation granted to NXC-201 based on positive NEXICART-2 Phase 2 interim clinical results, presented at ...
Posted by Michael Wonder on 28 Jan 2026
Biogen’s litifilimab receives FDA breakthrough therapy designation for cutaneous lupus erythematosus, a disease with no targeted treatment options
28 January 2026 - Designation is based on the breadth of available litifilimab data, including the Phase 2 LILAC study result ...
Posted by Michael Wonder on 28 Jan 2026
Otsuka announces FDA acceptance and priority review of new drug application for centanafadine for the treatment of ADHD in children, adolescents, and adults
27 January 2026 - The PDUFA target action date is 24 July 2026. ...
Posted by Michael Wonder on 28 Jan 2026
Novel drug approvals for 2025
23 January 2026 - In 2025, the CDER approved 46 new drugs never before approved or marketed in the US, known ...
Posted by Michael Wonder on 27 Jan 2026
Innovent announces IBI3003 (GPRC5D/BCMA/CD3 trispecific antibody) receives fast track designation from the US FDA for relapsed or refractory multiple myeloma
27 January 2026 - Innovent Biologics announced that its anti-GPRC5D/BCMA/CD3 tri-specific antibody IBI3003 has received fast track designation from the US ...
Posted by Michael Wonder on 27 Jan 2026
Drug Farm announces FDA fast track designation for first in class ALPK1 inhibitor DF-003 for the treatment of ROSAH syndrome
27 January 2026 - Drug Farm today announced that the US FDA has granted fast track designation to DF-003, its investigational, ...
Posted by Michael Wonder on 27 Jan 2026
FDA approves daratumumab and hyaluronidase-fihj with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma
27 January 2026 - Today, the FDA approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) in combination with bortezomib, lenalidomide, ...
Posted by Michael Wonder on 27 Jan 2026
FDA accepts Leqembi Iqlik (lecanemab-irmb) supplemental biologics license application as a subcutaneous starting dose for the treatment of early Alzheimer’s disease under priority peview
26 January 2026 - Eisai and Biogen announced today that the US FDA has accepted for review Eisai’s supplemental biologics license ...