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RSS FeedPosted by Michael Wonder on 13 Nov 2025
FDA approves ziftomenib for relapsed or refractory acute myeloid leukaemia with a NPM1 mutation
13 November 2025 - Today, the FDA approved ziftomenib (Komzifti, Kura Oncology), a menin inhibitor, for adults with relapsed or ...
Posted by Michael Wonder on 12 Nov 2025
Parabilis Medicines receives FDA fast track designation for FOG-001, the first and only direct inhibitor of the β-catenin:TCF interaction for the treatment of desmoid tumours
12 November 2025 - Parabilis Medicines today announced that the US FDA has granted fast track product designation to FOG-001 ...
Posted by Michael Wonder on 12 Nov 2025
Artios receives US FDA fast track designation for alnodesertib in ATM negative metastatic colorectal cancer
24 September 2025 - Artios Pharma today announced that the US FDA granted fast track designation to its ATR inhibitor, ...
Posted by Michael Wonder on 12 Nov 2025
March Biosciences receives FDA regenerative medicine advanced therapy designation for MB-105 in relapsed/refractory CD5 positive T-cell lymphoma
11 March 2025 - March Biosciences today announced that the US FDA has granted regenerative medicine advanced therapy designation to ...
Posted by Michael Wonder on 10 Nov 2025
Avenzo Therapeutics granted fast track designation for AVZO-1418, a potential best in class EGFR/HER3 bispecific antibody drug conjugate, for the treatment of patients with EGFR mutated TKI pretreated NSCLC
10 November 2025 - Avenzo Therapeutics today announced the US FDA granted fast track designation to AVZO-1418 (DB-1418), a potential ...
Posted by Michael Wonder on 09 Nov 2025
Mark Cuban Cost Plus Drug Company expands access with addition of Starjemza (ustekinumab-hmny) to give patients more power over prescription costs
6 November 2025 - New biosimilar added to portfolio reinforces the company's commitment to transparency and access ...
Posted by Michael Wonder on 08 Nov 2025
FDA awards second batch of national priority vouchers
6 November 2025 - The US FDA today announced six additional awardees under the Commissioner’s National Priority Voucher pilot program. ...
Posted by Michael Wonder on 08 Nov 2025
Vera Therapeutics submits biologics license application to US FDA through accelerated approval program for atacicept for the treatment of adults with IgA nephropathy
7 November 2025 - Vera Therapeutics today announced it has submitted a biologics license application to the US FDA through ...
Posted by Michael Wonder on 07 Nov 2025
Rhythm Pharmaceuticals announces FDA extension of review period for Imcivree (setmelanotide) for patients with acquired hypothalamic obesity
7 November 2025 - Rhythm Pharmaceuticals today announced that the US FDA has extended by three months the review period for ...
Posted by Michael Wonder on 07 Nov 2025
Mark Cuban is trying to shake up biosimilar pricing with a version of J&J’s best selling Stelara drug
6 November 2025 - By selling at a low price, Cuban hopes to convince health plans, employers to embrace his ...
Posted by Michael Wonder on 07 Nov 2025
The FDA is a mess, but don’t blame it for everything
6 November 2025 - Biohaven and Uniqure fault agency volatility for setbacks. The reality may be more complicated. ...
Posted by Michael Wonder on 06 Nov 2025
FDA approval of Caplyta (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
6 November 2025 - Johnson & Johnson announced today that the US FDA approved Caplyta (lumateperone) as an adjunctive therapy with ...
Posted by Michael Wonder on 06 Nov 2025
FDA approves daratumumab and hyaluronidase-fihj for high-risk smoldering multiple myeloma
6 November 2025 - On November 6, 2025, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (Darzalex Faspro, Janssen Biotech) ...
Posted by Michael Wonder on 05 Nov 2025
Advicenne has submitted to US FDA the registration application for Sibnayal in dRTA treatment
4 November 2025 - Advicenne announces the submission of the registration application for Sibnayal (fixed-dose combination of potassium citrate and ...
Posted by Michael Wonder on 05 Nov 2025
FDA issues complete response letter for Biohaven's Vyglyxia (troriluzole) new drug application for spinocerebellar ataxia
4 November 2025 - Biohaven today announced that it has received a complete response letter from the US FDA for the ...