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RSS FeedPosted by Michael Wonder on 19 Jul 2026
US FDA accepts Bristol Myers Squibb's new drug application for mezigdomide in patients with relapsed or refractory multiple myeloma
13 July 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...
Posted by Michael Wonder on 19 Jul 2026
US FDA accepts BioMarin’s supplemental new drug application for full approval of Voxzogo (vosoritide) for children with achondroplasia
13 July 2026 - BioMarin today announced that the US FDA has accepted the company's supplemental new drug application for Voxzogo ...
Posted by Michael Wonder on 19 Jul 2026
FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
14 July 2026 - Today, the FDA granted traditional approval to selpercatinib (Retevmo, Eli Lilly) for adult and pediatric patients ...
Posted by Michael Wonder on 18 Jul 2026
FDA accepts Shionogi’s sNDA for Fetroja (cefiderocol) for use in pediatric patients with serious infections caused by susceptible gram negative bacteria submission intends to address a critical therapeutic gap for vulnerable young patients facing drug-resistant pathogens
17 July 2026 - Shionogi announced the US FDA has accepted a Supplemental new drug application for Fetroja (cefiderocol) for ...
Posted by Michael Wonder on 17 Jul 2026
FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR positive, HER2 negative locally advanced or metastatic breast cancer
14 July 2026 - Today, the FDA approved gedatolisib (Revtorpyk, Celcuity) in combination with fulvestrant, with or without palbociclib, for ...
Posted by Michael Wonder on 17 Jul 2026
FDA grants priority review to Genentech’s Gazyva for adults with primary membranous nephropathy
14 July 2026 - Genentech announced today that the US FDA has granted priority review to the company’s supplemental biologics license ...
Posted by Michael Wonder on 17 Jul 2026
Apnimed announces FDA acceptance of new drug application for AD109, an investigational oral pill to treat adults with obstructive sleep apnoea
14 July 2026 - Apnimed today announced that the US FDA has accepted for review the new drug application filing of ...
Posted by Michael Wonder on 17 Jul 2026
Novartis Fabhalta (iptacopan) receives FDA traditional approval as first and only complement inhibitor to significantly slow kidney function decline in primary IgAN
17 July 2026 - Novartis today announced that the US FDA has granted traditional approval for Fabhalta (iptacopan) to slow kidney ...
Posted by Michael Wonder on 17 Jul 2026
Camurus' NDA resubmission for CAM2029 in acromegaly accepted for review by the US FDA
17 July 2026 - Camurus today announced that the US FDA has accepted for review the resubmission of the new drug ...
Posted by Michael Wonder on 17 Jul 2026
FDA approves first oral therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) to lower bad cholesterol in adults with high cholesterol
16 July 2026 - FDA has approved Lipfendra (enlicitide) as a treatment to be used with diet and exercise, to ...
Posted by Michael Wonder on 15 Jul 2026
FDA approves Leqembi Iqlik (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer's disease
13 July 2026 - BioArctic's partner Eisai today announced that the US FDA has approved a supplemental biologics license application for ...
Posted by Michael Wonder on 12 Jul 2026
Nicox’s NCX 470 new drug application submitted in the United States by Kowa
1 July 2026 - Submission based on positive results from two Phase 3 clinical trials, Mont Blanc and Denali. ...
Posted by Michael Wonder on 12 Jul 2026
Organogenesis announces FDA acceptance of biologics license application for ReNu for the management of symptomatic knee osteoarthritis
6 July 2026 - Organogenesis today announced that the US FDA has completed their filing determination and accepted for review the ...
Posted by Michael Wonder on 12 Jul 2026
Pharvaris announces FDA acceptance of new drug application for deucrictibant IR for on-demand treatment of hereditary angioedema attacks
6 July 2026 - Pharvaris today announced that the US FDA has accepted its new drug application for deucrictibant immediate ...
Posted by Michael Wonder on 11 Jul 2026
Elevar Therapeutics receives FDA complete response letter for combination of rivoceranib and camrelizumab as a first-line treatment for unresectable or metastatic hepatocellular carcinoma
10 July 2026 - Elevar Therapeutics today announced that the US FDA issued a complete response lette regarding its new ...