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RSS FeedPosted by Michael Wonder on 06 Feb 2026
IBSA USA announces FDA approval of Vybrique, the first and only oral film to treat men with erectile dysfunction
5 February 2026 - US commercial availability anticipated in March 2026. ...
Posted by Michael Wonder on 03 Feb 2026
Update on US regulatory review of Saphnelo subcutaneous administration in systemic lupus erythematosus
3 February 2026 - The US FDA issued a complete response letter regarding the biologics license application for Saphnelo (anifrolumab) for ...
Posted by Michael Wonder on 02 Feb 2026
Aquestive Therapeutics announces FDA issuance of complete response letter for Anaphylm
2 February 2026 - Deficiencies limited to packaging and administration. ...
Posted by Michael Wonder on 02 Feb 2026
Pharming Group receives complete response letter from US FDA for sNDA for Joenja (leniolisib) in children aged 4 to 11 years with APDS
1 February 2026 - Pharming today announced that the US FDA has issued a complete response letter to its supplemental ...
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 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
MannKind announces FDA approval of updated Afrezza label providing starting dose guidance when switching from multiple daily injections or insulin pump mealtime therapy
26 January 2026 - Updated initial conversion table based on clinical trials in adults showing significantly improved mealtime glycemic excursions. ...
Posted by Michael Wonder on 23 Jan 2026
Guardant Health receives FDA approval for Guardant360 CDx as companion diagnostic for Braftovi (encorafenib) combination in patients with BRAF V600E mutant metastatic colorectal cancer
22 January 2026 - Approval supported by data from Pfizer’s BREAKWATER trial demonstrating improved outcomes in BRAF V600E-mutant metastatic colorectal cancer ...
Posted by Michael Wonder on 19 Jan 2026
Organon announces US FDA approval of supplemental new drug application extending duration of use of Nexplanon (etonogestrel implant) 68 mg radiopaque
16 January 2026 - Organon announced today that the US FDA has approved a supplemental new drug application for Nexplanon (etonogestrel ...
Posted by Michael Wonder on 12 Jan 2026
FDA approves first treatment for children with Menkes disease
12 January 2026 - The US FDA today approved the Zycubo (copper histidinate) injection as the first treatment for Menkes disease ...
Posted by Michael Wonder on 12 Jan 2026
Atara Biotherapeutics provides regulatory and business update on Ebvallo (tabelecleucel)
12 January 2026 - Atara Biotherapeutics today announced that the US FDA has issued a complete response letter for the ...
Posted by Michael Wonder on 08 Jan 2026
FDA approves new 2 gram presentation of Fibryga, enhancing convenience and precision in treating acquired fibrinogen deficiency
7 January 2026 - Octapharma today announced that the US FDA has approved a new 2 g presentation of Fibryga, fibrinogen ...
Posted by Michael Wonder on 01 Jan 2026
Corcept receives complete response letter for relacorilant as a treatment for patients with hypercortisolism
31 December 2025 - Corcept Therapeutics today announced that the US FDA has issued a complete response letter regarding the ...
Posted by Michael Wonder on 31 Dec 2025
Vanda Pharmaceuticals announces FDA approval of Nereus (tradipitant) for the prevention of vomiting induced by motion: a historic scientific milestone in the prevention of motion sickness
30 December 2025 - Vanda Pharmaceuticals today announced that the US FDA has approved Nereus (tradipitant), an oral neurokinin-1 receptor antagonist, ...
Posted by Michael Wonder on 30 Dec 2025
Unicycive Therapeutics announces resubmission of new drug application for oxylanthanum carbonate
29 December 2025 - New PDUFA date expected in 1H 2026 within 30 days of NDA resubmission. ...