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RSS FeedPosted by Michael Wonder on 13 Feb 2026
Disc Medicine receives complete response letter from FDA for bitopertin for the treatment of EPP
13 February 2026 - Disc Medicine announced that the US FDA today issued a complete response letter for the new drug ...
Posted by Michael Wonder on 13 Feb 2026
PTC Therapeutics provides regulatory update on Translarna
12 February 2026 - PTC Therapeutics announced today that it has withdrawn the new drug application resubmission for Translarna (ataluren) ...
Posted by Michael Wonder on 13 Feb 2026
Agilent receives FDA approval for PD-L1 IHC 22C3 pharmDx in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
11 February 2026 - Approval expands PD-L1 testing to support treatment decisions with Keytruda (pembrolizumab). ...
Posted by Michael Wonder on 12 Feb 2026
FDA refusing to review Moderna mRNA flu shot application
11 February 2026 - Moderna said on Tuesday that the FDA has refused to review its application for an mRNA flu ...
Posted by Michael Wonder on 12 Feb 2026
Price, therapeutic value impact international submission times for new drugs
11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...
Posted by Michael Wonder on 11 Feb 2026
Moderna receives refusal to file letter from the US FDA for its investigational seasonal influenza vaccine, mRNA-1010
10 February 2026 - Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
Posted by Michael Wonder on 10 Feb 2026
FDA approves pembrolizumab with paclitaxel for platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma
10 February 2026 - Today, the FDA approved pembrolizumab (Keytruda, Merck) as well as pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, ...
Posted by Michael Wonder on 10 Feb 2026
US FDA accepts new drug application and grants priority review for Takeda’s oveporexton (TAK-861) as a potential first in class therapy for narcolepsy type 1
10 February 2026 - Takeda today announced that the US FDA accepted its new drug application and granted priority review for ...
Posted by Michael Wonder on 10 Feb 2026
RegenxBio announces regulatory update on RGX-121 BLA for MPS II
9 February 2026 - RegenXBio today announced that the US FDA has issued a complete response letter regarding its biologics ...
Posted by Michael Wonder on 08 Feb 2026
FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma
6 February 2026 - FDA approves label update for Kite’s Yescarta for relapsed/refractory primary central nervous system lymphoma. ...
Posted by Michael Wonder on 06 Feb 2026
FDA grants priority review for Hympavzi (marstacimab) sBLA for the treatment of two haemophilia A or B patient populations with significant medical need
6 February 2026 - Pfizer today announced that the US FDA has accepted and granted priority review for the company’s ...
Posted 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 04 Feb 2026
AbbVie submits regulatory applications to FDA and EMA for upadacitinib (Rinvoq) in adults and adolescents with vitiligo
3 February 2026 - Submissions are supported by data from the Phase 3 Viti-Up clinical studies demonstrating upadacitinib achieved the co-primary ...
Posted by Michael Wonder on 04 Feb 2026
OS Therapies initiates US FDA BLA filing for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma
2 February 2026 - OS Therapies today announced that it has formally initiated a biologics license application submission to the US ...
Posted by Michael Wonder on 03 Feb 2026
Exelixis announces US FDA accepted the new drug application for zanzalintinib in combination with an immune checkpoint inhibitor for patients with metastatic colorectal cancer
2 February 2026 - Exelixis today announced that its new drug application for zanzalintinib, in combination with atezolizumab (Tecentriq), has ...