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RSS FeedPosted by Michael Wonder on 17 Feb 2026
FDA approves Rybrevant Faspro (amivantamab and hyaluronidase-lpuj) as the only EGFR-targeted therapy that can be administered once a month
17 February 2026 - Johnson & Johnson today announced the US FDA has approved a new, simplified monthly dosing schedule for ...
Posted by Michael Wonder on 17 Feb 2026
US FDA accepts Bristol Myers Squibb's new drug application for iberdomide in patients with relapsed or refractory multiple myeloma
17 February 2026 - Bristol Myers Squibb today announced that the US FDA has accepted a new drug application for ...
Posted 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12 February 2026 - PTC Therapeutics announced today that it has withdrawn the new drug application resubmission for Translarna (ataluren) ...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
99mTc-maraciclatide granted FDA fast track designation for the visualisation of inflammation in interstitial lung disease
12 February 2026 - Serac Healthcare announced today that the US FDA has granted fast track designation to 99mTc-maraciclatide as ...
Posted by Michael Wonder on 12 Feb 2026
FDA approves labelling changes to menopausal hormone therapy products
12 February 2026 - The US FDA has approved drug labelling changes to six menopausal hormone therapy products, also known as ...
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
FGFR4 inhibitor irpagratinib granted FDA fast track designation for HCC patients
10 February 2026 - Abbisko Therapeutics announced that the US FDA has granted fast track designation to irpagratinib (ABSK-011), a ...
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
FDA intends to take action against non-FDA approved GLP-1 drugs
6 February 2026 - Today, the US FDA is announcing its intent to take decisive steps to restrict GLP-1 active pharmaceutical ...
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 ...