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RSS FeedPosted by Michael Wonder on 18 Feb 2026
Sandoz receives US FDA approval to expand Enzeevu (aflibercept-abzv) label for multiple retinal indications
18 February 2026 - Sandoz today announced that the US FDA has approved an expanded label for Enzeevu (aflibercept-abzv), to include ...
Posted by Michael Wonder on 18 Feb 2026
Deciphera Pharmaceuticals announces US FDA acceptance for filing of new drug application for tirabrutinib in patients with relapsed or refractory PCNSL
17 February 2026 - Deciphera Pharmaceuticals today announced that the US FDA has accepted for filing the new drug application under ...
Posted by Michael Wonder on 17 Feb 2026
Acrotech Biopharma announces FDA approval of Adquey (difamilast 1%) ointment for the treatment of mild to moderate atopic dermatitis
13 February 2026 - Acrotech Biopharma, in collaboration with Otsuka, today announces that the US FDA has approved the new ...
Posted 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12 February 2026 - PTC Therapeutics announced today that it has withdrawn the new drug application resubmission for Translarna (ataluren) ...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 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
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 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 09 Feb 2026
Krystal Biotech announces RMAT designation granted by FDA to KB707 for the treatment of advanced or metastatic non-small cell lung cancer
9 February 2026 - Krystal Biotech announced today that the US FDA granted regenerative medicine advanced therapy designation to KB707, ...
Posted by Michael Wonder on 09 Feb 2026
ICER releases evidence report on therapies for IgA nephropathy
9 February 2026 - All three therapies exhibit net health benefits, but uncertainties remain around the magnitude of long-term improvements ...