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RSS FeedPosted 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 ...
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 ...
Posted by Michael Wonder on 09 Feb 2026
Sanofi’s rilzabrutinib designated breakthrough therapy in the US and orphan drug in Japan for the treatment of warm autoimmune haemolytic anaemia
9 February 2026 - The US FDA has granted a designation as breakthrough therapy to Wayrilz (rilzabrutinib), a novel oral, ...
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 ...