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RSS FeedPosted by Michael Wonder on 26 Dec 2023
US Food and Drug Administration issues complete response letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility
23 December 2023 - The CRL is related to deficiencies identified at a third-party manufacturing facility following an inspection but are ...
Posted by Michael Wonder on 23 Dec 2023
Patritumab deruxtecan granted priority review in the US for certain patients with previously treated locally advanced or metastatic EGFR mutated non-small-cell lung cancer
22 December 2023 - Submission based on HERTHENA-Lung01 results showing patritumab deruxtecan demonstrated clinically meaningful and durable responses in patients ...
Posted by Michael Wonder on 23 Dec 2023
Sarepta Therapeutics submits efficacy supplement to expand the Elevidys label to include Duchenne muscular dystrophy patients without restriction to age or ambulatory status
22 December 2023 - Sarepta has also submitted the EMBARK post-marketing requirement to the FDA seeking conversion of the Elevidys accelerated ...
Posted by Michael Wonder on 23 Dec 2023
Zealand Pharma submits new drug application to the US FDA for glepaglutide in short bowel syndrome
22 December 2023 - Zealand Pharma today announced the submission of a new drug application to the US FDA for glepaglutide, ...
Posted by Michael Wonder on 21 Dec 2023
Johnson & Johnson submits supplemental biologics license application and new drug application to US FDA seeking approval of Rybrevant (amivantamab-vmjw) plus lazertinib for the treatment of patients with EGFR mutated non-small-cell lung cancer
21 December 2023 - Submissions supported by data from landmark Phase 3 MARIPOSA study, which showed statistically significant and clinically meaningful ...
Posted by Michael Wonder on 21 Dec 2023
Merck provides US regulatory update on gefapixant
21 December 2023 - Merck today announced that the US FDA has issued a complete response letter regarding Merck’s new drug ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Xolair (omalizumab) for children and adults with food allergies based on positive National Institutes of Health Phase 3 study results
19 December 2023 - Interim analysis results from first of its kind Phase 3 OUtMATCH study showed Xolair significantly increased the ...
Posted by Michael Wonder on 20 Dec 2023
FDA grants priority review to Merck’s new biologics license application for V116, an investigational, 21 valent pneumococcal conjugate vaccine specifically designed to protect adults
19 December 2023 - The 21 serotypes covered by V116 are responsible for approximately 83% of invasive pneumococcal disease in ...
Posted by Michael Wonder on 18 Dec 2023
Telix submits biologics license application for TLX250-CDx (Zircaix) for imaging of kidney cancer
19 December 2023 - Telix today announces that it has submitted its biologics license application to the United States US FDA ...
Posted by Michael Wonder on 18 Dec 2023
US FDA issues complete response letter for cosibelimab solely due to inspection findings at third party manufacturer
18 December 2023 - FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability ...
Posted by Michael Wonder on 15 Dec 2023
CymaBay submits new drug application to FDA for seladelpar for the treatment of primary biliary cholangitis
15 December 2023 - New drug application is supported by data evaluating seladelpar efficacy and safety in over 500 patients. ...
Posted by Michael Wonder on 15 Dec 2023
CSL's garadacimab, a first in class factor XIIa inhibitor, receives FDA and EMA filing acceptance
14 December 2023 - These regulatory milestones bring CSL one step closer to delivering on our promise to patients with ...
Posted by Michael Wonder on 14 Dec 2023
FDA grants priority review to Amgen's tarlatamab application for advanced small cell lung cancer
13 December 2023 - FDA target action date is 12 June 2024. ...
Posted by Michael Wonder on 13 Dec 2023
MAPS PBC announces submission of new drug application to the FDA for MDMA assisted therapy for PTSD
12 December 2023 - Filing marks first NDA submission for any psychedelic-assisted therapy. ...
Posted by Michael Wonder on 12 Dec 2023
Humacyte submits biologics license application to US FDA seeking approval of human acellular vessel for the treatment of vascular trauma
12 December 2023 - BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the human ...