Zealand Pharma Gets FDA Complete Response Letter for Hypoglycemia New Drug Application
Zealand Pharma said it has received a complete response letter from the Food and Drug Administration related to its new drug application for dasiglucagon for the prevention and treatment of ...
FierceBiotech21d
Vanda receives FDA rejection, issues fiery response against ‘conclusory’ refusal
The biotech came out swinging after the knock-back, accusing the agency of sending a complete response letter that generally disregarded the evidence. Vanda CEO Mihael Polymeropoulos, M.D., had ...
pharmaphorum6y
FDA rejects Pharming's Ruconest HAE label expansion
The FDA asked Pharming to carry out an additional trial in its Complete Response Letter (CRL) rejecting the company’s filing to expand Ruconest's label to include its use as a prophylactic ...
pharmaphorum1y
FDA won’t approve Lilly’s mirikizumab for ulcerative colitis
The FDA has issued a complete response letter to Eli Lilly, turning down its attempt to get approval for anti-IL-23p19 antibody mirikizumab as a treatment for ulcerative colitis (UC). The company ...
FiercePharma24d
Lilly's immunology unit scores another FDA nod with eczema treatment Ebglyss
The agency’s complete response letter (CRL) did not raise any issues with lebrikizumab’s clinical data package, label or safety. Earlier this year, Japan and Canada signed off on Ebglyss.
FiercePharma29d
After FDA rejection, Sanofi and Regeneron show data that could pave way for Dupixent to treat hives condition
The result helped convince the FDA to reject Sanofi and Regeneron’s application for approval and ask the companies in a complete response letter for more efficacy data. More than 300,000 people ...
FierceBiotech23d
Ascendis' dwarfism drug accelerates growth in phase 3, teeing up challenge to BioMarin
The biotech ran into problems when applying for approval of its hypoparathyroidism drug, receiving a complete response letter and facing a three-month delay when it refiled, but Mikkelsen said the ...
Benzinga.com1y
FDA Calendar
The verdict can be an ‘approved’ decision, or a ‘complete response letter’ or a delay due to reasons specific to the company or extraneous to the company. PDUFA was passed in the U.S. in ...
False claims about the federal response to Helene are an ominous sign for the coming election
False claims about the federal response to the historic devastation left by Hurricane Helene are spreading out of control on ...
Powerful lawmaker helped steer millions in state dollars for his neighborhood, golf course
House Ways and Means Chairman Trey Lamar has helped steer more than $7 million in state money to improve the affluent country ...
D.C. audit of police ranks for links to white supremacy nears completion
Officers at the Jan. 6 riot, and a D.C. lieutenant supporting the Proud Boys, led council to call for audit of D.C. police.
How a Zuckerberg letter got Trump to accuse himself of rigging 2020
Also again, the response to that story was not demonstrably a factor in the election outcome. The last point in Zuckerberg’s ...