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 ...
Denmark's Zealand provides US FDA update on drug for low blood sugar in infants
Denmark's Zealand Pharma said on Tuesday the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) relating to its drug for preventing and treating low blood sugar in ...
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.
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Powerful lawmaker helped steer millions in state dollars for his neighborhood, golf course
More than $7 million in state dollars improved the neighborhood — including a private country club golf course — where Rep. Trey Lamar lives.
Telangana CM Revanth Reddy misled entire nation on crop loan waiver: BRS leader Harish Rao
HYDERABAD: BRS leader and former minister T Harish Rao on Sunday alleged that Chief Minister A Revanth Reddy misled the ...
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In sustained rare disease push, Recordati lays out $825M upfront to acquire Sanofi's CAD drug Enjaymo
Still, the path to approval for Enjaymo wasn’t easy, with the med receiving a complete response letter in November of 2020 after the FDA uncovered deficiencies during an inspection of a contract ...
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Buying Opportunities In Biotech And Pharma With Bhavneesh Sharma
Kirk Spano and Bhavneesh Sharma talk biotech, pharma, the unpredictable FDA and why complete response letters are ... to investors that read my investment letter or my clients at my investment ...
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Recent Enforcement Action Serves as Reminder of SEC’s Active Enforcement of Tender Offer Rules
On September 6, 2024, the United States Securities and Exchange Commission (the SEC) charged Esmark Inc. (“Esmark”) and its Founder/Chairman ...
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FDA knocks back Takeda's blockbuster hope TAK-721
Takeda said it had received a complete response letter from the US regulator that is asking for another clinical trial of the drug, which could set back the timeline for the programme considerably.
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FDA blocks new use for AstraZeneca's Ultomiris
In a complete response letter (CRL), the FDA said it was not asking for any additional clinical data for Ultomiris as a treatment for NMOSD, but is looking for modifications to the risk evaluation ...
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Gas Leaks, Explosions Intensify Discussion about D.C.’s Clean Energy Future
Gas leaks and explosions have intensified calls among environmentalists for the District and utility companies to embrace ...
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Israel strikes Lebanon as region braces for response to Iran
This response has failed to satisfy French and international NGOs, including Amnesty International, whose French chief Jean-Claude Samouillier penned an open letter to Macron earlier this year ...