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 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 ...

More than $7 million in state dollars improved the neighborhood — including a private country club golf course — where Rep. Trey Lamar lives.

HYDERABAD: BRS leader and former minister T Harish Rao on Sunday alleged that Chief Minister A Revanth Reddy misled the ...

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 ...

Twin City Ambulance sent a cease-and-desist letter Friday to the Town of Tonawanda, saying public officials made “false and ...

On September 6, 2024, the United States Securities and Exchange Commission (the SEC) charged Esmark Inc. (“Esmark”) and its Founder/Chairman ...

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 ...

North Carolina families are accusing FEMA and state officials for downplaying Hurricane Helene's damage and death toll. They ...

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 ...

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.

Critics seeks greater regulation of garnet mine operation near state wilderness area; public invited to comment on Barton ...