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 ...

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 ...

Swiss pharma giant Roche has announced positive top-line results from the Phase III REGENCY study of Gazyva/Gazyvaro ...

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 ...

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 ...

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 ...

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 ...

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 ...

"Our findings yield a prison system in crisis. Most disturbingly, our findings show that the men and women in our state ...