Senate Republican questions FDA chief on counterfeit weight loss drugs
Sen. Jim Banks (R-Ind.) wants the Food and Drug Administration to look into foreign-made active pharmaceutical ingredients he ...
FDA approves first new UTI drug in decades
The Food and Drug Administration (FDA) has approved a new drug for treating urinary tract infections, the first such drug ...
FDA greenlights GSK’s drug for UTIs in women and girls
The FDA approved GSK’s drug for a common type of urinary tract infection (UTI) in women and adolescent girls, one of five new ...
STAT19 小时
Two of FDA’s top cancer regulators to depart, heightening worries about drug reviews
Deputy directors at the FDA center that oversees the regulation of cancer drugs plan to leave, adding to a flood of top ...
International Medication Systems, Ltd. Receives FDA's Drug Shortage Assistance Award
Recognized for contributions to address shortage of epinephrine injection, 0.1 mg/mL syringes RANCHO CUCAMONGA, CA / ACCESS ...
Soleno Therapeutics execs reap stock windfall after FDA approves rare disease drug
Soleno Therapeutics' FDA-approved drug for Prader Willi Syndrome triggers executive stock bonuses as the company's value ...
The Lund Report21 小时
The FDA finally visited an Indian drug factory linked to U.S. deaths. It found problems.
The Food and Drug Administration has found problems at an Indian factory that makes generic drugs for American patients, ...
Liquidia Corporation Announces FDA Acceptance of New Drug Application Resubmission for ...
FDA sets PDUFA goal date of May 24, 2025MORRISVILLE, N.C., March 28, 2025 (GLOBE NEWSWIRE) -- Liquidia Corporation (NASDAQ: LQDA), a biopharmaceutical company developing innovative therapies for ...
FDA approves first at-home, over-the-counter test for STIs. But there's a catch.
The FDA announced Friday that it had approved the first at-home test for sexually transmitted infections, opening the pathway for more to come.
BioSpace3 小时
Milestone Stock Crashes After Surprise Tachycardia Drug Rejection
Milestone Pharmaceuticals hit another bump in the road in its quest to get Cardamyst approved for paroxysmal supraventricular ...
FDA approves new drug to treat protein buildup in the heart
The FDA has approved a new drug for a serious heart condition that affects thousands of people. The drug, called Amvuttra ...
Makary’s FDA Has Options In Industry Fight Over Weight Loss Drugs
Americans pay far more for GLP-1 drugs than citizens in other wealthy nations. If Dr. Marty Makary, the new FDA commissioner, ...