Tag: FDA

Neural Network Breakthrough: FDA Approves Trials for AI-Created Parkinson’s Drug

January 23, 2026, became a landmark date for digital pharmaceuticals. The U.S. Food and Drug Administration (FDA) issued an...

Good AI Practice: EMA and FDA Establish 10 Global Principles

Global regulators are setting a unified standard for the digital transformation of the pharmaceutical industry. The European Medicines Agency...

Spero Therapeutics plummets 15% as FDA rejects new drug application

Spero Therapeutics , Inc. shares plunged around 15% after-hours following the company’s announcement, according to which the U.S. Food...

FDA investigating another baby death possibly tied to Abbott formula

US Food and Drug Administration officials are investigating the death of another infant who was given formula made by...

Abbott infant formula plant closes again after severe storms and flooding, shares plummet

Abbott Laboratories (ABT.N) has stopped production of the EleCare specialty baby formula at its plant in southwestern Michigan after...

FDA approves Lilly and Incyte’s Olumiant® for alopecia areata

Eli Lilly and Company and Incyte announced  that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib),...

Bluejay Diagnostics shares down 31% after rising Thursday

Bluejay Diagnostics Inc. shares reversed course from Thursday's gains, dropping 31% to $1.12 one day after saying the Food...

Novavax’s COVID-19 vaccine received FDA AdCom approval, clearing “serious hurdles”

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, Tuesday announced the...

Former Eli Lilly employee sues over “serious” manufacturing problems

A former human resources officer at Eli Lilly & Co sued the pharmaceutical company on Monday, alleging she was...

FDA approves Sanofi’s Dupixent for widespread use in the United States

Sanofi won expanded U.S. approval for its best-selling Dupixent injection to treat an allergic inflammation of the esophagus, the...

U.S.FDA lifts ban on COVAXIN Covid-19 vaccine candidate study

Ocugen, Inc., a biotechnology company focused on discovering, developing, and commercializing novel gene therapies, biologicals, and vaccines, May 23th...

Abbott caused the baby formula crisis, but who will be held responsible

U.S. Secretary of Transportation Pete Buttigieg on Sunday blamed the worsening baby formula shortage on Abbott Nutrition, one of...