News

FDA delays approval decision for Bayer menopause therapy
The agency told Bayer it needs additional time to review the non-hormonal drug, called elinzanetant. Regulators in Canada and the U.K. have already cleared it for use.
The Manila Times1d
FDA Approves SKYTROFA® (Lonapegsomatropin-tcgd) for the Once-Weekly Treatment of Adults with Growth Hormone Deficiency
First of many planned label expansions supporting Vision 2030 goal to become the leading endocrinology rare disease companyOn track to initiate basket trial for ISS, SHOX deficiency, Turner syndrome, ...
Sarepta will resume gene therapy shipments after FDA review of recent patient death
Shares of drugmaker Sarepta Therapeutics surged in afterhours trading Monday after the company said it would resume shipping ...
Avant Technologies and Ainnova Tech Advance Clinical Trial Protocol Following FDA Feedback
Avant Technologies Inc. (OTCQB: AVAI) ("Avant" or the "Company"), an emerging technology company developing healthcare solutions, and its Joint Venture partner, Ainnova Tech, Inc. (Ainnova), a leading ...
RedHill Receives Positive FDA Feedback on Pathway to Approval of Groundbreaking RHB-204 for Crohn's Disease
RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that it received positive feedback from the U.S. Food and Drug Administration ...
Biocon Biologics Expands Diabetes Portfolio With FDA Approval Of Kirstytm, The First And Only Interchangeable Rapid-Acting Insulin Aspart In The United States
BRIDGEWATER, N.J., United States and BENGALURU, Karnataka, India, July 15, 2025 (GLOBE NEWSWIRE) -- Biocon Biologics Ltd (BBL) , a fully int ...
Apellis wins FDA label expansion for Empaveli in rare kidney disorders
Apellis Pharma (APLS) stock in focus as the FDA expands the label for its injectable therapy Empaveli to treat rare kidney ...
STAT16h
How the FDA can score quick wins on transparency
Improving how the FDA disseminates already-public information about approved drugs may be unsexy, but it would be a big step ...
Futurism on MSN5d
The FDA Is Using an AI to "Speed Up" Drug Approvals and Insiders Say It's Making Horrible Mistakes
Insiders at the Food and Drug Administration are ringing alarm bells over the agency's use of an AI to fast-track drug ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...
Food Engineering15d
FDA Approves Gardenia Blue Color Additive
Gardenia blue is the fourth color derived from natural sources approved by the FDA for use in foods as part of its aim to phase out the use of petroleum-based dyes.