The FDA will allow a new dosing schedule for Eli Lilly’s Alzheimer’s drug Kisunla that could lessen a known side effect of ...

The U.S. Food and Drug Administration approved changing the prescribing information for Eli Lilly's Alzheimer's drug Kisunla to allow more gradual dosing to lower the risk of a potentially dangerous ...

The Food and Drug Administration (FDA) has approved an updated label for Amyvid (florbetapir F 18 injection) to support Alzheimer disease diagnosis in patients.

Merck's Winrevair gains FDA priority review for PAH label update after ZENITH trial shows major reduction in serious events and strong clinical impact.

After facing an unexpected regulatory delay last month, KalVista Pharmaceuticals has leapt into the commercial realm with the ...

Agency will require a Limitation of Use section in the prescribing information of all extended-release ADHD stimulants.

Welcome to Fierce Pharma's regulatory tracker for the second half of 2025. | In this tracker, Fierce Pharma is recording the ...

The Food and Drug Administration (FDA) has approved Ekterly ® (sebetralstat) for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older.

KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY® (sebetralstat), a novel ...

Click Therapeutics' digital therapeutic (DTx) CT-132 has been approved by the FDA, becoming the first treatment of its type in the US for preventing attacks in people with episodic migraine.

In an editorial in medical journal JAMA, FDA Commissioner Marty Makary and the new director of the Center for Biologics Evaluation and Research (CBER), Vinay Prasad, also said they aim to work ...

Are your “sugar-free” choices really helping you, or quietly sabotaging your goals? With over 43 names for artificial and low ...