The Latest Breaking News from FDA

Urgent recall of croutons sold at Kroger over health risk

Affected products were sold at the grocery chain’s stores in 17 states

The Independent UK · May 19

Agios Pharmaceuticals Touts Strong AQVESME Launch as Sickle Cell Filing Advances

Agios Pharmaceuticals (NASDAQ:AGIO) executives said the company is focused on advancing mitapivat across rare hematologic diseases, highlighting early launch traction in thalassemia and a recently submitted supplemental new drug application for sickle cell disease during a presentation at the 2026 R

MarketBeat · May 19

The Apple Watch Ultra 4 is tipped to get a new way to keep your heart healthy — but there’s a catch

The Apple Watch Ultra 4 might get a new blood pressure alert feature, a report claims.

TechRadar · May 19

Gossamer Bio Q1 Earnings Call Highlights

Gossamer Bio (NASDAQ:GOSS) said it is moving ahead with plans to seek U.S. approval for seralutinib in pulmonary arterial hypertension, outlining a September 2026 target for a New Drug Application submission while also detailing new imaging data and steps to address its balance sheet during its firs

MarketBeat · May 18

Flavored vapes led to a major shake-up at the FDA – 3 health policy analysts explain the science behind the controversial products

The resignation of Marty Makary, commissioner of the U.S. Food and Drug Administration, on May 12, 2026, brought to the forefront a heated controversy over fruit-flavored nicotine vapes.

The Conversation · May 18

iRhythm Technologies Touts Medicare Win, Zio Growth and AI-Driven Margin Gains

iRhythm Technologies (NASDAQ:IRTC) executives said the company is seeing continued business momentum after a favorable Medicare coverage update, a stronger-than-expected first quarter and progress on several product and margin initiatives. Speaking at an investor event, Stephanie Zhadkevich, senior

MarketBeat · May 18

Incyte CEO Says Post-Jakafi Growth Path Is Clearer as Pipeline Catalysts Build

Incyte (NASDAQ:INCY) President and CEO Bill Meury said the company’s post-Jakafi growth profile has become “much clearer” over the past year, pointing to continued growth in its commercial business, late-stage pipeline activity and potential launches across oncology and immunology. Speaking at the

MarketBeat · May 18

Doctors explain why maggot therapy is still a leading treatment in the US

The FDA approved medical use of ‘nature’s microsurgeons’ more than 20 years ago

The Independent UK · May 17

GRAIL Says Galleri Demand Is Rising as NHS Talks, FDA Review Move Ahead

GRAIL (NASDAQ:GRAL) said demand for its Galleri multi-cancer early detection test has continued to grow despite recent headlines related to its NHS study, according to comments made by Aaron, who identified himself during the discussion as the company’s CFO, at a Bank of America event. Aaron said t

MarketBeat · May 17

Erasca Touts 'Eye-Popping' ERAS-0015 Lung Cancer Data, FDA Path at BofA Conference

Erasca (NASDAQ:ERAS) executives said the company sees multiple potential development paths for its RAS-targeting portfolio, highlighting early clinical activity for ERAS-0015 in lung, pancreatic and colorectal cancers during a Bank of America biotech conference session. Jonathan Lim, Erasca’s chair

MarketBeat · May 16