The Latest Breaking News from FDA

The conditions that led to a shortage of baby formula were set in motion long before the February 2022 closure of the Similac factory tipped the U.S. into a crisis.

Mersana Therapeutics, Inc. (NASDAQ: MRSN) received orphan drug designation from the U.S. Food and Drug Administration (FDA) for its drug candidate XMT-2056 or the treatment of gastric cancer. The company is planning to start a clinical study evaluating XMT-2056 for gastric and other cancers.

The COVID-19 quarantine changed everyday life for Americans, including many aspects of our diet, health and exercise regimens. One change that has not received enough scrutiny is that during the pandemic, millions of Americans turned to dietary supplements. In 2020, sales of dietary supplements were 14.5% higher than the previous…

SAN JOSE, Calif. -- With COVID-19 cases rising again in the Bay Area, parents have a new consideration for protecting their children this week: The Food and Drug Administration granted emergency use authorization Tuesday for kids ages 5-11 to get a booster shot of Pfizer’s COVID-19 vaccine.

The Food and Drug Administration has reached an agreement with Abbott Laboratories to resume production at the company’s Sturgis, Michigan, facility. The announcement gives hope of relief for the three-fourths of American parents who rely on infant formula, and have struggled to find the product in recent weeks.

Bad policy makes people vulnerable, and the current baby formula shortage is just the latest example. The immediate cause of the shortage was contamination in a Michigan factory, which might not resume production until June. But the underlying cause is a slew of bad policies that make the market less…

Biden is also authorizing the Defense Department to use commercial aircraft to fly formula supplies that meet federal standards from overseas to the U.S.

Europe's Nestlé SA (OTC: NSRGF) is ramping up hypoallergenic (HA) baby formula production to alleviate the shortage in U.S. supermarkets.

Aldeyra Therapeutics Inc (NASDAQ:ALDX) reported a post-hoc analysis from the completed Phase 3 TRANQUILITY dry eye chamber trial of reproxalap for dry eye disease. Using computer-automated grading of digital photography from the trial demonstrated statistical significance in favor of reproxalap over the vehicle for the primary endpoint of reducing ocular redness.  As previously…