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Summit outlines November 14 FDA PDUFA date for ivonescimab BLA while planning HARMONi-3 PFS in 2H 2026 (NASDAQ:SMMT)

Earnings Call Insights: Summit Therapeutics (SMMT) Q2 2026

Management View

  • Robert Duggan (Co-CEO & Executive Chairman) said, “we expand our clinical development plan and prepare for commercialization in anticipation of a decision from the FDA on our BLA towards the end of this year,” and highlighted

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Taylor Farms: FDA mistakenly reports parasite in lettuce amid recall

July 20 (UPI) — Taylor Farms said late Sunday the Trump administration mistakenly informed it that a sample of its shredded iceberg lettuce tested positive for a parasite amid a multi-state outbreak that prompted the U.S.-based fresh-produce giant to initiate a recall of the salad staple distributed to 27 states.

The Food and Drug Administration reversed the finding Sunday, determining that the purported positive test for the microscopic Cyclospora parasite, which causes the intestinal illness cyclosporiasis, was a false positive.

“Today, FDA apologized to us,” the company said in a statement.

“Today, we were informed that FDA made a mistake.”

Taylor Farms had initiated the voluntary recall Friday after federal health investigators linked shredded iceberg lettuce sourced from central Mexico to a multi-state cyclosporiasis outbreak through a traceback investigation.

At least 1,644 people in five states have been infected, including 94 hospitalizations, since May 13, according to the U.S. Centers for Disease Control and Prevention, which said there have been no fatalities.

Federal health investigators have linked the illnesses to shredded iceberg lettuce served at Taco Bell locations in Indiana, Kentucky, Michigan, Ohio and West Virginia.

The FDA said Friday that its traceback investigation identified the supplier as Taylor Farms de Mexico. The company then initiated the voluntary recall.

On Saturday, federal investigators said a sample collected during targeted import surveillance tested positive for Cyclospora. The FDA said the produce was not part of the initial recall and investigators were working to identify whether any of the lot was available in commerce.

A day later, Taylor Farms said it was informed of the FDA’s “mistake.”

“To be clear, at this moment, the FDA has not identified a single positive product test result for Cyclospora,” it said.

The FDA told media it had discovered the false positive after rechecking the results of the purported positive sample.

“As of July 19, 2026, there are no confirmed positive sample results for product testing for Cyclospora,” the FDA said in a statement, NBC News reported.

Taylor Farms said it had completed the voluntary recall, which was limited to iceberg lettuce grown and processed in central Mexico, and that all of its other produce is available for purchase.

“Our thoughts remain with everyone who has fallen ill in this outbreak,” it said.

“We are committed to working with public health authorities as the ongoing outbreak investigation continues.”

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FDA recalls millions of bottles of eye drops over possible ‘foreign substance’

July 9 (UPI) — The Food and Drug Administration on Thursday recalled more than 2.5 million bottles of eye drops because they may contain a “foreign substance.”

The nationwide recall was initiated by Lupin Pharmaceuticals on June 4 because of some type of foreign substance, though the company and the FDA have not identified it or how it got into the eye drops, MassLive and NJ.com reported.

The class II recall of the prednisolone acetate eye drops — used to reduce inflammation after eye surgery or for allergic and other conditions — is the second-highest risk recall for the agency because it may cause adverse consequences if used.

In a recall notice posted on its website on Thursday, the FDA said that the recall of more than 2.5 million bottles of Lupin’s prednisolone eye drops was because of the “presence of foreign substance.”

The affected bottles come in 5 mL, 10 mL and 15 mL quantities, and were produced by the India-based Lupin, which specializes in manufacturing generic pharmaceutical medications.

The FDA also cautions against simply pausing the use of these medications, suggesting that people who need to use them contact their eye doctor or pharmacist in order to properly react for their own conditions.

Olympic canoeist David Hearn departs the Moultrie Courthouse after pleading not guilty to damaging the Lincoln Memorial Reflecting Pool on Thursday. Hearn was indicted on July 2 on one count of destruction of property of more than $1,000 for allegedly damaging the Reflecting Pool, carrying a maximum penalty of 10 years in prison if convicted. Photo by Bonnie Cash/UPI | License Photo

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FDA expands sunscreen options, adds bemotrizinol

A woman applies sunscreen to her face. On Tuesday, the U.S. Food and Drug Administration said it will allow the first new permitted ingredient in over-the-counter sunscreens in 20 years. File Photo by Bill Branson/National Cancer Institute

June 9 (UPI) — The U.S. Food and Drug Administration on Tuesday added bemotrizinol to the list of permitted active ingredients in over-the-counter sunscreens, the first addition to that list since the 1990s.

The Department of Health and Human Services “is advancing innovation by bringing a new sunscreen ingredient to the U.S. market for the first time in 20 years,” HHS Secretary Robert F.Kennedy Jr said. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products.

The FDA said the ingredient has low levels of absorption through the skin and into the body and is generally recognized as safe and effective for adults and children 6 months old and older.

The American Chemical Society said that BEMT blocks ultraviolet A and ultraviolet B light rays and was first used in sunscreens in the European Union in 2000, with Canada, Australia and some countries in Asia following suit soon after.

UV B rays have more energy, cause visible sunburns and are the ones blocked by most U.S. sunscreens today. However, UV A rays can also cause skin cancers, the American Cancer Society said. They also cause skin cells to age and can cause indirect damage to cells’ DNA. The ACS said about 95% of the UV rays that reach the ground are UV A rays.

The FDA said an over-the-counter monograph drug, such as a sunscreen product, can enter the market without an approved drug application if it meets certain requirements. DSM Nutritional Products LLC submitted an OTC monograph order request to add BEMT, at concentrations up to 6%, as a new active ingredient in the OTC monograph for sunscreens. The FDA proposed to add BEMT in December, and the public could submit comments through Jan. 26.

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Supreme Court, over two dissents, upholds abortion pills sent by mail, for now

The Supreme Court on Thursday rejected an antiabortion challenge to federal regulations that permit sending pills through the mail once a patient has consulted a doctor online.

The justices granted an emergency appeal from the makers of mifepristone and set aside an order from a U.S. appeals court in Louisiana that would have made it illegal to send or receive the medication by mail.

Justices Clarence Thomas and Samuel A. Alito Jr. dissented.

“The court’s unreasoned order granting stays in this case is remarkable,” Alito wrote. “What is at stake is the perpetration of a scheme to undermine our decision in Dobbs v. Jackson Women’s Health Organization, which restored the right of each State to decide how to regulate abortions within its borders.”

The decision is a setback for abortion opponents, including Louisiana Atty. Gen. Liz Murrill, who sued and argued that her state’s ban on abortion has been thwarted by abortion pills sent by mail.

Thursday’s order preserves access to the medication under the current rules, but it is not a final decision.

The case will now return to the 5th Circuit Court in New Orleans for further review.

“Today’s ruling buys time, but no peace of mind,” said Nancy Northup, president of the Center for Reproductive Rights. “Mifepristone access remains highly at risk as this case moves forward and the Trump administration conducts a politically motivated review of this pill with the hardly disguised aim of making it harder to get.”

National Right to Life expressed deep disappointment.

“Women facing unexpected pregnancies deserve real medical care and support, not a one-size-fits-all mail-order abortion system that minimizes risks and leaves women isolated during medical emergencies,” said Carol Tobias, the group’s president.

The legal dispute has put the Trump administration in a politically awkward spot.

Critics of abortion, including Republican attorneys general from 23 states, argued that the regulations adopted during the Biden administration have thwarted their state laws and allowed patients to obtain medication from doctors in California and New York.

But the Trump administration has shown no urgency to change the regulations that allow for dispensing the pills by mail.

Alito, who spoke at the 5th Circuit a week ago, said he agreed with the state’s argument.

“Louisiana’s efforts have been thwarted by certain medical providers, private organizations, and States that abhor laws like Louisiana’s and seek to undermine their enforcement,” he wrote. “These medical providers and private organizations have developed an operation enabling women in Louisiana and other States that restrict abortions to place an online order for a pill called mifepristone that induces abortion.”

Thomas said abortion is a crime in Louisiana.

The makers of the abortion pills have no grounds to sue “based on lost profits from their criminal enterprise. They cannot, in any legally relevant sense, be irreparably harmed by a court order that makes it more difficult for them to commit crimes.”

But most of the court’s conservatives refused to go along, even though they had voted to overturn the constitutional right to abortion.

Chief Justice John G. Roberts and Justices Neil M. Gorsuch, Brett M. Kavanaugh and Amy Coney Barrett refused to block the current regulations on a fast-track appeal.

Two years ago, the court handed down a similar decision involving abortion pills and the 5th Circuit Court.

The justices overturned a 5th Circuit ruling on the grounds that the antiabortion doctors who sued had no standing because they did not prescribe or use the medication.

In 2000, the FDA approved the use of mifepristone as safe and effective for ending an early pregnancy or treating a miscarriage. It is used in combination with a second drug misoprostol, which induces cramping.

Since 2016, the FDA has relaxed regulations on its use. They include a requirement that women obtain the pills directly from a doctor or a medical clinic. However, it was understood the medication would be taken later at home.

The agency temporarily suspended this rule in 2021 in response to the COVID-19 pandemic, then lifted it entirely in 2023.

Medication abortions now account for almost two-thirds of abortions in the United States, and telehealth is used in 27% of abortions nationwide. Last year, in response to abortion opponents, the Trump administration agreed to review the safety record of mifepristone.

“Mifepristone is one of the safest and most well-studied drugs on the market,” said Dr. Camille A. Clare, president of the American College of Obstetricians & Gynecologists. “The FDA removed the in-person dispensing requirement after careful evaluation of the data because mifepristone is safe and effective even when distributed by mail.”

But the Louisiana attorney general decided to sue in federal court without waiting for the FDA.

She argued that the mailing of abortion medication, which was approved under the Biden administration, was undermining her state’s strict ban on abortions.

A federal judge in Louisiana said the state appeared to have a strong claim, but he decided not to rule on it until the FDA completed its review.

The 5th Circuit Court of Appeals responded a few days later by ruling the FDA erred by relaxing its regulations to allow for dispensing the pills by mail. The three-judge panel then put its ruling into effect immediately on May 1.

Abortion law experts called out the decision as extreme and unusual.

“To our knowledge, no court has ever ordered the FDA to reimpose on a drug a safety rule the agency has thoroughly studied and deemed unnecessary,” said Melissa Goodman, executive director of UCLA’s Center for Reproductive Health, Law and Policy.

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