Enlarge / Takeda Pharmaceutical Co. Adderall XR brand medication arranged at a pharmacy in Provo, Utah, in November 2023. (credit: Getty | George Frey )

Drug shortages in the US have reached an all-time high, with 323 active and ongoing shortages already tallied this year, according to data collected by the American Society of Health-System Pharmacists (ASHP).

The current drug shortage total surpasses the previous record of 320, set in 2014, and is the highest recorded since ASHP began tracking shortages in 2001.

"All drug classes are vulnerable to shortages," ASHP CEO Paul Abramowitz said in a statement Thursday. "Some of the most worrying shortages involve generic sterile injectable medications, including cancer chemotherapy drugs and emergency medications stored in hospital crash carts and procedural areas. Ongoing national shortages of therapies for attention-deficit/hyperactivity disorder [ADHD] also remain a serious challenge for clinicians and patients."

Enlarge (credit: Amlyx )

Amylyx, the maker of a new drug to treat ALS, is pulling that drug from the market and laying off 70 percent of its workers after a large clinical trial found that the drug did not help patients, according to an announcement from the company Thursday .

The drug, Relyvrio, won approval from the Food and Drug Administration in September 2022 to slow the progression of ALS (amyotrophic lateral sclerosis, or Lou Gehrig's disease). However, the data behind the controversial decision was shaky at best; it was based on a study of just 137 patients that had several weaknesses and questionable statistical significance , and FDA advisors initially voted against approval. Still, given the severity of the neurogenerative disease and lack of effective treatments, the FDA ultimately granted approval under the condition that the company was working on a Phase III clinical trial to solidify its claimed benefits.

Relyvrio—a combination of two existing, generic drugs—went on the market with a list price of $158,000 .

Enlarge / Demonstrators participate in an abortion-rights rally outside the Supreme Court as the justices of the court hear oral arguments in the case of the US Food and Drug Administration v. Alliance for Hippocratic Medicine on March 26, 2024 in Washington, DC. (credit: Getty | Anna Moneymaker )

The US Supreme Court on Tuesday heard arguments in a case seeking to limit access to the abortion and miscarriage drug mifepristone, with a majority of justices expressing skepticism that the anti-abortion groups that brought the case have the legal standing to do so.

The case threatens to dramatically alter access to a drug that has been safely used for decades and, according to the Guttmacher Institute, was used in 63 percent of abortions documented in the health care system in 2023 . But, it also has sweeping implications for the Food and Drug Administration's authority over drugs, marking the first time that courts have second-guessed the agency's expert scientific analysis and moved to restrict access to an FDA-approved drug.

As such, the case has rattled health experts, reproductive health care advocates, the FDA, and the pharmaceutical industry alike. But, based on the line of questioning in today's oral arguments, they have reason to breathe a sigh of relief.

Enlarge / A mother with her twin 6-year-old boys who have metachromatic leukodystrophy, a genetic disease that leaves them unable to move. Photo taken on September 3, 2004. (credit: Getty | John Ewing/Portland Press Herald )

In a medical triumph, US Food and Drug Administration on Monday approved a gene therapy that appears to trounce a rare, tragic disease that progressively steals children's ability to talk, move, and think, leading to a vegetative state and death. For those who begin to slip away in infancy, many die by age 5. But, with the new therapy, 37 children in an initial trial were all still alive at age 6. Most could still talk, walk on their own, and perform normally on IQ tests, which was unseen in untreated children. Some of the earliest children treated have now been followed for up to 12 years—and they continue to do well.

But, the triumph turned bittersweet today, Wednesday, as the company behind the therapy, Lenmeldy, set the price for the US market at $4.25 million , making it the most expensive drug in the world. The price is $310,000 higher than what experts calculated to be the maximum fair price for the lifesaving drug; the nonprofit Institute for Clinical and Economic Review, or ICER, gave a range last October of between $2.29 million to $3.94 million .

The price raises questions about whether state, federal, and private health insurance plans will be able to shoulder the costs. "Unless states have allocated appropriately for it, and looked at the drug pipeline, they may not be prepared for what could be significant cost spikes," Edwin Park, a research professor at the McCourt School of Public Health at Georgetown University, told CNN .

Enlarge / Mature morel mushrooms in a greenhouse at an agriculture garden in Zhenbeibu Town of Xixia District of Yinchuan, northwest China's Ningxia Hui Autonomous Region. (credit: Getty | Xinhua/Wang Peng )

True morel mushrooms are widely considered a prized delicacy, often pricey and surely safe to eat. But these spongey, earthy forest gems have a mysterious dark side—one that, on occasion, can turn deadly, highlighting just how little we know about morels and fungi generally.

On Thursday, Montana health officials published an outbreak analysis of poisonings linked to the honeycombed fungi in March and April of last year. The outbreak sickened 51 people who ate at the same restaurant, sending four to the emergency department. Three were hospitalized and two died. Though the health officials didn't name the restaurant in their report, state and local health departments at the time identified it as Dave’s Sushi in Bozeman . The report is published in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.

The outbreak coincided with the sushi restaurant introducing a new item: a "special sushi roll" that contained salmon and morel mushrooms. The morels were a new menu ingredient for Dave's. They were served two ways: On April 8, the morels were served partially cooked, with a hot, boiled sauce poured over the raw mushrooms and left to marinate for 75 minutes; and on April 17, they were served uncooked and cold-marinated.

Enlarge / Apple AirPods on display at the company's Fifth Avenue store in New York in Feb. 2024. (credit: Bing Guan/Bloomberg via Getty Images)

Apple's AirPods Pro are getting closer to becoming fully fledged hearing aids and marketed as such, according to Bloomberg's Mark Gurman . The move could have a large impact on the hearing aid market, which has already been recently shaken up by over-the-counter models.

Gurman writes that AirPods Pro are due to receive a hearing-aid function in iOS 18, arriving this fall and likely to be announced and outlined at a Worldwide Developers Conference in June. The Wall Street Journal reported in the fall of 2021 that Apple was working toward a future AirPods Pro model that functioned as a hearing aid and would also be able to monitor body posture and even body temperature.

It was not clear from Gurman or the Journal's reporting whether the hearing aid function would be available only in a new model of AirPods Pro or offered as a software update on prior models. Since the Journal's report, Apple has released both a second-generation model of AirPods Pro and a refresh of that model with a USB-C port.

Enlarge / Cinnamon (Photo by Hoberman Collection/Universal Images Group via Getty Images) (credit: Getty | Hoberman Collection )

Six different ground cinnamon products sold at retailers including Save A Lot, Dollar Tree, and Family Dollar contain elevated levels of lead and should be recalled and thrown away immediately, the US Food and Drug Administration announced Wednesday.

The brands are La Fiesta, Marcum, MK, Swad, Supreme Tradition, and El Chilar, and the products are sold in plastic spice bottles or in bags at various retailers. The FDA has contacted the manufacturers to urge them to issue voluntary recalls, though it has not been able to reach one of the firms, MTCI, which distributes the MK-branded cinnamon.

Products identified by the FDA as containing elevated lead levels. (credit: FDA )

The announcement comes amid a nationwide outbreak of lead poisoning in young children linked to cinnamon applesauce pouches contaminated with lead and chromium. In that case, it's believed that a spice grinder in Ecuador intentionally added extreme levels of lead chromate to cinnamon imported from Sri Lanka, likely to improve its weight and/or appearance. Food manufacturer Austrofoods then added the heavily contaminated cinnamon, without any testing, to cinnamon applesauce pouches marketed to toddlers and young children across the US. In the latest update , the Centers for Disease Control and Prevention has identified 468 cases of lead poisoning that have been linked to the cinnamon applesauce pouches. The cases span 44 states and are mostly in very young children.

Enlarge / Peanuts (credit: Getty | CFOTO/Future Publishing )

Living with food allergies can be a fraught existence. There is no cure, and the standard management is to be ever vigilant of everything you eat and have an emergency shot of epinephrine constantly handy in case an accidental ingestion leads to a swift, life-threatening reaction. But, for the millions of people in the US who live with such allergies, a new drug may dull the threat.

On Friday, the Food and Drug Administration approved the antibody drug omalizumab (brand name Xolair) as an injection to lessen allergic reactions to foods in people ages 1 and up. In a trial of 168 children and adults with multiple food allergies, participants who received shots of omalizumab for 16 to 20 weeks were much more likely to tolerate a test dose of allergy-inducing foods at the end than those who received a placebo.

Omalizumab—which was previously approved to treat asthma, hives, and nasal polyps—works by binding to a class of antibodies in the body called immunoglobulin E (IgE) that are specifically involved in allergic responses. The monoclonal antibody drug binds IgE, blocking it from binding to its target receptor, thus preventing it from triggering the immune responses that lead to allergy symptoms.

Enlarge (credit: Nozin.com )

More than four years after SARS-CoV-2 made its global debut, the US Food and Drug Administration is still working to clear out the bogus and unproven products that flooded the market, claiming to prevent, treat, and cure COVID-19.

The latest example is an alcohol-based sanitizer meant to be smeared inside the nostrils. According to its maker, the rub can protect you from becoming infected with SARS-CoV-2 and other nasty germs, like MRSA, and that protection lasts up to 12 hours after each swabbing. That all sounds great, but according to the FDA, none of it is proven. In a warning letter released Tuesday, the agency determined the sanitizer, called Nozin, is an unapproved new drug and misbranded.

While ethyl alcohol is used in common topical antiseptics, like hand sanitizers, the FDA does not generally consider it safe for inside the nostrils—and the agency is unaware of any high-quality clinical data showing the Nozin is safe, let alone effective. The FDA also noted that, for general over-the-counter topical antiseptics, calling out specific pathogens it can fight off—like SARS-CoV-2 and MRSA—is not allowed under agency rules without further FDA review. Making claims about protection duration is also not allowed.