Category: FDA

March 8, 2024

Instead of approving the new Alzheimer’s drug donanemab this month, as was expected, the U.S. Food and Drug Administration will now require the experimental medication be scrutinized more closely by an expert panel, the drug’s maker said Friday. “The FDA […]

March 4, 2024

As new outbreaks of measles — a once nearly eliminated illness in the United States — continue to emerge, experts remind Americans that there’s an easy way to stop infection: Get vaccinated. “Measles spreads so easily that if one person […]

February 28, 2024

PFAS “forever” chemicals, increasingly linked to health risks, will no longer be added to food packaging handled by American consumers, the U.S. Food and Drug Administration announced Wednesday. “Grease-proofing materials containing per- and polyfluoroalkyl substances [PFAS] are no longer being […]

February 27, 2024

The FDA’s decision sets back many years of effort by Minerva to secure approval of its drug for schizophrenia, called roluperidone and designed to treat so-called negative symptoms of the condition. The company, which licensed rights to roluperidone from Mitsubishi […]

February 26, 2024

Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. Biosimilars, according to the FDA, are biological products that are highly similar to […]

February 22, 2024

In an unusual move, United Therapeutics has filed a lawsuit against the FDA which claims the regulator is sidestepping established norms in allowing rival Liquidia to file for approval of a competitor to its Tyvaso product. The suit claims that […]

February 21, 2024

On Feb. 15, 2024, FDA’s Center for Drug Evaluation and Research (CDER) released its report, Drug Safety Priorities FY23. The report describes the center’s key safety programs and activities involved in promoting and protecting public health and dealing with the […]

February 21, 2024

The stock plunged almost 74% after the announcement of a “serious adverse event” – a case of liver failure – in the trial involving patients with atopic dermatitis, also known as eczema. RAPT said the FDA had “verbally notified” it […]

February 16, 2024

People threatened by accidental exposure to foods they’re allergic to may have a new weapon of defense: On Friday, the U.S. Food and Drug Administration expanded the use of the asthma drug Xolair to help prevent anaphylactic reactions. Xolair (omalizumab) […]

February 14, 2024

Pancreatic cancer remains one of the most difficult tumors to treat, with few good options after cancerous cells have spread more widely. More than 60,000 people are diagnosed with the adenocarcinoma form each year, according to Ipsen, often after metastases. […]

February 9, 2024

America’s most popular cold medications contain a nasal decongestant that doesn’t work, creating a knotty dilemma for regulators, a new study reports. Cold remedies containing phenylephrine remain consumers’ most popular choice, despite decades of concern that the decongestant simply isn’t […]

February 1, 2024

Certain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday. The packaging for South Moon, Rebright and FivFivGo eyedrops mirrors the packaging for Bausch & Lomb’s Lumify eyedrops, […]

January 31, 2024

Revolo Biotherapeutics announced on Jan. 30, 2024 that FDA has granted Orphan Drug Designation to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo focuses on developing therapies that reset the immune system […]

January 25, 2024

Reiterating a warning first issued in November, the U.S. Food and Drug Administration is urging Americans to stay away from supplements containing tianeptine, known on the street as “gas station heroin.” The supplements, sold under the brand name Neptune’s Fix […]

January 12, 2024

The concerns over suicide ideation — thinking about or planning suicide — emerged last year when the Icelandic drug agency reported to the EMA two cases in people taking GLP-1s. One was taking Saxenda, Novo Nordisk’s daily weight-loss shot, and […]

January 11, 2024

Amid an ongoing shortage of the first-line treatment for syphilis in the United States, the U.S. Food and Drug Administration will allow the importation of a different syphilis drug from a French drugmaker. In a letter from Laboratoires Delbert, the […]

January 4, 2024

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]

December 22, 2023

The US approval is the first in the world for Wainua (eplontersen), a once-monthly antisense treatment that can be self-administered by subcutaneous injection. According to AZ and Ionis, it is the only drug for ATTR polyneuropathy that doesn’t need to […]

December 21, 2023

The latest complete response letter (CRL) for gefapixant comes even though the drug is already on the market in Europe and Japan under the Lyfnua brand name, and less than two years after the FDA first rejected it in January […]

December 19, 2023

Cinnamon samples gathered at a facility in Ecuador linked to tainted applesauce pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards, according to U.S. Food and Drug Administration inspectors. Tests conducted at […]