FDA

Elon Musk announced plans to make Neuralink‘s brain-computer interface technology “widely available” following the company’s receipt of Breakthrough Device Designation from the Food and Drug Administration for restoring communication in severely speech-impaired individuals....

The President Donald Trump administration’s request for Novavax Inc. (NASDAQ:NVAX) to conduct new clinical trials for its COVID-19 vaccine. What Happened: Novavax announced Monday that the Food and Drug Administration requested a new clinical trial before granting full approval for its...

Several stocks in the health care technology space are moving higher after the market close on Thursday after the U.S. Food and Drug Administration (FDA) announced plans to phase out animal testing requirements. What Happened: The FDA on Thursday announced plans to replace animal testing in...

The Centers for Medicare & Medicaid Services has reportedly eliminated jobs in multiple key divisions, including its Office of Minority Health, as part of a sweeping restructuring effort led by Health and Human Services Secretary Robert F. Kennedy Jr. During a virtual all-hands meeting on...

Peter Marks, the U.S. Food and Drug Administration’s top vaccine official, has resigned, citing concerns over Health and Human Services Secretary Robert F. Kennedy Jr.‘s promotion of vaccine misinformation. Marks, a key figure in the development and distribution of COVID-19 vaccines...

On Tuesday, the U.S. Food and Drug Administration revealed results of new agency testing of over 90 acne products containing benzoyl peroxide for possible benzene contamination. More than 90% of tested products had undetectable or extremely low levels of benzene. As a result, the FDA...

On Monday, Glaukos Corporation (NYSE:GKOS) received the “Day 74” notification from the U.S. Food and Drug Administration (FDA) acknowledging the previously submitted New Drug Application (NDA) for Epioxa (Epi-on), its next-gen corneal cross-linking iLink therapy for keratoconus, a...

Several U.S. Food and Drug Administration (FDA) employees involved in the review of Tesla (NASDAQ:TSLA) Chief, Elon Musk‘s private brain implant company, Neuralink, were reportedly dismissed over the weekend. What Happened: The cuts reportedly affected about 20 individuals from the FDA’...

The U.S. Food and Drug Administration approved the first new pain reliever to hit the market in over 20 years. This medication, produced by Vertex Pharmaceuticals Inc (NASDAQ:VRTX), is a non-opioid and therefore non-addictive. The new drug, suzetrigine, will be sold under the brand name Journavx....

The Food and Drug Administration on Tuesday approved Ozempic, the weight loss drug made by Novo Nordisk A/S (NYSE:NVO), for the treatment of chronic kidney disease in patients who also have type 2 diabetes.  The Details: According to the Centers for Disease Control and Prevention, more than 35.5...

The U.S. Food and Drug Administration (FDA) issued a warning letter to Sanofi SA’s (NASDAQ:SNY) Genzyme Corporation regarding significant violations at its Framingham, Massachusetts, facility. After an inspection conducted between June 12 and July 9, 2024 the agency flagged major concerns...

The U.S. Food and Drug Administration announced a ban on Red No. 3, an artificial food coloring linked to cancer in animal studies, effective Jan. 15, 2027. The dye, found in products ranging from candy to cold medicine, has been scrutinized for decades. This move follows the FDA's 1990...

On Friday, the U.S. Food and Drug Administration approved Eli Lilly and Co.’s (NYSE:LLY) weight loss drug Zepbound for treating sleep apnea What Happened: The FDA’s decision makes Zepbound the first approved drug treatment for patients with obesity and moderate-to-severe obstructive...

The U.S. Supreme Court heard a challenge against the Food and Drug Administration (FDA) Monday about past bans on flavored liquids for e-cigarettes and vapes. What Happened: Triton Distribution brought a case to the U.S. Supreme Court, challenging the law that allows the FDA to control the...

As the formal review process for rescheduling cannabis unfolds, industry players are closely watching its potential to transform the sector. With the DEA hearing delayed until early 2025 and a possible Trump presidency adding uncertainty, cannabis businesses are preparing for what rescheduling to...