Policy & Regulation News

EPA finalizes chemical plant clean air standards

April 15, 2024 - On April 9, 2024, the United States Environmental Protection Agency (EPA) finalized a ruling to regulate toxic air pollution from chemical plants. The finalized ruling focuses on two primary cancer-causing chemicals: ethylene oxide and chloroprene. Ethylene oxide (EtO) is a flammable colorless gas characterized by a sweet odor that acts as a...

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FDA issues warning letters for unapproved topical pain relief products

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On March 26, 2024, the United States FDA published a press release informing consumers of six warning letters sent to companies regarding unauthorized topical pain relief products. The following...

FDA ODAC favors 2 CAR T-cell therapies for multiple myeloma

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A meeting of the United States FDA Oncologic Drugs Advisory Committee (ODAC) voted to expand the approval of Abecma and Carvykti, two types of chimeric antigen receptor (CAR) T-cell therapies, for...

FDA requests $7.2 billion from Biden’s 2025 fiscal year budget

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On March 11, 2024, the United States FDA issued a press release announcing its request for $7.2 billion from the president’s fiscal year (FY) 2025 budget, increasing its FY 2023 request by 7.4%...

CDC Recommends Additional COVID-19 Vaccine for Elderly Populations

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On Wednesday, February 28, 2024, the CDC’s Advisory Committee on Immunization Practices (ACIP) voted to recommend that individuals ages 65 and older get an additional dose of the 2023–2024...

FDA Approves New First-Line Treatment for Pancreatic Adenocarcinoma

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Adding to existing pancreatic cancer treatment options, the United States FDA granted Ipsen Biopharmaceuticals approval for Onivyde — generically known as irinotecan liposome — for treating...

34% of Conventional Baby Food Contains Pesticides

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Earlier this month, the Environmental Working Group (EWG) published an updated version of their 1995 study on pesticides in baby food. Data revealed that while some threats have been eliminated, there...

FDA Approves First Therapy for Progressing Desmoid Tumors

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On Monday, November 27, 2023, the United States Food and Drug Administration (FDA) approved Ogsiveo (nirogacestat), making it the first FDA-approved treatment for desmoid tumors. The drug is intended...

FDA Approves Truqap, Faslodex for HR-Positive Breast Cancer

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On November 16, 2023, the United States Food and Drug Administration approved AstraZeneca’s Truqap (capivasertib) to be administered in combination with fulvestrant for adults with hormone...

FDA Approves Non-Opioid Painkiller for Mild-to-Moderate Pain

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Earlier this week, Hyloris Pharmaceuticals, a pharmaceutical company headquartered in Belgium, announced the approval of a potent non-opioid painkiller in the United States. The US Food and Drug...

Online Vendors Sell Unapproved GLP-1 Drugs, FDA Issues Warnings

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Last week, the United States Food and Drug Administration (FDA) issued two warning letters to online vendors selling unauthorized versions of semaglutide and tirzepatide, active ingredients in...

First FDA-Approved Biosimilar for Multiple Sclerosis Mimics Tysabri

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On August 24, 2023, the United States Food and Drug Administration approved Tyruko, natalizumab-sztn, a biosimilar for Tysabri (natalizumab), an injectable biologic for managing multiple sclerosis. The...

FDA Issues 15 Warning Letters to Online Retailers Selling E-Cigarettes

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On August 23, 2023, the United States Food and Drug Administration distributed 15 warning letters to online retailers selling or distributing illegal and unauthorized e-cigarettes that appeal to...

FDA Clears IND for New Parkinson’s Disease Treatment Using IPSCs

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Today, Aspen Neuroscience announced that the United States Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for a new Parkinson’s Disease gene...

FDA Approves Second OTC Naloxone for Opioid Overdose Management

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Four months after approving the first over-the-counter (OTC) naloxone, the FDA has made another harm reduction tool available by supporting a second OTC Naloxone nasal spray, RiVive. The nasal spray...

White House National Response Plan Addresses Xylazine, Fentanyl Risk

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A statement issued by the White House on July 11, 2023, outlined a national response plan to address the ongoing risk of fentanyl laced with xylazine. As more illicit drug overdoses are linked to...

Older and Immunocompromised Adults Advised to Get RSV Vaccine

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The Centers for Disease Control and Prevention (CDC) advised older and immunocompromised adults in the United States to get the newly available respiratory syncytial virus (RSV) vaccine. The CDC...

FDA Adds Another Frozen Fruit to Recall List: Listeria Contamination

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On June 22, 2023, the Scenic Fruit Company issued a voluntary recall on frozen pineapple and fruit blends, including frozen pineapple, due to potential contamination with Listeria monocytogenes. This...

FDA Grants Bluebird Bio Priority Review of BLA for SCD Treatment

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On June 21, 2023, Bluebird Bio issued a press release announcing that the FDA had granted its biological license application (BLA) for a new sickle cell disease (SCD) treatment priority review...

FDA Proposes Amendment to Human Prescriptions Drug Labeling Guidelines

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On May 30, 2023, the United States Food and Drug Administration (FDA) proposed an additional Patient Medication Information (PMI) section on human prescription drug labels, amending current...

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