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...
On May 11, 2023, the United States FDA Pulmonary–Allergy Drug Advisory Committee (PADAC) favored the approval of Neffy, the first intranasal epinephrine spray for allergic reactions. The panel...
The FDA recently approved Omisirge (omidubicel-onlv), a new cell therapy meant to protect patients with blood cancer after a stem cell transplant. According to the press release, the treatment can...
In a news release published Tuesday, the FDA announced that most individuals who already received a bivalent booster vaccine would not be eligible for another dose. FDA officials said they intend to...
This week federal officials announced the $5 billion successor to Operation Warp Speed, dubbed Project Next Gen. The program will seek to address the growing threat of coronaviruses and the possibility...
On April 6, 2023, the FDA Commissioner Robert M. Califf, MD, and Chief Scientist Namandjé Bumpus, PhD, announced the organization’s decision to withdraw the approval of Makena...
On April 3, 2023, the United States HHS released detailed information for a National Cancer Plan. The plan aims to facilitate the Cancer Moonshot initiative. The Biden administration reignited the...
After a series of infections that left several blind, an FDA inspector discovered that the manufacturing facility used to create Global Pharma’s artificial tears failed to follow evidence-based...
One day into his second term, Governor Gavin Newsom of California has announced a partnership between CalRx, a California Department of Healthcare Services program, and Civica, a healthcare nonprofit,...
On March 3, 2023, the FDA issued a safety communication, announcing that it would require and approve changes to prescribing information labels for all allergenic extracts. The new labels should...
Last week, Walgreens announced that it would no longer distribute abortion pills in 20 states across the US following legal warnings made by the attorneys general of those states.
Specifically,...
An investigation published in JAMA Internal Medicine assessed FDA-approved drugs and regulatory decisions made in other countries. In particular, the study focused on regulation and health technology...
Recreational cannabis availability through state-level legalization may contribute to reduced rates of opioid distribution, opioid use disorder (OUD), and overdose. As the opioid epidemic has evolved...
Last week, the FDA approved Gilead Science’s Sunlenca (lenacapavir), the first and only capsid inhibitor-based HIV treatment. The treatment is intended for adult patients whose HIV cannot be...
Major depressive disorder (MDD) — commonly referred to as depression — affects approximately 20% of adults in the United States. MDD symptoms may include depressed mood, appetite changes,...
According to a recent press release, Janssen recently submitted a Biologics License Application (BLA) to the FDA for talquetamab to treat relapsed or refractory multiple myeloma. The CDC states that...
In a Drug Safety Communication issued on November 22, 2022, the FDA announced that it is investigating Prolia and its associations with severe hypocalcemia — low blood calcium levels — in...
Clarity Pharmaceuticals recently announced its Investigational New Drug (IND) approval from the FDA to test theranostic SAR-Bombesin for prostate cancer. Prostate cancer is the fifth leading cause of...
The American Cancer Society states that ovarian cancer is the fifth leading cause of cancer-related death in women in the United States. The organization also says that, in 2022, nearly 13,000 people...
According to the CDC, of all people with diabetes, up to 10% have type 1 diabetes (T1D), sometimes referred to as juvenile or insulin-dependent diabetes. This type of diabetes typically develops early...
