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...
According to 2017 CDC data, over 31,000 people are living with amyotrophic lateral sclerosis (ALS) in the United States. In America, approximately 5,000 individuals are diagnosed with ALS annually. ALS is associated with high costs, as the...
Despite valiant efforts by other pharmaceutical companies — namely, Pfizer — GSK has secured its spot in the respiratory syncytial virus (RSV) vaccine market, becoming the first-ever...
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...
On Tuesday, GSK announced that it had reached an agreement to acquire Bellus Health Inc. for nearly $2 billion. Bellus, a Canada-based biopharmaceutical company, will provide GSK access to camlipixant,...
On April 3, 2023, Vertex Pharmaceuticals and CRISPR Therapeutics announced that they submitted Biological License Applications (BLAs) for an investigational treatment using exagamglogene autotemcel...
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 Friday, April 7, 2023, a federal judge in Texas ruled to reverse the approval of mifepristone, the abortion pill. The Trump-appointed judge, Mathew Kacsmaryk, was assigned to the Alliance for...
On Wednesday, the FDA approved Narcan nasal spray for non-prescription over-the-counter use, making it available to consumers across various markets and retail locations. The approval went to Emergent...
On March 24, 2023, the FDA issued a draft guidance on the clinical trial considerations for the accelerated approval of oncology drugs. The proposed recommendations include guidelines to fortify and...
On March 16, 2023, just days after the FDA approved another new nasal migraine medication, Pfizer recalled its Nurtec ODT medication. Under advisement from the United States Consumer Product Safety...
On Monday, the European healthcare company Sanofi announced a $2.9 billion acquisition deal with US-based Provention Bio. Under the terms of the agreement, Sanofi will pay $25 per share in cash,...
With a new FDA-approved immunotherapy treatment designed to delay the onset of type 1 diabetes (T1D), patients — 8 years or older — can enjoy more years without the physical and financial burdens of living with...
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...
The Orphan Drug Act of 1983 defines a rare disease as a medical condition that impacts less than 200,000 people in the United States. Despite the restrictive nature of this definition, the Genetic and Rare Diseases Information Center of...
Based on the results of a double-blind, placebo-controlled, the FDA granted the accelerated approval of Leqembi for Alzheimer’s disease, making it the second approved medication targeting the...
Throughout the COVID-19 pandemic, the FDA has played a critical role in addressing public health concerns by encouraging practices to minimize infectious disease spread and expediting approval for...
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,...
