Legislators try again to create state board to review drug prices
For five years now, a bipartisan group of Illinois lawmakers have wanted to establish a Prescription Drug Affordability Board ...
CNET3d
FDA Finally Bans Red Dye No. 3: What You Need to Know
The US Food and Drug Administration announced this month that it's effectively banning Red No. 3, the controversial ...
Rolling Out1d
Why the FDA says menthol cigarettes must go now
The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...
Monthly Prescribing Reference3d
Nasal Spray Formulation of Bumetanide Under FDA Review
The NDA is supported by data from a clinical trial that compared the absorption and efficacy of the nasal treatment with oral and IV bumetanide in 68 healthy adults.
Merck: FDA grants priority review to sNDA for Welireg
Merck (MRK) announced the U.S. FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg, Merck’s ...
Merck Gets FDA Priority Review of Welireg in Rare Adrenal Tumors
Merck & Co. has won U.S. Food and Drug Administration priority review for its application seeking expanded use of its Welireg oral cancer drug in patients with rare tumors that form in and around the ...
The National Law Review2d
FDA Broadens Oversight of Lab-Developed Tests
Lab-developed tests (LDTs) are laboratory tests where blood is drawn and placed in a test tube to help with identification, ...
MindMed's LSD Anxiety Drug: Revisiting, Rethinking, But Maintaining My 'Hold' Call
Inc. stock despite strong Phase 2b data. Click for my updated look at MNMD stock and its market opportunities.
Becker's Hospital Review2h
FDA warns GLP-1 compounder over safety rules
The FDA issued a warning letter to ProRx, a compounding facility in Exton, Penn., after an inspection raised serious concerns regarding the safety and compliance of its drug products. The facility, ...
JD Supra5m
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
The U.S. Food and Drug Administration (FDA) recently issued two new guidance documents governing details of the Accelerated Approval ...
The National Law Review22h
FDA Develops Strategy to Prevent Adulteration of Berries with Enteric Viral Infections
FDA released a summary of a strategy intended to prevent human norovirus and hepatitis A virus (HAV) outbreaks associated ...