FDA expands drug access with self screening rule
Rule could make more medications available over the counter through a process called Additional Condition of Non-prescription Use (ACNU).
Independence Blue Cross to exclude coverage for some drugs that get accelerated FDA approval
Independence Blue Cross has instituted an 18-month benefit exclusion on certain drugs that receive accelerated approval from ...
Exelixis: Bullish On Cabo, Not So Convinced By It's Long-Term Replacement, Zanza
Despite concerns over cabozantinib's patent expiry, Exelixis projects robust future revenues, with lead pipeline candidate ...
The American Journal of Managed Care15h
Collaboration to Transition Members to Preferred Formulary Dipeptidyl-Peptidase-4 Inhibitor
A collaboration between a drug plan and clinical pharmacists led to nearly 50% of members successfully switching to a preferred dipeptidyl-peptidase-4 inhibitor.
JD Supra1d
Balancing Safety and Accessibility: FDA Broadens Approval Pathway for Nonprescription Drugs by Finalizing the ‘ACNU’ Rule
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug ...
JD Supra1d
Scientific Information on Unapproved Uses of Medical Products: FDA’s Final Guidance on Firm Communication to Health Care Providers
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry ...
Healthy Returns: The FDA approved fewer new drugs in 2024 — but some big ones hit the market
The FDA wrapped up 2024 with 50 new drug approvals, clearing a wave of long-awaited treatments. Meanwhile, Transcarent will ...
Pacific Daily News1d
Some GLP-1s Achieve More Weight Loss Than Others: Study
By comparison, the FDA-approved drug liraglutide only resulted in just under 6% weight loss after 26 weeks, the researchers ...
Healio1d
FDA grants priority review to oral non-small cell lung cancer drug
The FDA granted priority review to a new drug application for sunvozertinib as an oral treatment for certain patients with ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
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FDA issues warning to multiple firms selling unapproved seizure medication
According to the FDA, 1 each of the unapproved products were sold on the firm’s websites, Amazon shops, and social media ...
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When Are Confirmatory Trials ‘Underway’? FDA Releases New Accelerated Approval Guidance
Amid recent backlash stemming from market withdrawals and trial delays, the FDA seeks to further clarify its requirements for ...