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 ...
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 ...
Medicare caps seniors drug expenses: What you need to know
Medicare recipients who take expensive prescriptions will get a break this year with a $2,000 cap on drug costs.
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 ...
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 ...
BioSpace2d
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 ...
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).
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 ...
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 ...
Renal & Urology News3d
FDA Denies Approval of Zynquista for Type 1 Diabetes and CKD
The FDA has issued a CRL to Lexicon regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for T1D and CKD.
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 ...
scmp.com6d
FDA approves Chinese eye cancer treatment for development support in the US
The FDA grants orphan status to medicines and biologics for rare diseases that meet certain criteria, opening the way for incentives such as accelerated approval ... are often not obvious, many ...