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 ...
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).
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 ...
The American Journal of Managed Care7d
FDA Approves First Subcutaneous Nivolumab Injection in Most Solid Tumors
FDA approves the first subcutaneous version of nivolumab, making PD-1 inhibitors available to new groups of patients.
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.
The Hill10d
FDA approves Zepbound for sleep apnea in obese adults
Sleep apnea causes people to stop and start breathing repeatedly Zepbound is first drug approved by FDA to help ... C-cell tumors in rats, it should not be used for patients with a personal ...
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 ...