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 ...
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 approves injectable version of Bristol Myers Squibb's cancer drug Opdivo (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
FDA weighs novel pain drug amid opioid crisis
The FDA will decide later this month whether to approve a novel drug for acute pain that could offer a nonaddictive ...
FDA approves first ever medication for obstructive sleep apnea — here's what that means
Tirzepatide is the active ingredient in Zepbound, the FDA approved prescription medicine for Obstructive Sleep Apnea.
Ozempic 3.0? This drug causes the greatest weight loss — by far
Researchers from Canada reviewed the results of 26 trials to determine which of the weight loss jabs are the most effective ...
C&EN1d
50 new drugs received FDA approval in 2024
The US Food and Drug Administration approved 50 new molecular entities in 2024 —just five fewer than it did in 2023. Last ...
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.
Senores Pharmaceuticals receives USFDA approval for Metoprolol Tartrate and Hydrochlorothiazide Tablet
Senores Pharmaceuticals has received final approval from the United States Food and Drug Administration (USFDA) for marketing Metoprolol Tartrate and Hydrochlorothiazide Tablet USP, 50 mg/25 mg and ...
FiercePharma3d
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
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 ...