US FDA approves AstraZeneca's drug for breast cancer
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of ...
US FDA approves Amgen's colorectal cancer therapy
The U.S. Food and Drug Administration approved Amgen's combination therapy on Thursday to treat colorectal cancer in patients ...
For first time, FDA approves marketing of nicotine pouch products
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an ...
FDA 'Closely Monitoring' Zyn Nicotine Pouches After Marketing Approval
The Food and Drug Administration (FDA) announced on Thursday that it authorized the marketing of Zyn nicotine pouches but ...
STAT40m
AstraZeneca, Daiichi Sankyo win first U.S. approval for key cancer drug
A drug from AstraZeneca and Daiichi Sankyo won authorization for a form of breast cancer, the first U.S. approval for the ...
FiercePharma2d
Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
The American Journal of Managed Care2d
FDA Grants 2 Traditional Approvals for Acalabrutinib
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
Sarepta, Biogen drugs with accelerated approval under fire in FDA report
A report questions the FDA's accelerated approval process citing Sarepta and Biogen therapies as examples. Read more here.
BioSpace4d
Inspector General Questions FDA’s Accelerated Approval for Biogen, Sarepta Drugs
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, ...
C&EN10d
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 ...
FDA Approves Weight-loss Drug Zepbound For Sleep Apnea – Will Insurance Cover This $1000-Per-Month Medication?
Zepbound is a dual-activating medication that combines glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like ...
rheumatologyadvisor2d
FDA Drug Approval Decisions Expected in February 2025
The FDA is reviewing new vaccines for meningitis and chikungunya and therapies for Parkinson disease and PTSD.