FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or metastatic hormone receptor HR+, HER2- breast cancer in adult patients who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease, according to a news release.
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 breast cancer, the health regulator said on Friday. The treatment, jointly developed with the Japanese company,
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 closely watched treatment.
Daiichi Sankyo Shares Jump After U.S. FDA Approves Breast Cancer Drug
Daiichi Sankyo shares rose sharply after the U.S. Food and Drug Administration approved its breast cancer drug Datroway. Shares were recently 8.7% higher at 4,437 yen, equivalent to $28.39, on Monday after rising as much as 9.7% earlier. Over the past three years, the stock posted a daily gain of more than 8% only four times.
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 with a specific gene mutation.
AstraZeneca’s Datroway approved in U.S. for HER2-negative breast cancer patients
DXd, has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
FDA’s START and CoGenT pilot programmes: Streamlining rare disease drug approvals
These initiatives represent a way to accelerate access to treatments that have historically faced longer regulatory pathways.
JD Supra19m
FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding ...
FiercePharma4d
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 ...
Medscape12h
FDA Approves Sotorasib + Panitumumab for mCRC
In the CodeBreaK 300 trial, sotorasib and panitumumab had better response rates and improved PFS vs standard-of-care ...
JD Supra36m
Drugs and Biologics at FDA: Reflections on 2024 Activity Shed Light on the Road Ahead
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...
Biogen, Sarepta Quick Drug Approvals Show FDA Gaps, Report Says
Approvals for drugs from Biogen Inc. and Sarepta Therapeutics Inc. show flaws in the process US drug regulators use to speed ...
The American Journal of Managed Care3d
FDA Grants 2 Traditional Approvals for Acalabrutinib
The Bruton tyrosine kinase inhibitor was approved in combination with bendamustine and rituximab in previously untreated ...
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 ...