FDA Drug Approvals - Search News

AstraZeneca, FDA and breast cancer

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,

rheumatologyadvisor · 2d

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.

Business Insider · 1d

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.

MarketWatch · 1d

AstraZeneca Gets FDA Approval for Metastatic Breast Cancer Treatment Datroway

AstraZeneca said the U.S. Food and Drug Administration approved Datroway, a treatment for metastatic breast cancer developed in combination with Daiichi Sankyo. The Anglo-Swedish drugmaker on Friday said that the approval is for adult breast cancer patients who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

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 ...

2don MSN

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 ...

MedPage Today3d

HHS Inspector General Raises Concerns Over FDA's Accelerated Approvals

Share on Facebook. Opens in a new tab or window Share on Bluesky. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new tab or window The FDA ...

FiercePharma9d

Breaking down the 55 new drug approvals of 2024

A review of the FDA’s drug approvals of 2024 shows that small companies loomed large—both in the sheer number of nods g | ...

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 ...

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 ...

HealthDay on MSN2d

FDA Approves Omvoh for Moderately to Severely Active Crohn Disease

The U.S. Food and Drug Administration has approved Omvoh (mirikizumab-mrkz) for the treatment of moderately to sever ...

ConsumerAffairs2d

FDA approves 20 ZYN nicotine pouches after thorough' safety review

The U.S. Food and Drug Administration (FDA) has approved 20 ZYN nicotine "pouch" products for sale after what it called "a ...

scrippsnews1d

FDA approves sales and marketing for Zyn nicotine pouches

Marketing for the popular nicotine pouch product, Zyn, has been approved by the U.S. Food and Drug Administration to help ...

healthday1d

FDA Approves Marketing of Nicotine Pouches

Following an extensive scientific review, the U.S. Food and Drug Administration has authorized the marketing of 20 ZYN ...

Becker's Hospital Review3d

Watchdog flags flaws in FDA's fast-track drug approvals

The OIG report points to gaps in documentation and decision-making transparency, particularly in the case of Aduhelm, where FDA records indicated only 13 meetings with Biogen, but congressional ...

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