FDA expands approval of breast cancer drug Kisqali
U.S. FDA declines to approve Vanda's stomach paralysis drug
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms, the company said on Thursday.
Kisqali wins FDA nod for breast cancer treatment: Dosage, effectiveness and side effects of the breakthrough drug
The US FDA has approved Kisqali (ribociclib) for treating early-stage breast cancer in combination with hormone therapy. It targets high-risk HR-posit
FDA Expands Use of Breast Cancer Drug Kisqali
The FDA approval of Kisqali for this early breast cancer population, including those with NO [hasn't spread to nearby lymph nodes] disease, is a pivotal moment in improving our approach to care,” said Dr.
Novartis CEO says FDA's extended approval of breast cancer drug is a 'landmark' for the firm
Vas Narasimhan, CEO of Novartis, comments on the progress of the firm's Kisqali metastatic breast cancer drug after the company recently received an extended approval for it from the U.S. Food and Drug Administration.
FDA Expands Approval Of Breast Cancer Drug Kisqali To Earlier-stage Patients
Women with early-stage breast cancer may now take Kisqali, a medication already approved for advanced disease, following the U.S. Food and Drug Administration's expanded approval of the treatment, drug maker Novartis announced Tuesday.
Breast cancer drug Kisqali gets FDA approval to prevent cancer recurrence
The breast cancer drug Kisqali has received FDA approval to reduce cases of cancer recurrence. The drug was found to reduce the chances of a patient's breast cancer coming back by 25%.
FDA expanded their approval on drug cancer drug
First News
Novartis Wins FDA Approval of Kisqali for Early Breast Cancer
Novartis NVS announced that the FDA has approved breast cancer drug Kisqali (ribociclib) for a broader population. The regulatory body approved Kisqali in combination with an aromatase inhibitor (AI) for the adjuvant treatment of people with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) at high risk of recurrence,
The FDA wants to place warning labels on food packages to combat obesity and other health conditions
The Food and Drug Administration (FDA) is looking to propose the inclusion of front-of-package warning labels that detail the ...
Food Safety News4d
FDA warns food companies for violations in acidified foods and seafood imports
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
philstar.com1mon
Food and Drug Administration
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The Sacramento Observer3d
Here’s Why Food Recalls — and Consumers Getting Sick — Are Increasing
Overview: A government watchdog group says the U.S. food industry is on track to set records for the number of people who have died from consuming tainted meats, produce and eggs — a warning sign of ...
Senators Target Influencers, Telehealth Firms for Misleading Weight-Loss and Other Drug Promotion
The legislation would allow the FDA to warn and fine companies and individuals who post false information online about medications such as Ozempic and Wegovy.
Investopedia10d
Food and Drug Administration (FDA): What It Is and Does
Her expertise is in personal finance and investing, and real estate. The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public ...
Asia One5d
Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration
On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and ...
Bangkok Post28d
Food and Drug Administration hastens approval for mpox kits
The Food and Drug Administration (FDA) has opened registration for mpox diagnostic test kits amid growing concerns over the spread of the viral infection. Lertchai Lertwut, FDA deputy secretary ...
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LENZ Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for LNZ100 for the Treatment of Presbyopia
to U.S. Food and Drug Administration (FDA) for LNZ100 (an aceclidine-based ophthalmic solution) for the treatment of presbyopia, a condition impacting an estimated 1.8 billion people globally ...
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Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration
The Breakthrough Therapy designation stems from the provisions of the "Food and Drug Administration Safety and Innovation Act". It is designed to expedite the development and regulatory review ...
JD Supra4d
Recap of the FDA and CTTI Public Workshop on AI in Drug Development
On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative ...