food and drug administration fda news

FDA expands approval of breast cancer drug Kisqali

FDA awards Novartis expanded approval for breast cancer therapy

The potential market for the Novartis drug Kisqali could grow markedly, now that certain early-stage breast cancer patients will be able to receive it.

Medical Xpress · 1h

FDA expands use of breast cancer drug Kisqali

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.

NBC News on MSN · 14h

FDA expands approval of breast cancer drug Kisqali to earlier-stage patients

The Food and Drug Administration expanded the approval of Kisqali, a drug for metastatic breast cancer, to also treat patients with earlier stages of the disease, drugmaker Novartis said Tuesday.

Zacks.com on MSN · 1h

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,

Merck wins 1st FDA approval for Keytruda

MarketWatch on MSN · 3h

Merck wins first FDA approval for Keytruda as a treatment for mesothelioma

Merck & Co. Inc. said Wednesday the U.S. Food and Drug Administration has approved its blockbuster cancer drug Keytruda as a treatment for malignant plural mesothelioma, a rare cancer associated with asbestos.

Business Insider · 2h

Merck: KEYTRUDA Plus Chemotherapy Gets FDA Approval For Malignant Pleural Mesothelioma In Adults

Drug major Merck & Co., Inc. (MRK) announced Wednesday that the U.S. Food and Drug Administration has approved its anti-PD-1 therapy

Seeking Alpha on MSN · 3h

Merck’s Keytruda label expanded in the U.S. for mesothelioma

Merck (NYSE:MRK) announced Wednesday that the U.S. Food and Drug Administration (FDA) approved a label expansion for its blockbuster therapy Keytruda to allow its use as a first-line combination therapy for mesothelioma,

FDA Alerts Of High Thigh Fracture Risk With Zimmer Biomet's Hip Replacement Device

The U.S. Food and Drug Administration has issued a safety alert about the increased risk of thigh bone fracture after surgery with ...

Zacks.com on MSN2h

BSX Gets FDA Nod on INGEVITY+ Pacing Lead in the LBBA: Stock to Gain?

Boston Scientific Corporation BSX recently received the Food and Drug Administration’s (FDA) approval to expand the ...

FDA Decision Due on Vanda Pharma's Gastroparesis Drug

Vanda has previously said that an FDA green light would make tradipitant the first novel drug approved by the agency in more than four decades for gastroparesis, but in its second-quarter financial ...

Agri-Pulse8h

Food safety advocates push FDA for limit on lead in spices

More than a dozen ground cinnamon products have been recalled over the last year, after the Food and Drug Administration boosted efforts ... to ensure their product has safe levels. This year ...

NBC New York12d

Nearly 2,000 drug plants are overdue for FDA checks after COVID delays, AP finds

An AP analysis of Food and Drug Administration data shows that agency staffers have ... are currently registered to ...

23h

FDA to propose new food label warnings to combat obesity

The FDA is considering food labels to help consumers identify products with unhealthy ingredients, but some experts wonder if ...

19h

The FDA wants to place warning labels on food packages to combat obesity and other health conditions

Front-of-package labels hope to fight rising obesity rates and reduce the prevalence of other health conditions, like ...

Food Safety News2d

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 ...

1hon MSN

Musk's Neuralink gets FDA's breakthrough device tag for 'Blindsight' implant

Elon Musk's brain-chip startup Neuralink said on Tuesday its experimental implant aimed at restoring vision received the U.S.

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