A Cancer Drug, Avastin, May Lose F.D.A. Approval
A Cancer Drug, Avastin, May Lose F.D.A. Approval
In a series of 6-0 votes, an advisory committee to the F.D.A. endorsed the agency’s proposal to revoke the approval of the drug for use against advanced breast cancer.
Read more on New York Times
FDA approval for breast cancer drug could be rescinded
Owen Jensen reports: Officials at the Food and Drug Administration have said that their earlier approval of the breast cancer treatment Avastin could soon be revoked in the wake of a report from an advisory committee, which found that the benefits of the drug for many patients are outweighed by its serious side effects.
Watson Announces Novel Oral Contraceptive Approval
Watson Announces Novel Oral Contraceptive Approval
Watson Pharmaceuticals today announced the U.S. Food and Drug Administration approval of a novel oral contraceptive product â the first and only low dose oral contraceptive to combine 0.8 mg norethindrone and 0.025 mg ethinyl estradiol in chewable form, with four 75 mg ferrous fumarate placebo tablets.
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Categories: Breast Cancer Information Tags: Announces, Approval, Contraceptive, novel, Oral, Watson
SPRYCEL receives FDA approval for adult patients with Ph+ CML in chronic phase
SPRYCEL receives FDA approval for adult patients with Ph+ CML in chronic phase
After receiving a priority review, Bristol-Myers Squibb Company and Otsuka Pharmaceutical Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved SPRYCEL (dasatinib) 100 mg once daily for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
Read more on News-Medical-Net
Novartis Gains FDA Approval For Gilenya™, A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly …
Novartis Gains FDA Approval For Gilenya™, A Novel First-Line Multiple Sclerosis Treatment Shown To Significantly …
Today Novartis announced that the US Food and Drug Administration (FDA) approved the oral multiple sclerosis (MS) treatment Gilenya™ (fingolimod) 0.5 mg daily, a first-line treatment for relapsing forms of multiple sclerosis – the most common forms of the disease.
Read more on PharmaceuticalOnline
Categories: High Risk Breast Cancer Tags: Approval, FirstLine, gains, Gilenya™, Multiple, Novartis, novel, Sclerosis, Shown, significantly, Treatment
FDA denies accelerated approval for ImmunoGen, Genentech potential breast cancer treatment
FDA denies accelerated approval for ImmunoGen, Genentech potential breast cancer treatment
WALTHAM, Mass. – Federal regulators have ruled that a potential breast cancer treatment from ImmunoGen failed to meet the standard for accelerated approval, the company said Friday.
Read more on Minneapolis-St. Paul Star Tribune
Categories: Breast Cancer Treatment Tags: Accelerated, Approval, breast, cancer, Denies, Genentech, ImmunoGen, Potential, Treatment
FDA could revoke drug’s approval for breast cancer
FDA could revoke drug’s approval for breast cancer
Advisory panel says Avastin’s authorization should be revoked
Read more on San Jose Mercury News
Biocancell Receives U.S. FDA Approval To Continue Phase IIb Superficial Bladder Cancer Clinical Trial And Interim …
Biocancell Receives U.S. FDA Approval To Continue Phase IIb Superficial Bladder Cancer Clinical Trial And Interim …
Tikcro Technologies Ltd. (OTC BB: TIKRF) announced that BioCancell Therapeutics, Inc. (“Biocancell”), concluded the first 18 patient group treated pursuant to a Phase IIb clinical trial of the drug candidate BC-819 for use in superficial bladder cancer. These patients had not responded to conventional treatment (BCG or chemotherapy). This was the first of two groups in a trial totaling 33 …
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Categories: Breast Cancer Chemotherapy Tags: Approval, Biocancell, Bladder, cancer, Clinical, Continue, Interim, Phase, receives, Superficial, Trial, U.S.
Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU
Eisai Submits Simultaneous Regulatory Applications for Approval of Eribulin Mesylate in Japan, U.S. and EU
Eisai Inc. today announced that it has submitted simultaneous regulatory applications for approval of eribulin mesylate for the treatment of locally advanced or metastatic breast cancer to agencies in Japan, the United States and the European Union .
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Categories: Breast Cancer Research Tags: Applications, Approval, Eisai, Eribulin, Japan, Mesylate, Regulatory, Simultaneous, Submits, U.S.