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About 1263 results for "fda"

Quest Diagnostics gets emergency use OK from FDA for Zika test

Quest Diagnostics (NYSE: DGX ) has received emergency use authorization from the FDA for its Zika virus test. It's the first from a commercial lab provider to get an EUA for testing patients for Zika virus RNA, the company says; the CDC had the ... Seeking Alpha, 25 minutes ago

Biocon, Piramal & GSK buck the pharma trend, outperform amid absence of FDA issues

By Kiran Somvanshi ET INTELLIGENCE GROUP: Investors are essentially opportunists. At a time when USFDA has become a dreaded word for pharma stocks and most have lost fancy of the Street, few stocks have found favour with the investors. Biocon, ...
 Economic Times1 hour ago
Med India

FDA Approves Second Biosimilar, Despite Concerns

The U.S. Food and Drug Administration (FDA) approved the second biosimilar since issuing its draft labeling guidelines for these novel, complex drugs in late March—despite ongoing concerns about patent protection and patient safety. 1 This ...
 Cancer Therapy Advisor24 minutes ago FDA approves biosimilar to J&J's Remicade for multiple diseases  Reuters3 weeks ago FDA advisory panel strongly backs biosimilar Remicade  Reuters2 months ago Biosimilar Version of Remicade for Autoimmune Diseases Likely to Get FDA Approval  Med India2 months ago
Monthly Prescribing Reference

Sarepta Spikes 20%, Feuerstein Says Company Can Win FDA Drug Approval

Shares of Sarepta were hard hit after a federal advisory panel voted that the company's eteplirsen drug for the treatment of Duchenne muscular dystrophy (DMD) was not effective. Feuerstein stated that while the advisory panel members ultimately ...
 Morningstar.com8 hours ago Jim Cramer -- Will FDA Approve Sarepta's Duchenne Drug After All?  TheStreet.com10 hours ago Sarepta Can Win Speedy FDA Drug Approval  TheStreet.com10 hours ago FDA Advisory Committee Votes Against DMD Drug Approval  Monthly Prescribing Reference4 hours ago
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India Infoline

Lupin strengthens branded drug business in US

The drug, Methergine, is the only FDA approved oral uterotonic and Lupin has created of a specialised sales force to drive product sales
 Business Standard10 hours ago Intuity Medical gets US FDA nod to market POGO Automatic Blood Glucose Monitoring System  PharmaBiz1 day ago BRIEF-Collegium Pharmaceutical gets FDA approval for XtampzaER  Reuters UK2 days ago Glenmark Pharma pares gains despite FDA nod; ends in the green though  India Infoline2 days ago
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QMED

US FDA seeks additional information from Otsuka & Proteus for their digital medicine

Otsuka Pharmaceutical Co., Ltd. (Otsuka) and leading digital medicine company, Proteus Digital Health (Proteus) announced that the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for their digital ...
 PharmaBiz18 hours ago BRIEF-Otsuka Pharmaceutical says FDA issued CRL for co, Proteus Digital Healths digital medicine  Reuters UK1 day ago Proteus, Otsuka Seek to Resolve FDA Concerns on Digital Medicine  Dow Jones Financial Information Services1 day ago FDA Wants More Info on Smart Pill-Abilify Combo  QMED1 day ago
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Accuray seeks US FDA marketing approval for Radixact treatment delivery system

Accuray Incorporated, a radiation oncology company, announced the submission of its 510(k) premarket notification with the Food and Drug Administration (FDA) for the company's Radixact Treatment Delivery System. Accuray also submitted 510(k) ...
 PharmaBiz13 hours ago Accuray seeks FDA approval for Radixact treatment delivery system  Medical Devices Business Review1 day ago ACCURAY : Submits 510(k) Premarket Notification to FDA for Its Radixact(TM) Treatment Delivery System  4 Traders2 days ago Biodenta North America Introduces FDA-Cleared Open System for Custom Abutments  LMTmag.com3 days ago
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Monthly Prescribing Reference

FDA approves Exelixis' cabozantinib

FDA has approved cabozantinib (Cabometyx—Exelixis) tablets for the treatment of patients with advanced renal cell carcinoma who have previously received anti-angiogenic treatment. FDA has approved cabozantinib (Cabometyx—Exelixis) tablets for ...
 Pharmacist.com6 hours ago US FDA approves Exelixis' Cabometyx tablets to treat advanced RCC who have received prior anti-angiogenic therapy  PharmaBiz1 day ago FDA Approves Cabometyx  CPhI.cn1 day ago FDA approves Cabozantinib for the treatment of advanced renal cell carcinoma  European Cancer Organisation2 days ago
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Pharmaceutical Business Review

Novartis' Ilaris wins three FDA breakthrough designations to treat periodic fever syndromes

Novartis has secured three breakthrough therapy designations from the US Food and Drug Administration (FDA) for Ilaris (canakinumab) to treat rare types of periodic fever syndromes. The three conditions for which Ilaris is being reviewed include ...
 Pharmaceutical Business Review16 hours ago Novartis Ilaris receives FDA breakthrough status to treat fever syndromes  Reuters UK1 day ago Novartis receives three FDA Breakthrough Therapy Designations for Ilaris to treat rare types of Periodic Fever Syndromes  Nasdaq1 day ago Bristol-Myers' Opdivo wins FDA breakthrough designation for head and neck cancer  Pharmaceutical Business Review2 days ago
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UPI

Potential Lawsuit: FDA Evaluating Risk of Miscarriage with Oral Fluconazole in Pregnancy

Santa Clara, CA: The US Food and Drug Administration (FDA) is evaluating the results of a Danish study that conclude there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. The FDA is ...
 Lawyers & Settlements3 hours ago New Health Study: Pregnant Women Shouldn't Use Fluconazole To Treat Yeast Infections, FDA Warns it Greatly Increases Miscarriage Risk  Inquisitr1 day ago Yeast infection drug may raise miscarriage risk, FDA warns  UPI2 days ago FDA: Fluconazole Linked to Increased Miscarriage Risk  Physician's Briefing1 day ago
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