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About 1026 results for "us food and drugs administration"

J&J's long-lasting diabetes combo approved in US
pharmaphorum

FDA approves Johnson & Johnson's autoimmune drug Stelara for C...

Johnson & Johnson said on Monday that the U.S. Food and Drug Administration approved the company's blockbuster psoriasis drug, Stelara, for use in adults with Crohn's disease. The drug, which blocks two inflammation-causing proteins IL-12 and IL-23, ... Financial Express, 50 minutes ago
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India Infoline

Sensex, Nifty continue to rally; ITC gains 2%, Wockhardt up 10%

Wockhardt shares surged 10 percent after sources told CNBC-TV18 that health regulator US Food Drug Administration has cleared company's Chikalthana plant that contributes 75 percent to total income.
 Money Control1 week ago Wockhardt slumps as USFDA issues import alert on the company's Ankleshwar unit  Business Standard1 month ago Wockhardt falls 14 pct on import alert; Macquarie downgrades  Business Standard1 month ago Glenmark receives USFDA nod and other top pharma news  India Infoline1 month ago
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Money Control

USFDA warns Pan Drugs for violations of CGMP norms

In a warning letter to Pan Drugs MD and Chairman Kamal Pandya, US Food and Drug Administration (USFDA) said the company's "methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are ...
 Money Control2 weeks ago
FOXNews.com

The world's best-selling drug is in line for cheaper competition — eventually

The Food and Drug Administration on Friday approved a lower-cost version of the world's top-selling drug, but don't expect to see it at the pharmacy any time soon. Biotech giant Amgen won FDA approval for its version of Humira, an ...
 StatNews.com2 days ago U.S. FDA approves Amgen's copy of AbbVie arthritis drug Humira  Sharenet2 days ago FDA approves Amgen's copy of AbbVie arthritis drug Humira  FOXNews.com3 hours ago UPDATE 1-U.S. FDA approves Amgen's copy of AbbVie arthritis drug Humira  Business Insider2 days ago
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FDA Issues Draft Guidance on Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices- Drug Information Update

The U.S. Food and Drug Administration has released a draft guidance document entitled Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices. This draft guidance is intended to help drug sponsors and device ...
 American Pharmaceutical Review3 days ago

AHIP Report Finds Orphan Drugs That are Used More Widely are More Costly

A report from America's Health Insurance Plans (AHIP) suggest that orphan drug designation from the U.S. Food and Drug Administration (FDA) has become a lucrative business opportunity for pharmaceutical companies. These medications made up almost ...
 ASH Clinical News1 week ago
Money Control

Marksans Pharma gets nod US FDA nod for Loratadine capsules

Marksans Pharma on Monday informed the exchanges that it has received approval from the US Food and Drug Administration for an ANDA for Loratadine liquid filled capsules 10 mg. Loratadine liquid filled capsules is an antihistamine that reduces the ...
 Hindu Business Line16 minutes ago Aurobindo Pharma receives USFDA tentative approval for Dolutegravir  Money Control4 days ago Glenmark gets USFDA nod for Xylocaine ointment  Money Control2 weeks ago Lupin gets tentative nod from USFDA for Silodosin capsules  Money Control2 weeks ago
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Business Line

Ibrutinib (IMBRUVICA®) Supplemental New Drug Application Submitted to the U.S. Food and Drug Administration (FDA) for Marginal Zone Lymphoma (MZL)

RARITAN, N.J. , Sept. 26, 2016 /PRNewswire/ --Janssen Research & Development, LLC announced today that a supplemental New Drug Application (sNDA) for ibrutinib (IMBRUVICA ® ) has been submitted to the U.S. Food and Drug Administration (FDA) for the ...
 BioSpace4 hours ago Supplements: Adding to the problem?  Business Line1 month ago Janssen Pharmaceutical Companies Release: Ibrutinib (IMBRUVICA) Supplemental New Drug Application Submitted To The FDA For Marginal Zone Lymphoma (MZL)  BioSpace1 hour ago AbbVie Announces Submission of a Supplemental New Drug Application for Ibrutinib (IMBRUVICA ®) for Treatment of Marginal Zone Lymphoma  Stockwatch5 hours ago
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Reuters India

Vela Diagnostics gets emergency U.S. authorization for Zika test

A view shows the U.S. Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland August 14, 2012. REUTERS/Jason Reed/File Photo Vela Diagnostics said its test for the Zika virus had received "emergency use authorization" from ...
 Reuters India2 hours ago Vela Diagnostics Gets FDA Emergency U.S. Authorization for Zika Test  BioSpace2 hours ago REUTERS - Vela Diagnostics gets emergency U.S. authorization for Zika test  Namibia Press Agency3 hours ago
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US FDA grants approval for Novartis' Ilaris to treat Periodic Fever Syndromes

Novartis has received the US Food and Drug Administration's (FDA) approval for Ilaris (canakinumab) to treat rare Periodic Fever Syndrome conditions. Periodic Fever Syndromes are a group of diseases that cause serious recurrent fever and ...
 Pharmaceutical Technology6 hours ago Novartis gets three FDA approvals for expanded use of biologic drug to treat rare autoinflammatory diseases  News-Medical.Net1 day ago Novartis receives US FDA approvals for expanded use of Ilaris treating rare Periodic Fever Syndrome conditions  PharmaBiz3 hours ago Too Late? FDA Criticized After Its Approval Of Drug For Boys Suffering From Rare Disease  Daily Caller6 days ago
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