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About 237 results for "us food and drug administration"

Natco Pharma gets USFDA nod for Armodafinil tablets
Money Control

Aurobindo Pharma in spotlight after securing USFDA approval fo...

Aurobindo Pharma announced that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Levetiracetam in Sodium Chloride Injection, 500 mg/100 mL (5 mg/mL), 1000 mg/100 mL (10 mg/mL), and 1500 mg/100 mL ... Business Standard, 1 month ago
Lupin gets USFDA nod to market its skin cream Business Standard, 1 month ago

1,398 images for us food and drug administration

Reuters, 6 days ago, 2 weeks ago, 4 weeks ago, 2 weeks ago, 2 weeks ago
Reuters, 2 weeks ago
PharmaVOICE, 1 month ago
CNN, 2 weeks ago
Yahoo! News, 1 month ago
PharmaVOICE, 2 months ago

Biocon chief sees anti-cancer biosimilar launch in FY19

Biocon Thursday announced the US Food and Drug Administration has accepted Mylan’s Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and ...
 Money Control5 days ago Biocon scales record high as USFDA accepts BLA for proposed biosimilar Trastuzumab  Business Standard1 month ago US nod for Biocon-Mylan biosimilar  Business Line1 month ago Biocon up 3% as USFDA accepts Trastuzumab license application  DNA1 month ago

FDA approves Valeant's drug to treat plaque psoriasis

The U.S. Food and Drug Administration on Wednesday approved Valeant Pharmaceuticals International Inc's Siliq to treat adults with moderate-to-severe plaque psoriasis. Psoriasis is an autoimmune disorder that occurs more commonly in patients with a family ...
 Reuters6 days ago Lawmakers question pricing of drug for genetic disease  Business Standard1 week ago FDA approves drug to treat Duchenne muscular dystrophy  Reuters1 week ago FDA approves Amgen drug for secondary hyperparathyroidism  Reuters2 weeks ago

FDA nod for anti-migraine drug to lift US revenues: Panacea

The company Wednesday received the US Food and Drug Administration (USFDA) approval for an anti-migraine drug for which it had filed the Abbreviated New Drug Application (ANDA) in 2012.
 Money Control1 month ago Ajanta Pharma slumps to over 6-1/2-month low over US FDA drug ban  Sify4 weeks ago Panacea Biotec Limited  Business Line1 month ago Panacea Biotec up 13 pct on US FDA nod for migraine drug  Business Standard1 month ago
Money Control

USFDA raises issues over Natco Pharma’s formulations plant

The US Food and Drug Administration (USFDA) has raised some issues after inspection of its Kothur formulations facility. The inspection was conducted in the Kothur plant near here during January 16-24, 2017. At the end of the inspection, the facility received ...
 Business Line4 weeks ago Hikal gallops as USFDA issues zero observations after inspection of Jigani plant  Business Standard1 month ago Wockhardt shares recover; ends marginally down  India Infoline1 month ago USFDA issues warning letter to Wockhardt's Ankleshwar plant  Money Control1 month ago

US FDA observations on Natco Pharma's Hyderabad facility

on Wednesday said it has been handed six observations by the US Food and Drug Administration for its facility at Kothur, near Hyderabad. The observations follow an inspection of the facility between January 16 and 24, the company said. The observations were ...
 Business Line3 weeks ago Alkem Labs gets EIR from USFDA for Daman facility  Business Standard2 months ago Alkem gets 3 FDA observations post Ankleshwar unit inspection  Business Standard2 months ago FDA made 9 observations post Halol unit inspection: Sun Pharma  Business Standard2 months ago
Money Control

Plants of Pharma major, Dr. Reddy's to be re-audited by USFDA

US Food and Drug Administration (USFDA) will re-audit three manufacturing plants of Dr. Reddy's Laboratories. After finding several violations with regard to current goods manufacturing practices (CGMPs), US Food and Drug Administration (USFDA) had sent them ...
 India Infoline1 month ago USFDA to re-audit three Dr Reddy's plants  Money Control1 month ago USFDA to re-audit Dr Reddy's 3 plants  Business Standard1 month ago

FDA approves generic version of Jazz Pharma's sleep disorder drug

The U.S. Food and Drug Administration said on Tuesday it had approved the first generic version of Xyrem, Jazz Pharmaceuticals Plc's drug to treat patients with a medical condition that causes excessive daytime sleepiness. ( Jazz Pharma's ...
 Reuters1 month ago Natco may launch leukemia drug in US mkt on or before Nov 2019  Business Standard1 month ago Natco may launch leukaemia drug in US mkt on or before Nov 2019  Business Line1 month ago

U.S. FDA nod for Natco’s generic Budesonide pills

Natco Pharma Ltd on Thursday said it had received final approval from the U.S. Food and Drug Administration for the Abbreviated New Drug Application it had filed for the generic version of Budesonide capsules. NATCO and its marketing partner Alvogen plan to ...
 The Hindu2 months ago Natco Pharma launches Tamiflu generic capsules in US  Money Control2 months ago NATCO receives final approval for generic Armodafinil tablets for USA market  India Infoline2 months ago

Indian American could be FDA head under Trump

Indian-American biotech entrepreneur Balaji Srinivasan is being considered for a role in the U.S. Food and Drug Administration (FDA) under President Donald Trump, the transition team said.Mr. Sriniva...
 The Hindu1 month ago Indian American on Trump probables list for USFDA chief  Business Line1 month ago
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