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About 813 results for "us fda"

Vascular Solutions' New R350 Guidewire Gets FDA 510(k) Nod

Vascular Solutions' New R350 Guidewire Gets FDA 510(k) Nod

Vascular Solutions, Inc. VASC recently disclosed that its latest version of R350 guidewire has won the 510 (k) approval from the U.S. Food and Drug Administration (FDA). Following the release of this news, shares of this medical device manufacturer ..., 1 hour ago
DNA India

Drugmaker's shares plunge as FDA issues warning on India sites

NEW DELHI (NewsRise) -- Dr. Reddy's Laboratories plunged in Mumbai trading, extending its losses this month to more than a quarter of its value, after the U.S. health regulator published a letter that highlighted quality control problems at three of ...
 Nikkei Asian Review6 hours ago US FDA may ban Dr Reddy's imports on quality concerns  DNA India11 hours ago US FDA sounds import ban on Dr Reddy's drugs for several violations  Firstpost.com11 hours ago US drug cop warns DRL of import ban  Calcutta Telegraph18 hours ago

Dr Reddy's Shares Crash On Fresh US FDA Worries

, 10:14 [IST] Shares in Dr Reddy's crashed after the US FDA identified significant deviations at the plants of the company it had inspected. Earlier this month the company was issued a warning letter from the US FDA for these three plants.
 Oneindia11 hours ago Dr. Reddy's Declines in Mumbai After FDA Posts Warning Letter  Bloomberg13 hours ago DRL kept us in dark on lab: FDA  Deccan Chronicle20 hours ago US FDA note: Dr Reddy's did not have data protection system  Hindu Business Line1 day ago
Inside INdiana Business

Eli Lilly's Portrazza receives US FDA approval for metastatic squamous NSCLC

Eli Lilly and Company announced that the US Food and Drug Administration (FDA) has approved Portrazza (necitumumab injection for intravenous use, 800 mg/50 ml), in combination with gemcitabine and cisplatin, as the first biologic for the first-line ...
 PharmaBiz14 hours ago FDA approves Seqirus' Fluad for adults aged 65 years and older against seasonal influenza  Pharmaceutical Business Review3 hours ago US FDA approves Seqirus flu vaccine Fluad  Pharma Letter6 hours ago FDA Approves Portrazza  Advance for Respiratory Care & Sleep Medicine12 hours ago
Produce Grower

FDA Finalizes Genetically Engineered Food Labeling Guidance & Approves AquAdvantage Salmon

Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for use as human food ...
 National Law Review19 hours ago FDA Says Genetically Engineered Salmon Safe to Eat  HealthNewsDigest.com19 hours ago No need to label genetically engineered plants, FDA says  Produce Grower1 day ago Food for Thought: FDA Approves Genetically Engineered Salmon  JD Supra1 day ago

US FDA warns of serious data integrity violations at DRL

The US Food and Drug Administration has warned DRL over serious data integrity violations, placing all its new applications or supplements under a cloud The US Food and Drug Administration (US FDA) has warned Dr Reddy's Laboratories (DRL) over ...
 Financial Express5 hours ago
Pharma Letter

Amgen submits first adalimumab biosimilar application to the US FDA for various inflammatory diseases

Biotechnology company Amgen (NasdaqGS:AMGN) said on Wednesday that it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for ABP 501 for the treatment of various inflammatory diseases. This submission ...
 Bloomberg8 hours ago Amgen files for FDA approval of Humira biosimilar  Pharma Letter4 hours ago Amgen files for U.S. approval of biosimilar to Humira  US.NewsHub.org18 hours ago

Dr Reddy's reels under heat of US FDA action; stock down 10%

MUMBAI: Dr Reddy's Laboratories tumbled 10% in morning trade with investors dumping the stock as more detailed analysis emerged of warnings received earlier in the month from the US Food and Drug Administration over manufacturing practices. The US ...
 Economic Times9 hours ago

Indivior's nasal spray rejected by FDA

Pharma group Indivior said on Tuesday that the US Food and Drug Administration rejected its nasal spray for the emergency treatment of opioid overdose. The company is reviewing the health regulator's response. These sprays contain naloxone, a ...
 Irish Times18 hours ago FDA rejects Indivior's nasal spray for opioid overdose  Reuters India1 day ago FDA declines to approve Indivior's naloxone nasal spray for opioid overdose  Pharmaceutical Business Review1 day ago INDV's FDA fail  Stock Market Wire1 day ago

FDA Alerts On Compounded Vitamin Capsules Distributed By Glades Drugs

The U.S. Food and Drug Administration has alerted health care professionals and patients of a voluntary recall of compounded multivitamin capsules containing high amounts of Vitamin D3 (Cholecalciferol), distributed nationwide by Glades Drugs in ...
 RTTNews.com12 hours ago
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