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Tag: usfda

You Searched For "usfda"
FDA approves first emergency treatment for chemotherapy overdose

FDA approves first emergency treatment for chemotherapy overdose

savita14 Dec 2015 11:49 AM IST
The U.S. Food and Drug Administration approved Vistogard (uridine triacetate) for the emergency treatment of adults and children who receive an...
US-Based Acorda Therapeutics in Settlement Pact With Aurobindo Pharma

US-Based Acorda Therapeutics in Settlement Pact With Aurobindo Pharma

Pooja14 Dec 2015 10:20 AM IST
Hyderabad: US-based biotechnology company Acorda Therapeutics has said it entered into a settlement agreement with Aurobindo Pharma to...
Roche gets accelerated U.S. approval for lung cancer drug

Roche gets accelerated U.S. approval for lung cancer drug

Meghna A Singhania13 Dec 2015 2:55 PM IST
U.S. health regulators on Friday said they have granted accelerated approval to Roche Holding's drug for advanced lung cancer in patients with a...
Sharon receives EIR report from USFDA on inspection closure

Sharon receives EIR report from USFDA on inspection closure

savita13 Dec 2015 2:52 PM IST
New Delh: Drug firm Sharon Bio-Medicine said it has received the establishment inspection report (EIR) from the USFDA on closure of inspection of its...
FDA approves Genentech drug for advanced lung cancer

FDA approves Genentech drug for advanced lung cancer

savita13 Dec 2015 2:39 PM IST
The Food and Drug Administration has approved an experimental Genetech drug for patients with a certain type of lung cancer who have few other...
FDA approves new oral therapy to treat ALK-positive lung cancer

FDA approves new oral therapy to treat ALK-positive lung cancer

Pooja12 Dec 2015 9:29 AM IST
The U.S. Food and Drug Administration today approved Alecensa (alectinib) to treat people with advanced (metastatic) ALK-positive non-small cell lung...
Shortage of drug inspectors hurting pharma exports:Assocham

Shortage of drug inspectors hurting pharma exports:Assocham

Pooja11 Dec 2015 12:57 PM IST
Indian pharmaceutical sector is facing regulatory hurdles in the international markets, including the US, due to shortage of skilled drug inspectors,...
Aurobindo gets USFDA nod to market heart disease drug

Aurobindo gets USFDA nod to market heart disease drug

savita10 Dec 2015 12:45 PM IST
NEW DELHI: Aurobindo Pharma has received US health regulator's approval to market Eptifibatide Injection, used in the treatment of acute coronary...
Aurobindo Pharma gets USFDA nod for oral contraceptive tablets

Aurobindo Pharma gets USFDA nod for oral contraceptive tablets

savita10 Dec 2015 11:15 AM IST
NEW DELHI: Drug firm Aurobindo Pharma has received final approval from the US health regulator to manufacture and market its oral contraceptive...
FDA Clears Cold Cap To Save Hair During Breast Cancer Chemotherapy

FDA Clears Cold Cap To Save Hair During Breast Cancer Chemotherapy

Pooja10 Dec 2015 9:52 AM IST
WASHINGTON (AP) -Hair loss is one of the most despised side effects of chemotherapy, and now breast cancer patients are getting a new way to try to...
Dr Reddy

Dr Reddy's submits response to USFDA over warning letter

savita9 Dec 2015 11:31 AM IST
New Delhi: Dr Reddy's Laboratories has submitted a response to the US health regulator on a warning letter it had received last month."We would like...
Unichem Laboratories receives USFDA approval for hypertension drug

Unichem Laboratories receives USFDA approval for hypertension drug

Pooja9 Dec 2015 10:40 AM IST
Unichem Laboratories has received the approval from USFDA for Irbesartan tablets USP indicated to treat hypertension. The product will be...
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