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About 191 results for "us fda"

Novartis gets FDA breakthrough status for Tafinlar, Mekinist c...

Novartis on Monday said the U.S. Food and Drug Administration has granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery. FILE PHOTO - A Novartis logo is ... Reuters, 1 hour ago

54 images for us fda

Money Control, 2 days ago
Money Control, 4 weeks ago
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Sify, 3 weeks ago
The Telegraph UK, 2 weeks ago
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US FDA issues guidelines to help generic makers to copy 32 complex drug products

US FDA has been trying to encourage competition in complex drugs through several initiatives. One of the major step is to issue new draft and revised guidance documents to provide product-specific clarity enabling generic makers to design appropriate ...
 Money Control2 days ago
Money Control

US FDA clears Sun Pharma's Dadra plant

Dadra is Sun Pharma's second-largest plant in India, and had received 11 adverse observations in a US FDA inspection in April
 Business Standard1 week ago Dr Reddy's strong drug pipeline comes to the fore  Business Standard1 month ago Dr Reddy's UK plant receives inspectional observations  Business Standard1 month ago US FDA makes 3 observations after inspecting Dr Reddy's UK plant  Business Standard1 month ago
Sify

BUZZ-India's Biocon gains; co says FDA letter not to hit US drug launch

** Shares in Biocon Ltd rise as much as 4.9 pct to361.20 rupees, their highest since Sept 22 ** Biocon says complete response letter (CRL) issued by U.S.FDA for proposed biosimilar Pegfilgrastim will not impact itscommercial launch timing in the United States ...
 Sify1 week ago Biocon slides on reports of US FDA observations  Sify2 months ago Indian shares fall; Reliance Industries, pharma stocks drag  Sify2 months ago US STOCKS-Wall St climbs to fresh highs after Tillerson's comments  Sify2 weeks ago

Neutral on Sun Pharma; women healthcare portfolio positive for Lupin: HDFC Securities

Sun Pharmaceutical Industries gets a breather; a sign of relief after the US Food and Drug Administration (US FDA) closed the inspection and gave a clean chit to their Dadra unit.
 Money Control1 week ago AcelRx Pharma shares sink as FDA rejects opioid painkiller  Reuters1 week ago Adamas Pharma secures approval for Parkinson's dyskinesia drug  Reuters1 month ago FDA approves leukemia treatment developed by Celgene, Agios  Reuters2 months ago
Money Control

BUZZ-India's Natco Pharma rises; U.S. FDA approves generic for multiple sclerosis

** India's Natco Pharma Ltd surges 20 pct to952.40 rupees to hit its upper circuit limit, the biggestintraday pct gain since July 29, 2013 ** U.S. marketing partner Mylan NV gets FDA approvalfor Natco's generic of multiple sclerosis treatment ...
 Sify2 weeks ago FDA nod to Natco's marketing partner Mylan for generic  Business Standard2 weeks ago Natco Pharma locked at 20% upper circuit as partner Mylan gets USFDA nod for multiple sclerosis drug  Money Control2 weeks ago
Money Control

Zydus Cadila gets final US FDA nod to market arthritis drugs

It will manufacture the drug at the Moraiya facility in Ahmedabad
 Business Standard3 weeks ago Cadila may gain after FDA clearance for Moraiya facility  Business Standard1 month ago Cadila among few bright spots in pharma space  Business Standard2 weeks ago Zydus gets USFDA nod to market anti-diuretic nasal spray  Business Standard2 weeks ago

US FDA issues 2 observations to Aurobindo#39;s Unit VI in Hyderabad

CNBC-TV18 has accessed the form 483 issued to Aurobindo Pharma#39;s Unit VI in Hyderabad.
 Money Control1 month ago Glenmark gains over 2.5% as US FDA issues no observations to Indore unit  Money Control1 month ago Granules India gains 10% after US FDA gives no observations to Gagillapur unit  Money Control2 months ago
Sify

BUZZ-India's Divi's Labs falls; U.S. FDA observations more than procedural -report

** Divi's Laboratories Ltd falls as much as 9.4pct to 870.1 rupees ** Observations issued by the U.S. FDA on its Visakhapatnamplant question data integrity and cite inadequate cleaningprocedure, news agency BloombergQuint reports (http://bit.ly/2hwaedM) ** ...
 Sify3 weeks ago Divi's Labs falls; US FDA observations more than procedural - report  Sify3 weeks ago
Med India

Flexion's knee pain drug gets FDA nod, shares hit life high

Flexion Therapeutics Inc said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration, sending the drug developer’s shares soaring to a record high in regular trading on Friday. The approval ...
 Reuters2 weeks ago FDA approves Abbott's blood glucose monitoring device  Reuters3 weeks ago FDA declines to approve Intellipharma's opioid painkiller  Reuters3 weeks ago U.S. FDA joins Interpol crackdown on illicit online pharmacies  Reuters3 weeks ago
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