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About 1179 results for "fda"

Sarepta says FDA will not complete eteplirsen NDA review by Th...

The FDA informs Sarepta Therapeutics (NASDAQ: SRPT ) that it needs more time to complete its review of the company's New Drug Application (NDA) seeking approval of eteplirsen for the treatment of patients with Duchenne muscular dystrophy amenable to ... Seeking Alpha, 13 minutes ago

2,097 images for fda, 8 hours ago
Business Standard, 2 hours ago
Yahoo! India, 7 minutes ago
Mumbai Mirror, 1 day ago, 21 hours ago
Food Safety Magazine, 19 hours ago
Package Printing, 20 hours ago
MedIndia, 4 days ago, 20 hours ago
News.Az, 2 hours ago

FDA Considering Pricey Implant As Treatment For Opioid Addiction

[embedded content] Amid a raging opioid epidemic, many doctors and families in the U.S. have been pleading for better treatment alternatives. One option now under consideration by the Food and Drug Administration is a system of implanted rods that ...
 Washington Post2 hours ago

BRIEF-Abeona says announces FDA allowance of IND for phase 1/2 clinical study

May 24 Abeona Therapeutics Inc * Abeona therapeutics announces fda allowance of investigational new drug (ind) for phase 1/2 clinical study with abo-101 gene therapy for patients with sanfilippo syndrome type b (mps iiib) Source text for Eikon: ...
 Reuters UK23 hours ago NLS Pharma Announces Submission of Investigational New Drug IND Application to FDA for Its Controlled-Release Mazindol for the Treatment of Adults...  Pharmacy Choice14 minutes ago ABEONA THERAPEUTICS : Announces FDA Allowance of Investigational New Drug (IND) for Phase 1/2 Clinical Study With ABO-101 Gene Therapy for Patients With Sanfilippo Syndrome Type B (MPS IIIB)  4 Traders1 day ago Abeona Therapeutics Announces FDA Allowance of Investigational New Drug (IND) for Phase 1/2 Clinical Study With ABO-101 Gene Therapy for Patients With Sanfilippo Syndrome Type B (MPS IIIB)  PipelineReview20 minutes ago
Monthly Prescribing Reference

FDA accepts Allergan's NDA for oxymetazoline HCl cream; action date H1 2017

The FDA accepts for review the New Drug Application (NDA) from Allergan (NYSE: AGN ) seeking approval of oxymetazoline HCl cream 1.0% for the treatment of persistent facial erythema (redness) associated with rosacea in adults. The FDA's action date ...
 Seeking Alpha23 hours ago FDA to Review Topical Rosacea Treatment  Monthly Prescribing Reference18 hours ago Allergan Announces FDA Acceptance of NDA Filing for Oxymetazoline HCI Cream 1.0%  ADVFN UK1 day ago Allergan's NDA filing for oxymetazoline HCl cream 1.0% accepted for review by the US FDA for facial erythema associated with rosacea in adults  Bloomberg36 minutes ago

FDA approves expanded label for Janssen Pharma's T2D med Invokamet

The FDA approves the use of Janssen Pharmaceuticals' (NYSE: JNJ ) INVOKAMET , a fixed-dose combination of INVOKANA (canagliflozin) and metformin hydrochloride, for first-line treatment of adults with type 2 diabetes (T2D). INVOKAMET was first ...
 Seeking Alpha22 hours ago FDA expands indication for Janssen Pharmaceuticals Invokamet diabetes drug  Pharmaceutical Business Review52 minutes ago FDA Expands Invokamet Label to Include First-Line Treatment of Adults With Type-2 Diabetes  PT Community16 hours ago U.S. FDA Expands Indication of INVOKAMETĀ® (canagliflozin/metformin HCl) to Include First-Line Treatment of Adults with Type 2 Diabetes  WorldNetDaily23 hours ago

Flatiron Health and the FDA Embark on Cancer Research Collaboration

NEW YORK--( BUSINESS WIRE )--Flatiron Health and the U.S. Food and Drug Administration (FDA) have signed a research collaboration agreement to determine how real-world evidence derived from de-identified, HIPAA-compliant patient data captured ...
 Business Wire5 minutes ago FDA warns Semler over research data  The Hindu1 month ago

FDA advisers offer unanimous backing for Novo's diabetes combo

An FDA advisory committee handed Novo Nordisk ($NOVO) a rousing endorsement for its diabetes combo IDegLira, voting 16 to 0 on Tuesday to back the company's marketing application. The vote came after FDA insiders raised a number of objections to ...
 FierceBiotech13 minutes ago IDegLira gets unanimous FDA advisory panel vote in favor of approval  Pharma Letter2 hours ago FDA advisory committee supports insulin degludec/liraglutide for type 2 diabetes  Healio11 hours ago IDegLira receives unanimous 16-0 vote in favor of approval from FDA Advisory Committee  PredictWallStreet11 hours ago

FDA delays decision on Sarepta's muscle-wasting disorder drug

May 25 (Reuters) - Sarepta Therapeutics Inc said it was notified by the U.S. Food and Drug Administration that a review of its muscle-wasting disorder drug would not be completed by Thursday. The FDA said it will continue to work past the goal date ...
 Sharenet15 minutes ago D-Day For Sarepta As FDA Decision Looms  Nasdaq8 hours ago Senators urge FDA to approve Sarepta drug for Duchenne  StatNews.com20 hours ago

FDA updates labelling on added sugars

Details Hits: 172 The U.S. Food and Drug Administration (FDA) has finalised the new Nutrition Facts label for packaged foods to reflect new scientific information, including the link between diet and chronic diseases such as obesity and heart ...
 GDPUK25 minutes ago FDA unveils the new Nutrition Facts label  Institute of Food Technologists10 hours ago FDA Finalizes Revisions to Nutrition/Supplement Facts Labeling  JD Supra16 hours ago Why the sugar industry hates the FDA's new nutrition facts label  PostGuam2 days ago
Business Standard

Zydus gets FDA nod to market anti-fungal drug

Email this Print Ahmedabad-based Zydus Cadila has received the final approval from the US drug regulator USFDA to market Voriconazole tablets in strengths of 50 mg and 200 mg. The drug, which is used for treatement of fungal infections, had ...
 Smart Investor2 hours ago Ajanta Pharma receives US FDA approval for migraine drug  Financial Express23 hours ago Ajanta Pharma's migraine drug, zolmitriptan receives US FDA approval  PharmaBiz1 day ago Ajanta Pharma announces the US FDA approval of Zolmitriptan Tablets (SCRIPCODE: 532331)  HT Syndication1 day ago
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