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About 1227 results for "fda"

Merck Announces New FDA-Approved Guidelines for HPV Vaccine
Med India

Get off the fence, FDA, and deal with generic labeling

Im not a fanatical cheerleader for the pharma and biotech industry—nor for government agencies like the U.S. Food and Drug Administration (though I admit to a huge soft spot for the National Institutes of Health). And frankly, that's a good thing, ... Drug Discovery News, 30 minutes ago

1,546 images for fda, 10 hours ago
MedIndia, 8 hours ago
Review Seeker, 2 hours ago
Bidness Etc, 3 hours ago
MassDevice, 22 hours ago
Fox28 WSJV, 1 day ago
Fox28 WSJV, 1 day ago
Occupational Health & Safety, 5 hours ago
Fox28 WSJV, 1 day ago
International Business Times India, 9 hours ago

FDA clears Dr. Reddy's betamethasone spray for psoriasis

The FDA clears Promius Pharma's Sernivo (betamethasone dipropionate) Spray, 0.05%, a topical steroid for the treatment of adults with mild-to-moderate plaque psoriasis. The commercial launch will commence next quarter. Promius is the U.S. wholly ...
 Seeking Alpha1 day ago Promius' Sernivo Spray gets FDA approval to treat moderate plaque psoriasis  Pharmaceutical Technology1 day ago Injectable migraine treatment gets FDA approval  European Pharmaceutical Manufacturer9 hours ago Dr.Reddy's gets FDA nod for anti-psoriasis spray [Mint, New Delhi]  Bloomberg1 day ago
Bidness Etc

CTI BioPharma Corp Dives Hard on Partial Clinical Hold by the FDA

CTI BioPharma Corp. ( NASDAQ:CTIC ) stock crashed today, after the Food and Drug Administration (FDA) placed a partial clinical hold on its pacritinib studies. The shares are down more than 50% during early trading hours. On February 4, the ...
 Bidness Etc5 hours ago FDA Puts CTI BioPharma, Baxalta PERSIST-2 Trial on Partial Hold  Pharmaceutical Manufacturing Magazine2 hours ago Adaptimmune Receives Breakthrough Designation From FDA  24/7 Wall St3 hours ago FDA places clinical studies of CTI Bio's lead product candidate on partial clinical hold due to excess mortality; shares drop 27% premarket  Seeking Alpha1 day ago

Epizyme passes US FDA orphan drug status for tazemetostat for treatment of malignant rhabdoid tumors (MRTs)

Biopharmaceutical company Epizyme (NasdaqGS:EPZM) revealed on Monday that it has received US Food and Drug Administration (FDA) orphan drug status for its first-in-class EZH2 inhibitor, tazemetostat, for the treatment of malignant rhabdoid tumors ...
 Bloomberg10 hours ago Epizyme's Tazemetostat granted FDA Orphan designation for malignant rhabdoid tumors  Center Watch4 hours ago Spinal Cord Injury Treatment Receives FDA Orphan Drug Designation  Rehab Manegement15 hours ago Epizyme Announces Tazemetostat Granted Orphan Drug Designation for Malignant Rhabdoid Tumors by U.S. FDA  Digital Journal1 day ago
Libya News Today

FDA Delays Decision on Muscular Dystrophy Drug Eteplirsen

The FDA has informed Sarepta Therapeutics that it will require additional time to complete its review of the new drug application (NDA) for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The ...
 P&T Community2 hours ago FDA announces recall of drug products  Manila Bulletin2 hours ago FDA extends action date for review of Sarepta's eteplirsen NDA to May 26  Seeking Alpha1 day ago Sarepta says FDA delays decision on muscle-wasting disorder drug  Reuters1 day ago

FDA Considers Labeling Update for Schizophrenia Drug Brexpiprazole (Rexulta)

The FDA has accepted for review a supplemental new drug application (sNDA) for a proposed labeling update of brexpiprazole (Rexulta, Otsuka/Lundbeck) for the maintenance treatment of adults with schizophrenia. The Prescription Drug User Fee Act ...
 P&T Community2 hours ago FDA accepts Otsuka and Lundbeck's sNDA for expanded use of REXULTI  Seeking Alpha1 day ago BRIEF-Lundbeck says FDA accepts sNDA application for Rexulti labelling  Reuters UK1 day ago FDA to Review Rexulti as Maintenance Therapy for Schizophrenia  Monthly Prescribing Reference23 hours ago

BRISTOL MYERS SQUIBB : receives approval from US FDA for Daklinza hepatitis C treatment

Bristol-Myers Squibb, a global biopharmaceutical company, has received approval from the US Food and Drug Administration for its hepatitis drug, Daklinza (daclatasvir), an NS5A replication complex inhibitor for expanded use, it was reported ...
 4 Traders11 hours ago FDA Denies Vertex's Application for Expanded Use of Cystic Fibrosis Drug  HT Syndication1 day ago Bristol-Myers' Daklinza-Sovaldi Label Expanded by the FDA  Zacks.com23 hours ago FDA approves Bristol Myers Squibb's Daklinza's for expanded use to treat patients with hepatitis C  Pharmaceutical Business Review1 day ago

LifeWatch wins FDA nod for vital sign monitoring

Swiss remote diagnostic monitoring company LifeWatch said today it received FDA 510(k) clearance for its Vital Signs monitoring service. The service operates using wireless, patch-based vital signs monitors to allow for early detection of vital ...
 MassDevice2 hours ago Startup raises $7M, adds execs for FDA-reviewed, antibacterial hospital scrubs  FierceMedicalDevices3 hours ago FDA Needs Help from Medtronic, St. Jude Medical on Leadless Pacers  BioSpace4 hours ago Hospitals, CMS rail against update to FDA device safety reports amid duodenoscope pushback  FierceMedicalDevices4 hours ago

FDA to make sweeping review of opioids policies

A box of the overdose antidote Naloxone Hydrochloride sits on a counter at a Walgreens store. Dr. Robert Califf, the FDA's Deputy Commissioner for Medical Products and Tobacco, along with other FDA leaders, have called for a far-reaching action ...
 Examiner.com21 hours ago FDA Officials Call for Review of Agency's Opioid Policies  PT Community1 day ago Changing course: A new approach to opioid pain medication at FDA  Pharmacist.com1 day ago Califf, FDA top officials call for sweeping review of agency opioids policies  World Pharma News1 day ago
The Nation Pakistan

In five years, US FDA rejected 13,334 Indian products

BENGALURU: As many as 13,334 products made in India were rejected by the US Food and Drug Administration (FDA) between 2010 and 2015 FDA data shows. During the period, it rejected imports of 15,087 Chinese products. According to the ministry of ...
 Economic Times12 hours ago 13,000 made-in-India products rejected by US-FDA in 6 years  Times of India17 hours ago In 5 years, US FDA rejected 13,000 Indian products  Times of India22 hours ago
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