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About 1060 results for "us fda"

Claris announces receipt of EIR from the US FDA
United News of India

Claris announces receipt of EIR from the US FDA

Mumbai, May 30 (UNI) One of India's largest sterile Injectables company, Claris Lifesciences Limited today said that it has received the Establishment Inspection Report (EIR) for its manufacturing facility located near Ahmedabad, wherein the US FDA ... United News of India, 12 minutes ago

407 images for us fda

Boston Globe, 2 days ago
Forwardgeek, 4 days ago
Broadway World, 4 days ago, 2 weeks ago
Business Insider, 3 days ago
Reuters UK, 3 days ago
The Hindu, 3 weeks ago
International Business Times, 3 days ago
Tech Times, 1 day ago
Libya News Today, 3 days ago
Monthly Prescribing Reference

FDA advisory committee recommends approval of Sanofi treatment for adults with type 2 diabetes

Sanofi announced today that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the U.S. Food and Drug Administration (FDA) recommended the approval of the New Drug Application (NDA) for the investigational fixed-ratio combination ...
 Bionity.com1 hour ago US FDA's EMDAC recommends approval of Sanofi's NDA to treat type II diabetes  Pharmaceutical Technology2 days ago PFO Occluder for Cryptogenic Stroke Recommended by FDA Panel  Diagnostic & Invasive Cardiology2 days ago FDA Panel Recommends Combo Injectable for Diabetes  Monthly Prescribing Reference2 days ago

CSL Behring receives FDA approval to treat haemophilia A

CSL Behring has received approval from the US Food and Drug Administration (FDA) for the use of its recombinant factor VIII single-chain therapy, Afstyla, as a treatment for haemophilia A. Hemophilia A is a congenital bleeding disorder that causes ...
 Pharmaceutical Technology2 days ago
Tech Times

FDA Approves Monthly Zinbryta Injection For Patients With Multiple Sclerosis

The U.S. FDA approved the monthly use of Zinbryta injectables for patients with relapsing multiple sclerosis. The approval came after two successful clinical trials. ( Jochen Pippir | Pixabay ) Patients with multiple sclerosis (MS) can now ...
 Tech Times1 day ago FDA approves new Biogen multiple sclerosis drug  Boston Globe2 days ago Zinbryta gets FDA approval for treating adults with relapsing forms of MS  News-Medical.Net2 days ago FDA Approves Zinbryta (daclizumab) to Treat Multiple Sclerosis  Drugs.com2 days ago
United News of India

Hyderabad-based Granules plant receives EIR from US FDA

Hyderabad, May 30 (UNI) Granules India Ltd., a growing pharmaceutical manufacturing company, announced today that it has received the Establishment Inspection Report (EIR) from the US FDA for the inspection conducted at its Jeedimetla facility in ...
 United News of India5 minutes ago Granules India gets EIR from the US FDA for Jeedimetla plant  Religare Securities42 minutes ago Orchid Pharma receives EIR from US FDA for Kancheepuram facility  India Infoline1 month ago Dahej plant receives EIR from US FDA:Torrent Pharma  India Infoline2 months ago

US FDA grants Fast Track Designation to Novavax's RSV F Vaccine

The US Food and Drug Administration (FDA) has granted Fast Track Designation to Novavax's respiratory syncytial virus (RSV) F-Protein nanoparticle vaccine candidate (RSV F Vaccine) that can be used to protect older adults of 60 years of age and ...
 CPhI.cn7 minutes ago U.S. FDA Grants Fast Track Designation to Novavax RSV F Vaccine for Older Adults  BioSpace4 days ago BRIEF-Indivior says U.S. FDA grants fast track designation for drug for opioid use disorder  Reuters UK3 days ago FDA Grants Fast Track Designation to Novavax's RSV F Vaccine for Older Adults  Advance for Respiratory Care & Sleep Medicine4 days ago

BioPharma Services Awarded FDA Contract

Spans 5-years and is worth $20 million BioPharma Services USA has been awarded a 5-year, $20 million contract with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA). The contract is to ...
 Contract Pharma2 days ago BioPharma Services USA, Inc. Awarded a 5 Year $20 Million USD Contract with the US FDA  4 Traders1 week ago
ABC News

FDA Approves Implant to Fight Opioid...

An implantable treatment for opioid addiction was approved today by the U.S. Food and Drug Administration, adding a new option in the fight against a growing epidemic. The implant, a match-sized rod that is inserted under the skin, releases a ...
 ABC News1 day ago FDA Approves Buprenorphine Implant For Opioid Addiction  Science World Report20 hours ago Implant to curb opioid addiction approved by FDA  WCVB.com2 days ago 5/27/16 - FDA approves anti-addiction implant to prevent opioid dependence  Pharmacy Choice2 days ago
Digital Journal

FDA's FSVP rule has an ambitious agenda

Of the seven rules the U.S. Food and Drug Administration (FDA) has issued under the 2011 Food Safety Modernization Act (FSMA), the one regarding (FSVP) is particularly ambitious. It attempts a number ofthings never done before with respect to the ...
 Before It's News3 hours ago FDA — One case may change recall procedure for online food sales  Digital Journal1 day ago FDA Issues New Food Safety Rule That Prevents Adulteration  RTTNews.com2 days ago FDA finalizes new food reserve order to forestall wide-scale open health harm  HealthMediciNet.com2 days ago

FDA rejects AstraZeneca hyperkalaemia drug

AstraZeneca Plc has received a complete response letter (CRL) from the US Food and Drug Administration rejecting its application to market a new drug for hyperkalaemia called ZS-9. The CRL relates to an unspecified manufacturing issue. Location ...
 MedNous23 hours ago AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA  Pharmafile2 days ago UPDATED: AstraZeneca's $2.7B hyperkalemia drug ZS-9 rejected by FDA  FierceBiotech3 days ago FLASH: AstraZeneca gets CRL from US FDA for ZS-9  Stock Market Wire3 days ago
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