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 The leading web portal for pharmacy resources, news, education and careers September 26, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 26, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
Current Articles | 7 - 30 Days Old | 30 - 90 Days Old | Over 90 Days
Articles(s): 1 - 25 of 93     Next >>     Go To Page:

9/25/17 - Actamax receives approval to begin pivotal clinical trial for Actamax Adhesion Barrier
Release date- 22092017- Actamax Surgical Materials LLC, a wholly owned subsidiary of DSM, focused on design of bioresorbable medical devices to reduce the burden of post-operative complications for patients undergoing surgery, announced it has received conditional approval of an Investigational Device Exemption from the US Food and Drug Administrat
9/25/17 - Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay
By a News Reporter-Staff News Editor at Pharma Business Week Agilent Technologies Inc. has announced that it has obtained 510 clearance from the U.S. Food and Drug Administration for the GenetiSure Dx Postnatal Assay: its first comparative genomic hybridization assay for diagnostic use. Previously available only in Europe, U.S. clinical genetic..
9/25/17 - Agilent Technologies Receives Expanded FDA Approval for the Use of Dako PD-L1 IHC 22C3 pharmDx Companion Diagnostic in Gastric or Gastroesophageal Junction (GEJ) Cancer
SANTA CLARA, Calif. Agilent Technologies Inc. today announced its Dako PD-L1 IHC 22 C3 pharmDx assay has an expanded label approved by U.S. Food and Drug Administration, for use as an aid in identifying gastric or GEJ adenocarcinoma patients for treatment with KEYTRUDA, an anti-PD-1 therapy manufactured by Merck& Co., Inc., Kenilworth, N.J., USA.
9/25/17 - Amphastar Announces Approval for Neostigmine Methylsulfate Injection, USP
Amphastar Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration granted approval of its abbreviated new drug application for Neostigmine Methylsulfate Injection, USP, 1 mg/mL, 10 mL, and 0.5 mg/mL, 10 mL vial. Amphastar s newly approved product was determined by the FDA to be therapeutically equivalent to Bloxiverz sol
9/25/17 - Amsel Medical Corporation Announces Clearance of a 510(k) Pre-Marketing Notification by the US Food and Drug Administration for the Low-Profile Amsel Occluder Device
Amsel Medical Corporation today announced clearance of a Pre-Marketing Notification by the US Food and Drug Administration for its Low-Profile Amsel Occluder Device 1. Arnold Miller, MD, Founder and President of Amsel Medical Corporation commented, We are thrilled about the clearance of the Pre-Market Notification by FDA for the Low-Profile Amse
9/25/17 - Bayer Receives FDA Approval for Aliqopa copanlisib 60 mg vial for Injection in Adults with Relapsed Follicular Lymphoma after Two Prior Systemic...
By a News Reporter-Staff News Editor at Clinical Trials Week Bayer announced that the U.S. Food and Drug Administration has approved Aliqopa? for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies.1 Accelerated approval was granted for this indication based on ORR. Aliqopa is a novel intrave
9/25/17 - BioCryst's RAPIVAB Receives FDA Approval for a Pediatric Indication
Release date- 22092017- RESEARCH TRIANGLE PARK- BioCryst Pharmaceuticals, Inc. a biotechnology company focused on the development and commercialization of treatments for rare and infectious diseases, announced today that the U.S. Food and Drug Administration has approved a supplemental New Drug Application for RAPIVAB, an intravenous neuraminidase.
9/25/17 - Boston Scientific Announces U.S. FDA Approval for MRI Labeling on High-Voltage Devices and U.S. Launch of Resonate? Devices with the HeartLogic? Heart Failure Diagnostic
Boston Scientific has launched the Resonate? family of implantable cardioverter defibrillator and cardiac resynchronization therapy defibrillator systems featuring the HeartLogic? Heart Failure Diagnostic to help physicians improve heart failure management. The new devices, which are approved by the U.S. Food and Drug Administration for...
9/25/17 - Bracco Diagnostics Inc. Receives U.S. FDA Approval for TAGITOL? V (Barium Sulfate) Oral Suspension
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, today announced that the U.S. Food and Drug Administration approved TAGITOL V oral suspension for use in adult patients undergoing a CTC. In 2016, the United States Preventive Service Task Force included CTC in its r
9/25/17 - Cerapedics Announces Publication of Two-Year IDE Study Follow-Up Data on i-FACTOR Bone Graft in the Cervical Spine
By a News Reporter-Staff News Editor at Clinical Trials Week Cerapedics, a privately-held orthobiologics company, announced the publication of two-year follow-up data from an FDA Investigational Device Exemption clinical trial of i-FACTOR? Peptide Enhanced Bone Graft. In November 2015, Cerapedics received Premarket Approval from the FDA for the
9/25/17 - China Food and Drug Administration Approves Gilead's Sovaldi (Sofosbuvir) for Treatment of Chronic Hepatitis C Virus Infection
Gilead Sciences, Inc. announced today that the China Food and Drug Administration has approved Sovaldi , a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus infection. The approval of Sovaldi is supported by a Phase 3 study conducted in China, presented earlier this year at the Asian Pacific Ass
9/25/17 - CSL Behring Announces FDA Approval of Privigen [Immune Globulin Intravenous Human, 10% Liquid] for the Treatment of Chronic Inflammatory...
By a News Reporter-Staff News Editor at Pharma Business Week Global biotherapeutics leader CSL Behring announced that the U.S. Food and Drug Administration has approved Privigen for the treatment of adults with chronic inflammatory demyelinating polyneuropathy to improve neuromuscular disability. "The FDA approval of Privigen for CIDP represe
9/25/17 - Douglas Medical Products Inc. Receives FDA 510k Clearance for the TUBETECH IV Administration Set
By a News Reporter-Staff News Editor at Pharma Business Week Douglas Medical Products, Inc., a growing medical device company focused on contract manufacturing of IV Administration/ Extension Sets and Enteral Sets, announced that it has received 510 clearance for TUBETECH IV Administration Sets from the U.S. Food and Drug Administration.
9/25/17 - FDA Approves Amgen And Allergan's MVASI bevacizumab-awwb For The Treatment Of Five Types Of Cancer
By a News Reporter-Staff News Editor at Clinical Trials Week Amgen and Allergan plc. announced that the U.S. Food and Drug Administration has approved MVASI? for all eligible indications of the reference product, Avastin . "The approval of MVASI marks a significant milestone for healthcare practitioners and patients as the first anti-cancer
9/25/17 - FDA Approves Two Ortho Clinical Diagnostics Specialty Hepatitis B Assays
By a News Reporter-Staff News Editor at Hepatitis Weekly Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, has received approval from the U.S. Food and Drug Administration for Ortho's VITROS Immunodiagnostic Products HBeAg Assay and the VITROS Immunodiagnostic Products Anti-HBe Assay for use on Ortho's VITROS 3600...
9/25/17 - Gilead Sciences Announces Approval Of Sofosbuvir In China
FOSTER CITY- Gilead Sciences, Inc. announced the China Food and Drug Administration has approved Sovaldi, a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus infection. Sovaldi received marketing approval from the U.S. FDA in 2013 and the European Commission in 2014. It is also approved for use in
9/25/17 - GSK's Shingrix containing Agenus' QS-21 Stimulon adjuvant receives Unanimous FDA Advisory Committee recommendation for approval
By a News Reporter-Staff News Editor at Clinical Trials Week Agenus Inc., an immuno-oncology company with a pipeline of immune checkpoint antibodies and cancer vaccines, announced that GlaxoSmithKline's shingles vaccine candidate, Shingrix, containing Agenus' proprietary immune adjuvant, QS-21 Stimulon , was unanimously recommended for approval
9/25/17 - Lupin receives USFDA approval for generic Clobex Lotion [India Infoline News Service]
Lupin announced that it has received final approval for its Clobetasol Propionate Lotion, 0.05% from the United States Food and Drug Administration Lupin announced that it has received final approval for its Clobetasol Propionate Lotion, 0.05% from the United States Food and Drug Administration to market a generic version of Clobex Lotion, 0.05%, t
9/25/17 - New indication for BRIVIACT brivaracetam: UCB's newest antiepileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in...
By a News Reporter-Staff News Editor at Clinical Trials Week UCB announced that the U.S. Food and Drug Administration has approved a supplemental new drug application for BRIVIACT CV as monotherapy for partial-onset seizures in patients 16 years and older with epilepsy.1. This is a new indication for BRIVIACT, which is already approved in the
9/25/17 - Perrigo Announces FDA Final Approval For Its AB Rated Generic Version Of Exalgo 32mg Extended Release Tablets
Release date- 22092017- DUBLIN- Perrigo Company plc today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Exalgo 32 mg extended release tablets. Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by
9/25/17 - Seqirus Receives FDA Approval of AFLURIA QUADRIVALENT Influenza Vaccine for People Five Years of Age and Older in the U.S.
By a News Reporter-Staff News Editor at Pharma Business Week Seqirus announced that the U.S. Food and Drug Administration has approved AFLURIA QUADRIVALENT for use in people five years of age and older, extending the company's broad portfolio of influenza vaccine offerings. AFLURIA QUADRIVALENT, which was first approved in the U.S. in August 2016
9/25/17 - Sun Pharma Odomzo New Label Approval
Release date- 22092017- Mumbai- Sun Pharmaceutical Industries Ltd. today announced that one of its wholly owned subsidiaries has received approval from the US Food and Drug Administration for a new label for Odomzo, an oral hedgehog inhibitor indicated for the treatment of patients with locally advanced basal cell carcinoma that has recurred follow
9/25/17 - Sunovion's Aptiom eslicarbazepine acetate Receives FDA Approval for Expanded Indication to Treat Partial-Onset Seizures in Children and Adolescents...
By a News Reporter-Staff News Editor at Pharma Business Week Sunovion Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application to expand the indication for its antiepileptic drug Aptiom to include treatment of partial-onset seizures in children and adolescents four to 17 years of
9/24/17 - Investigational IPF Therapy Gets FDA Go Ahead
An oral anti-fibrotic drug candidate, PBI-4050, has received FDA Investigational New Drug approval to commence a Phase 2/3 clinical trial in patients with idiopathic pulmonary fibrosis (IPF).
9/23/17 - Actelion Receives FDA Approval Of TRACLEER bosentan For Use In Pediatric Patients With Pulmonary Arterial Hypertension
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week Actelion Pharmaceuticals US, Inc., one of the Janssen Pharmaceutical Companies of Johnson& Johnson, announced that the U.S. Food and Drug Administration has approved a new 32 mg tablet for oral suspension for TRACLEER for use in pediatric patients aged three years and olde
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