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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)
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Articles(s): 1 - 25 of 213     Next >>     Go To Page:

9/18/17 - 5 Stocks To Watch For September 18, 2017
Wall Street expects Steelcase Inc. to post quarterly earnings at $0.23 per share on revenue of $759.83 million after the closing bell. Steelcase shares gained 1.79 percent to close at $14.25 on Friday. Neos Therapeutics Inc disclosed that it has received the FDA approval for Adzenys ER. Scorpio Tankers shares dropped 2.23 percent to close at $3.50
9/18/17 - BioPhotas Inc. Clears Additional FDA and Intellectual Property Hurdles
By a News Reporter-Staff News Editor at Clinical Trials Week BioPhotas, Inc. announced the FDA clearance of the Celluma, its award-winning and patented medical device, for an additional indication-for-use in treating full face wrinkles. The FDA has previously cleared the Celluma for eight separate indications-for-use, including the treatment of..
9/18/17 - Braeburn Announces FDA Acceptance with Priority Review of New Drug Application for CAM2038 Buprenorphine Depot for the Treatment of Opioid Use Disorder
Braeburn Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration has accepted its New Drug Application with Priority Review designation for CAM2038, an investigational buprenorphine weekly and monthly depot injection for the treatment of adults with opioid use disorder. "FDA's acceptance of our NDA for CAM2038 under Priority R
9/18/17 - eNeura, Inc. Receives FDA Clearance for Use of SpringTMS for Migraine Prevention
By a News Reporter-Staff News Editor at Pharma Business Week eNeura, Inc., a privately held medical technology company, announced that it has obtained 510 clearance from the U.S. Food and Drug Administration that states: "The eNeura Spring TMS is indicated for the acute and prophylactic treatment of migraine headache." With this FDA clearance the
9/18/17 - FDA Approves Guerbet's Dotarem gadoterate meglumine for Pediatric Patients Younger Than Two Years
By a News Reporter-Staff News Editor at Pharma Business Week Guerbet LLC USA, the US affiliate of the global specialist in contrast products and solutions for medical imaging, announced that the US Food and Drug Administration has approved Dotarem for intravenous use with magnetic resonance imaging in pediatric patients under two years old, in
9/18/17 - FDA Approves Symbiomix Therapeutics Solosec? (secnidazole) Oral Granules for the Treatment of Bacterial Vaginosis in Adult Women
Symbiomix Therapeutics today announced the U.S. Food and Drug Administration has approved Solosec? 2 g oral granules for the treatment of bacterial vaginosis in adult women. Solosec? is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.. BV is the most prevalent gynecologic infection in the U.S
9/18/17 - FDA grants accelerated approval to new drug for treating relapsed follicular lymphoma [Syrian Arab News Agency]
For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments, said Richard Pazdur, M.D., director of the FDAs Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDAs Center for Drug Evaluation and Research. The National Cancer Institute at the Nati
9/18/17 - Medtronic Announces FDA Approval and U.S. Launch of Next Generation Spinal Cord Stimulator for Chronic Pain Management
The Intellis Platform Includes the World's Smallest Implantable Spinal Cord Stimulator and Offers Personalized Pain Relief and Advanced Activity Tracking DUBLIN- September 18, 2017- Medtronic plc today announced FDA approval and U.S. launch of the Intellis (TM) platform for the management of certain types of chronic intractable pain.
9/18/17 - Optinose Announces FDA Approval of XHANCE? (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps
Optinose, an ENT/ Allergy specialty pharmaceutical company, announced today that the U.S. Food& Drug Administration approved the Company s New Drug Application for XHANCE for the treatment of nasal polyps in patients 18 years of age and older. It is estimated that up to 10 million Americans suffer from nasal polyps and the symptoms that accompan
9/18/17 - Option Care a National Home Infusion Provider of First ALS Drug Approved by the FDA in More Than 20 Years
By a News Reporter-Staff News Editor at Pharma Business Week Option Care Enterprises, Inc., the nation's largest independent provider of home and alternate treatment site infusion services, has signed an agreement to become a national contracted home infusion provider for RADICAVATM, an intravenous infusion treatment for amyotrophic lateral scler
9/18/17 - Perrigo Announces Tentative FDA Approval For The Generic Version Of Acanya Gel
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Acanya topical gel 1.2%/ 2.5%. Perrigo previously settled litigation with Dow Pharmaceutical Sciences, Inc. and Valeant Pharmaceuticals North America LLC for this product. Perrigo Company plc, a leading g
9/18/17 - Sanofi Receives Tentative FDA Approval of Admelog insulin lispro injection 100 Units/mL
By a News Reporter-Staff News Editor at Diabetes Week Sanofi announced that the U.S. Food and Drug Administration granted tentative approval for Admelog 100 Units/mL, a rapid-acting human insulin analog. "Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," said Stefan Oelr
9/18/17 - Sobi Receives Approval From the FDA for Once-Daily Dosing Frequency of Orfadin nitisinone for the Treatment of HT-1
Orfadin is the first nitisinone product approved for once daily use in the U.S. This is an important step towards reducing the treatment burden of people with HT-1 and it follows Sobi's introduction of Orfadin 20 mg capsules and Orfadin oral suspension, "says Milan Zdravkovic, Senior Vice President, Chief Medical Officer, and Head of Research& Deve
9/18/17 - Trelegy Ellipta Approved as the First Once-Daily Single Inhaler Triple Therapy for the Treatment of Appropriate Patients with COPD in the US
GlaxoSmithKline plc and Innoviva, Inc. today announced that the US Food and Drug Administration has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol, under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease,...
9/18/17 - U.S. FDA Approves New Indication for Ipsen's Somatuline Depot (lanreotide) Injection for the Treatment of Carcinoid Syndrome
Ipsen Biopharmaceuticals, Inc., an affiliate of Ipsen, today announced that the U.S. Food and Drug Administration has approved a supplemental indication for Somatuline Depot Injection 120 mg for the treatment of carcinoid syndrome; when used, it reduces the frequency of short-acting somatostatin analog rescue therapy. Alexandre Lebeaut, MD, Exec
9/18/17 - Varian Expands Clinicians' Cancer-fighting Toolkit with Eclipse 15.5
Varian Medical Systems today announced the newest release of its treatment planning system, Eclipse 15.5. Eclipse 15.5 also provides treatment planning support for Varian's HyperArc HDRT, a new type of radiosurgery treatment. This new type of radiosurgery treatment is designed to capitalize on the unique capabilities of Varian's TrueBeam and E
9/16/17 - FDA OKs Prescription-only App to Help Patients with Substance Use Disorders [Syrian Arab News Agency]
Officials with the FDA have granted marketing permission for the first mobile medical application to help treat people with substance use disorders, including alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence. The FDA reviewed data from a multisite, unblinded 12- week clinical tria
9/16/17 - LAURUS LABS' UNIT GETS NOD FROM US, GERMAN REGULATORS
Laurus Labs Limited has obtained the Establishment Inspection Report from the US Food and Drug Administration for its Finished Dosage Formulations& Active Pharmaceutical Ingredients manufacturing plant, Unit 2, located at Achutapuram in Visakhapatnam. The USFDA inspection was completed in May 2017. The units 1 and 3 located at Parawada in Visakhapa
9/16/17 - New treatment for adults with relapsed follicular lymphoma receives FDA approval [Sport360]
The U.S. Food and Drug Administration has granted accelerated approval to copanlisib, marketed as Aliqopa, for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatmen
9/16/17 - ZYDUS CADILA GETS USFDA APPROVAL FOR TWO DRUGS
Zydus Cadila has received approvals from the US Food and Drug Administration for two drugs that will be manufactured at its facility.
9/16/17 - Zydus Cadila gets USFDA nod for two drugs [Algeria Press Service]
Drug firm Zydus Cadila today said it has received approvals from the US health regulator for its Modafinil and Solifenacin Succinate tablets, and the drugs will be manufactured at Ahmedabad facility. The company has received final approval from the United States Food and Drug Administration to market Modafinil tablets USP in the strengths of 100 mg
9/16/17 - ZYDUS GETS TWO PRODUCT APPROVALS FROM USFDA
Cadila Healthcare Limited has obtained final approval. from the US drug regulator US Food and Drug Administration to market Modafinil tablets USP. The tablets, will be marketed in 100 and 200 milligram strengths.
9/15/17 - Agilent Obtains U.S. FDA Approval for GenetiSure Dx Postnatal Assay
Release date- 14092017- SANTA CLARA, Calif.- 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 scientists can now
9/15/17 - FDA approves first biosimilar for the treatment of cancer
Mvasi, a biosimilar to the cancer drug Avastin, is approved for certain colorectal, lung, brain, kidney and cervical cancers?
9/15/17 - FDA Approves New Treatment for Adults With Relapsed Follicular Lymphoma
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "For patients with relapsed follicular lymphoma, the cancer often comes back even after multiple treatments," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Hematolo
Articles(s): 1 - 25 of 213     Next >>     Go To Page:


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