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 The leading web portal for pharmacy resources, news, education and careers September 19, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - September 19, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 250     Next >>     Go To Page:

8/19/17 - AstraZeneca`s Lynparza gets additional US approval for ovarian cancer [Tehran Times (Iran)]
AstraZeneca and MSD have announced that the US Food and Drug Administration has granted approval for the PARP inhibitor, Lynparza. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca, said: Physicians have almost three years of clinical experience with Lynparza on the market and we are now pleas
8/19/17 - Pfizer wins approval for blood cancer drug Besponsa [Sudan Tribune]
Pfizer today won FDA approval for a new targeted drug for the treatment of relapsed or refractory acute lymphoblastic leukemia. The FDA said nearly 6,000 people in the U.S. will be diagnosed with ALL this year and about 1,440 will die from the disease. A Pfizer spokesperson said in an email, that based on the typical duration of treatment, the tota
8/18/17 - AstraZeneca and Merck & Co., Inc. - LYNPARZA Receives Additional and Broad Approval in the U.S. for Ovarian Cancer
Release date- 17082017- KENILWORTH, N.J.- AstraZeneca and Merck& Co., Inc., known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has granted approval for the PARP inhibitor, LYNPARZA. Sean Bohen, executive vice president, global medicines development and chief medical officer of AstraZeneca,
8/18/17 - AstraZeneca and Merck & Co., Inc. - LYNPARZA receives additional FDA approval in the US for ovarian cancer
Release date- 17082017- AstraZeneca and Merck& Co., Inc., today announced that the US Food and Drug Administration has granted approval for the PARP inhibitor, LYNPARZA, as follows. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca said:' Physicians have almost three years of clinical experien
8/18/17 - FDA Approves New Treatment for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "For adult patients with B-cell ALL whose cancer has not responded to initial treatment or has returned after treatment, life expectancy is typically low," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence
8/18/17 - FDA grants approval of Besponsa for acute lymphoblastic leukaemia
The FDA has approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia...
8/18/17 - Globus Medical Announces FDA 510(k) Clearance for Excelsius GPS [Sport360]
-Globus Medical, Inc., a leading musculoskeletal solutions company, today announced that the Excelsius GPS, a revolutionary robotic guidance and navigation system, has been 510 cleared by the U.S. Food and Drug Administration. Excelsius GPS seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT,...
8/18/17 - Immunalysis Receives FDA Clearance for SEFRIA Fentanyl Urine Drug Screening Test
By a News Reporter-Staff News Editor at Drug Week Immunalysis Corporation, a division of Alere Inc., announced that its SEFRIA? Fentanyl Urine Enzyme Immunoassay has been granted 510 clearance by the U.S. Food and Drug Administration for the qualitative detection of fentanyl in urine. "The availability of an FDA- cleared fentanyl immunoassay e
8/18/17 - LYNPARZA Gets Additional And Broad Approval In U.S. For Ovarian Cancer
LONDON- AstraZeneca and Merck& Co., Inc., announced that the US Food and Drug Administration has granted approval for the PARP inhibitor, LYNPARZA or olaparib, as follows:. New use of LYNPARZA tablets as a maintenance treatment of adult patients with recurrent, epithelial ovarian, fallopian tube or primary peritoneal cancer who are in a complete or
8/18/17 - New Immunoassay for Detection of Buprenorphine and Three Major Metabolites
By a News Reporter-Staff News Editor at Drug Week AACC A new immunoassay for the specific detection of buprenorphine and its three major metabolites buprenorphine-b-D-glucuronide, norbuprenorphine, and norbuprenorphine-b-D-glucuronide has received 510 clearance from the U.S. Food and Drug Administration, registration in Canada, Australia, a
8/18/17 - Pfizer Gets FDA Approval For Rare Blood Cancer Drug Besponsa
NEW YORK CITY- Pfizer Inc. said that the U.S. Food and Drug Administration has approved Besponsa for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia or ALL. BESPONSA was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs. The U.S. labeling for BESPONS
8/18/17 - Pfizer Receives U.S. FDA Approval F=for Besponsa (Inotuzumab Ozogamicin)
Pfizer, a pharmaceutical company, issued the following news release:. Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved BESPONSA for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. 1 BESPONSA was reviewed and approved under the FDA's Breakthrough Therapy designatio
8/18/17 - PFIZER RECEIVES U.S. FDA APPROVAL FOR BESPONSA
Release date- 17082017- Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved BESPONSA for the treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia. 1 BESPONSA was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs.
8/18/17 - VNS Therapy Receives CE Mark for Expanded MRI Labeling
By a News Reporter-Staff News Editor at Drug Week LivaNova PLC, a market-leading medical technology company, announced its latest VNS Therapy Systems received CE Mark for expanded MRI labeling. "The CE Mark comes one month after we received U.S. FDA approval for similar expanded MRI labeling," said Damien McDonald, LivaNova's Chief Executive
8/18/17 - Zydus Cadila gets USFDA nod for hypertension drug [Arab Times (Kuwait)]
The company has received final approval from the US Food and Drug Administration to market the drug in the strengths of 40 mg/12. 5 mg, 80 mg/25 mg, Zydus Cadila said in a BSE filing today. Quoting IMS June 2017 data, the company said the total sales of Telmisartan and Hydrochlorothiazide tablets is estimated at $66.5 million. Shares of the company
8/17/17 - FDA Approves Bunge's Petition to Claim Soybean Oil as Heart Healthy
By a News Reporter-Staff News Editor at Politics& Government Week Bunge North America, the North American arm of Bunge Limited, is pleased to announce that the U.S. Food and Drug Administration approved its petition for a qualified health claim linking consumption of soybean oil to reduced risk of coronary heart disease. Bunge independently filed
8/17/17 - FDA OKs Pfizer drug for rare, fast-killing type of leukemia
The Food and Drug Administration has approved a new medicine for use against a rare, rapidly progressing blood cancer after other treatments have failed. Richard Pazdur, the FDA's director for cancer drugs, said in a statement. The powerful injected drug, known chemically as inotuzumab ozogamicin, comes with the FDA's most-stringent warning beca
8/17/17 - Globus Medical Announces FDA 510(k) Clearance for Excelsius GPS?
Globus Medical, Inc., a leading musculoskeletal solutions company, today announced that the Excelsius GPS?, a revolutionary robotic guidance and navigation system, has been 510 cleared by the U.S. Food and Drug Administration. Excelsius GPS? seamlessly integrates Globus Medical implants and instruments and is compatible with pre-operative CT,
8/17/17 - HEALTH FDA approves new ALS drug
Radicava, an infusion therapy developed in Japan, is now available in the United States and it has proved to be very effective for patients. It's full of hope, " Nancy Frates said. The answer to that is we don't know because we don't have the data, " Nancy Frates said.
8/17/17 - LYNPARZA Receives Additional and Broad Approval in the U.S. for Ovarian Cancer
AstraZeneca and Merck& Co., Inc., known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has granted approval for the PARP inhibitor, LYNPARZA, as follows:. Eric Pujade-Lauraine, head of the women cancers and clinical research department at Hpitaux Universitaires Paris Centre, site Htel-Die
8/17/17 - LYNPARZA (olaparib) Receives Additional FDA Approval in the US for Ovarian Cancer
AstraZeneca and Merck& Co., Inc., today announced that the US Food and Drug Administration has granted approval for the PARP inhibitor, LYNPARZA , as follows:. Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, AstraZeneca said: Physicians have almost three years of clinical experience with LYNPARZA o
8/17/17 - Perrigo Announces FDA Final Approval for its AB Rated Generic Version of Mycolog II Cream
Release date- 16082017- 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 Mycolog II Cream. Perrigo Company plc, a leading global healthcare company, delivers value to its customers and consumers by providing Quality Aff
8/17/17 - Pfizer Receives U.S. FDA Approval for BESPONSA (inotuzumab ozogamicin)
Pfizer Inc. today announced that the U.S. Food and Drug Administration has approved BESPONSA for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. 1 BESPONSA was reviewed and approved under the FDA s Breakthrough Therapy designation and Priority Review programs. The approval of BESPONSA is a
8/17/17 - Prollenium Medical Technologies Inc. announces U.S. FDA approval for its cross-linked hyaluronic acid dermal filler
-Prollenium Medical Technologies Inc., a leading medical device manufacturer, announced today its United States Food and Drug Administration approval for its cross-linked hyaluronic acid dermal filler. Founded in 2002, Prollenium Medical Technologies Inc. has developed a pipeline of innovative products for tissue reconstruction by focusing its...
8/17/17 - ZYDUS GETS USFDA NOD FOR BP DRUG
Cadila Healthcare Limited announced that its group company Zydus Cadila has obtained final approval from the US health regulator to market blood pressure drug, Tiadylt ER. The approval from US Food and Drug Administration for diltiazem hydrochloride extended release capsules is for strengths of 120 milligram, 180 mg, 240 mg, 300 mg and 420 mg.
Articles(s): 1 - 25 of 250     Next >>     Go To Page:


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