New and Generic Drug Approvals

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New and Generic Drug Approvals

fda.gov

Drug Approval Listing

View full resource at fda.gov

Tags: Drug, Pharma, Biotech, FDA, News

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Most Recently Shared on September 15, 2011 at 12:10 pm By:

FiercePharma FiercePharma

Whole raft of generics firms get OK for copycat versions of UCB seizure drug Keppra XR http://t.co/iRRb7KrL

1 year ago...

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Report: FDA strengthens monitoring of post-approval drug safety

fda.gov — “A strengthened and modernized postmarket drug safety program has resulted in a substantial improvement in the U.S. Food and Drug Administration’s oversight of drugs once they reach the American public, according to a new report released today by the agency’s Center for Drug Evaluation and Research (CDER). The report, “Advances in FDA’s Safety Program for Marketed Drugs,” describes new scientific tools and enhanced capabilities that give the same priority to postmarket drug safety monitoring as tView full resource at fda.gov

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Most Recently Shared on April 21, 2012 at 8:42 pm By:

HealthTrendster HealthTrendster Health Executive

Report: FDA strengthens monitoring of post-approval drug safety: A strengthened and… http://t.co/Nlax6RLR

4 days ago...

EU agency endorses Bristol, Astra diabetes drug | Reuters

reuters.com — “LONDON (Reuters) - European regulators on Friday backed approval of a new diabetes drug from AstraZeneca and Bristol-Myers Squibb that was rejected last year in the United States.Dapagliflozin belongsView full resource at reuters.com

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Most Recently Shared on April 20, 2012 at 2:07 pm By:

HealthPassion HealthPassion Health News

EU agency endorses Bristol, Astra diabetes drug: LONDON (Reuters) - European regulators on Friday backed approva... http://t.co/EeIYYqhz

5 days ago...

EU agency endorses Bristol, Astra diabetes drug | Reuters

in.reuters.com — “LONDON (Reuters) - European regulators on Friday backed approval of a new diabetes drug from AstraZeneca and Bristol-Myers Squibb that was rejected last year in the United States.Dapagliflozin belongsView full resource at in.reuters.com

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Most Recently Shared on April 20, 2012 at 2:01 pm By:

Reuters_Health Reuters Health Health News

EU agency endorses Bristol, Astra diabetes drug http://t.co/nNNLGw4j

5 days ago...

Study finds high rates of off-label prescribing | Reuters

in.reuters.com — “NEW YORK (Reuters Health) - More than 10 percent of prescriptions in one Canadian province were for drugs not approved to treat the patient's condition, a new study finds. And many times, there was littleView full resource at in.reuters.com

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Most Recently Shared on April 19, 2012 at 8:37 pm By:

Reuters_Health Reuters Health Health News

Study finds high rates of off-label prescribing http://t.co/BkFNiIyM

6 days ago...

Medgenics seeks IND approval to initiate EPODURE Biopump Phase IIb anemia study in ESRD patients

news-medical.net — “Medgenics, Inc., the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed an Investigational New Drug application with the U.S. Food and Drug Administration to initiate a Phase IIb multi-center, 100-patient clinical trial.View full resource at news-medical.net

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Most Recently Shared on April 18, 2012 at 4:01 pm By:

Diabetes_Med News-Medical.Net Health News

Diabetes News: Medgenics seeks IND approval to initiate EPODURE Biopump Phase IIb anemia study in ESRD patients:... http://t.co/ol32Ok8K

7 days ago...

Abbott wins EU approval for new use of Humira drug | Reuters

reuters.com — “(Reuters) - Humira, the best-selling arthritis drug that forms the cornerstone of Abbott Laboratories' pharmaceutical business, has been approved in Europe for ulcerative colitis, the U.S. drugmaker saidView full resource at reuters.com

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Most Recently Shared on April 11, 2012 at 6:12 am By:

Drugs_Devices Drugs and Devices OW OW Health

Abbott wins EU approval for new use of Humira drug - Reuters: Abbott wins EU approval for new use of Humir... http://t.co/LSZvbDEi #drug

2 weeks ago...

Can a Dirt-Cheap Diabetes Drug Fight Cancer? - Health News - Health.com

news.health.com — “By Anne Harding FRIDAY, April 6, 2012 (Health.com) — Each year billions of dollars are spent in the search to find new cancer drugs. Very few of these would-be treatments end up being approved by the government and entering widespread use, which makes it all the more intriguing that one of the ...View full resource at news.health.com

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Most Recently Shared on April 6, 2012 at 10:40 pm By:

diabetorati Walter Adamson Patient Expert

Can a Dirt-Cheap Diabetes Drug Fight Cancer?: FRIDAY, April 6, 2012 (http://t.co/TuSWYJq4) — Each year billions o... http://t.co/eMk00plc

3 weeks ago...

New diet drug Qnexa awaits FDA approval amid safety questions – USATODAY.com

usatoday.com — “Some experts say it could potentially help dieters lose about 10% of their weight, but with its former FDA rejection, how safe is it?View full resource at usatoday.com

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Most Recently Shared on April 4, 2012 at 10:45 pm By:

USATODAYhealth Maureen Linke Health News

Diet drug Qnexa awaits FDA approval amid safety questions http://t.co/YjlUT7Bn

3 weeks ago...

Teva Jumps as New Drugs Bolster Outlook: Israel Overnight - Bloomberg

bloomberg.com — “Teva Pharmaceutical Industries Ltd. extended its best start to a year since 2010 as exclusive rights to sell two medications boosted prospects U.S. sales for the world’s largest maker of generic drugs will recover in 2012.View full resource at bloomberg.com

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Most Recently Shared on April 3, 2012 at 12:17 pm By:

FiercePharma FiercePharma Health Site

Teva benefits from exclusives on generic Avapro, Avalide. Provigil and Seroquel copies don't hurt, either http://t.co/v1mrcc1s #pharma

3 weeks ago...

Consumer Reports Warns of Lax Testing for Medical Devices - ABC News

abcnews.go.com — “Consumer Reports advises patients to do their homework before having medical devices implanted in their bodies.  Companies that sell defibrillators, stents or other such products can get approval from the Food and Drug Administration without their undergoing rigorous testing, Consumer Reports warned in a new report. The FDA collects information on medical device malfunctions that lead to death. Data highlighted by Consumer Reports show 686 deaths from 2009 to last year connected to automateView full resource at abcnews.go.com

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Most Recently Shared on March 29, 2012 at 7:39 pm By:

HITpol HealthIT Policy Health IT and Health News

Consumer Reports Warns of Lax Testing for Medical Devices: Consumer Reports advises patients to do their homewor... http://t.co/z5sM68RZ

4 weeks ago...

Amgen Loses Monopoly on Drug for Dialysis Patients - NYTimes.com

nytimes.com — “The Food and Drug Administration approved a new anemia drug called Omontys for dialysis patients, which will end Amgen’s 24-year monopoly led by its Epogen drug.View full resource at nytimes.com

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Most Recently Shared on March 28, 2012 at 7:47 pm By:

richmeyer Rich Meyer Health Executive

Amgen Loses Monopoly on Drug for Dialysis Patients - http://t.co/O6kMuGDy #pharma

4 weeks ago...

Amgen Loses Monopoly on Drug for Dialysis Patients - NYTimes.com

nytimes.com — “The Food and Drug Administration approved a new anemia drug called Omontys for dialysis patients, which will end Amgen’s 24-year monopoly led by its Epogen drug.View full resource at nytimes.com

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Most Recently Shared on March 28, 2012 at 6:19 pm By:

Amgen Loses Monopoly on Drug for Dialysis Patients - NYTimes.com

nytimes.com — “The Food and Drug Administration approved a new anemia drug called Omontys for dialysis patients, which will end Amgen’s 24-year monopoly led by its Epogen drug.View full resource at nytimes.com

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Most Recently Shared on March 28, 2012 at 10:51 am By:

Amgen Loses Monopoly on Drug for Dialysis Patients - NYTimes.com

nytimes.com — “The Food and Drug Administration approved a new anemia drug called Omontys for dialysis patients, which will end Amgen’s 24-year monopoly led by its Epogen drug.View full resource at nytimes.com

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Most Recently Shared on March 28, 2012 at 1:16 am By:

Amgen Loses Monopoly on Drug for Dialysis Patients - NYTimes.com

nytimes.com — “The Food and Drug Administration approved a new anemia drug called Omontys for dialysis patients, which will end Amgen’s 24-year monopoly led by its Epogen drug.View full resource at nytimes.com

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Most Recently Shared on March 27, 2012 at 7:30 pm By:

HealthTrendster HealthTrendster Health Executive

F.D.A. Approves New Anemia Drug - A new anemia drug provides a less expensive alternative for dialysis patients and ... http://t.co/9YfRzcyE

4 weeks ago...

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