Xiaflex New Drug Application
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Xiaflex New Drug Application
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Tags: Disease and Condition, Drug, News, disease, Dupuytren Contracture, Hand Disorder
Most Recently Shared on February 8, 2010 at 2:19 pm By:
If you know what #Peyronie's disease is you would be glad to know there may be treatment. http://bit.ly/9vo8Ve
FDA Issues Complete Response Letter to NDA for Adasuve - MPR
empr.com — “Alexza Pharmaceuticals announced that it has received a complete response letter from the FDA regarding its New Drug Application (NDA) for Adasuve (Staccato loxapine) inhalation powder, 5mg and 10mg, for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.” View full resource at empr.com
Most Recently Shared on May 7, 2012 at 3:35 pm By:
FDA Issues Complete Response Letter to NDA for #Adasuve #Alexza #loxapine #inhalation #agitation http://t.co/UloQRAV8
Zogenix Submits New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for Zohydro for Treatment of Chronic Pain
drugs.com — “Zohydro (hydrocodone) is a new drug formulation in development for the treatment of chronic pain. Zohydro information includes news, clinical trial results and side effects.” View full resource at drugs.com
Most Recently Shared on May 3, 2012 at 2:05 am By:
Zogenix Submits NDA to FDA for Zohydro (hydrocodone extended-release capsules) for Chronic Pain - http://t.co/0mRPUjz4
FDA Issues Complete Response Letter to NDA for Alogliptin/Pioglitazone - MPR
empr.com — “Takeda announced that it received a complete response letter from the FDA regarding its New Drug Applications (NDAs) for alogliptin and fixed-dose combination alogliptin and pioglitazone for the treatment of type 2 diabetes.” View full resource at empr.com
Most Recently Shared on April 26, 2012 at 5:01 pm By:
FDA Issues Complete Response Letter to NDA for Alogliptin/Pioglitazone #diabetes #takeda http://t.co/KNCMpJxG
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
Most Recently Shared on April 18, 2012 at 4:01 pm By:
Diabetes News: Medgenics seeks IND approval to initiate EPODURE Biopump Phase IIb anemia study in ESRD patients:... http://t.co/ol32Ok8K
FDA Advisory Committee to review Repligen's SecreFlo NDA on May 31
news-medical.net — “Repligen Corporation today announced that the U.S. Food and Drug Administration's Gastrointestinal Drugs Advisory Committee will meet on May 31, 2012 to discuss the Company's New Drug Application (NDA) for SecreFlo for the improved detection of pancreatic duct abnormalities in combination with magnetic resonance imaging (MRI) in patients with pancreatitis.” View full resource at news-medical.net
Most Recently Shared on March 26, 2012 at 4:52 am By:
FDA Advisory Committee to review Repligen's SecreFlo NDA on May 31: Repligen Corporation today announced that th... http://t.co/ohY0Iubt
POZEN Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of PA32540 - Drugs.com MedNews
drugs.com — “New Drug Application Submission Anticipated in Q3 2012 Detailed Results to be Submitted for Journal Publication and Presentation at a Future Scientific Meeting” View full resource at drugs.com
Most Recently Shared on March 22, 2012 at 1:07 pm By:
Drugs and Devices OW OW Health
POZEN Announces Positive Top-Line Results from Two Pivotal Phase 3 Studies of PA32540: New Drug Applicatio... http://t.co/a45T1YSl #drug
Abbott files suit against Watson over generic NIASPAN
news-medical.net — “Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. – Florida, filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval to market Niacin Extended-release Tablets, 500 mg and 1000 mg. Watson's ANDA products are generic versions of Abbott Laboratories' NIASPAN.” View full resource at news-medical.net
Most Recently Shared on March 19, 2012 at 2:01 pm By:
Abbott files suit against Watson over generic NIASPAN: Watson Pharmaceuticals, Inc. today confirmed that its sub... http://t.co/pk3MiGAR
PaxVax announces FDA acceptance of IND for PXVX-0200 cholera vaccine
news-medical.net — “PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for its single-dose oral cholera vaccine, clearing the way to begin clinical trials. The company intends to begin Phase 3 trials later this year.” View full resource at news-medical.net
Most Recently Shared on March 19, 2012 at 1:12 pm By:
Bird Flu News: PaxVax announces FDA acceptance of IND for PXVX-0200 cholera vaccine: PaxVax Corporation, develop... http://t.co/vN7utz5a
FDA Accepts PaxVax’s IND for Single-Dose Oral Cholera Vaccine - Yahoo! Finance
finance.yahoo.com — “From Yahoo! Finance: PaxVax Corporation, developer of innovative and socially responsible oral vaccines against infectious diseases, announced that the U.S. Food and Drug Administration has accepted its investigational new drug application for its single-dose oral cholera vaccine, clearing the way to begin clinical trials.” View full resource at finance.yahoo.com
Most Recently Shared on March 19, 2012 at 1:03 pm By:
FDA Accepts PaxVax’s IND for Single-Dose Oral Cholera Vaccine: PaxVax Corporation, developer of innovative and s... http://t.co/S88mL9v2
Biodel to Provide Update on Stabilized Glucagon Program at ROTH Conference Today -- DANBURY, Conn., March 14, 2012 /PRNewswire/ --
prnewswire.com — “Biodel to Provide Update on Stabilized Glucagon Program at ROTH Conference Today. New Drug Application for Stabilized Liquid Glucagon submission projected in late 2013 or early 2014.” View full resource at prnewswire.com
Most Recently Shared on March 14, 2012 at 8:37 pm By:
Scott Strumello Patient Expert
Biodel to Provide Update on Stabilized Glucagon Program at ROTH Conference Today (March 14, 2012) http://t.co/EXjgcqUM via @PRNewswire
Nanotube technology leading to new era of fast, lower-cost medical diagnostics
sciencedaily.com — “Researchers have tapped into the extraordinary power of carbon "nanotubes" to increase the speed of biological sensors, a technology that might one day allow a doctor to routinely perform lab tests in minutes, speeding diagnosis and treatment while reducing costs. The new findings have almost tripled the speed of prototype nano-biosensors, and should find applications not only in medicine but in toxicology, environmental monitoring, new drug development and other fields.” View full resource at sciencedaily.com
Most Recently Shared on March 13, 2012 at 12:14 pm By:
Nanotube #technology leading to new era of fast, lower-cost #medical #diagnostics: #path #lab #pharm http://t.co/fK66ggaM via @AddThis
Nanotube technology leading to new era of fast, lower-cost medical diagnostics
sciencedaily.com — “Researchers have tapped into the extraordinary power of carbon "nanotubes" to increase the speed of biological sensors, a technology that might one day allow a doctor to routinely perform lab tests in minutes, speeding diagnosis and treatment while reducing costs. The new findings have almost tripled the speed of prototype nano-biosensors, and should find applications not only in medicine but in toxicology, environmental monitoring, new drug development and other fields.” View full resource at sciencedaily.com
Most Recently Shared on March 12, 2012 at 9:38 pm By:
Nanotube technology leading to new era of fast, lower-cost medical diagnostics: Researchers have tapped into the... http://t.co/giAa7YcQ
Nanotube technology leading to new era of fast, lower-cost medical diagnostics
eurekalert.org — “Researchers have tapped into the extraordinary power of carbon "nanotubes" to increase the speed of biological sensors, a technology that might one day allow a doctor to routinely perform lab tests in minutes, speeding diagnosis and treatment while reducing costs. The new findings have almost tripled the speed of prototype nano-biosensors, and should find applications not only in medicine but in toxicology, environmental monitoring, new drug development and other fields.” View full resource at eurekalert.org
Most Recently Shared on March 9, 2012 at 9:26 pm By:
Nanotube technology leading to new era of fast, lower-cost medical diagnostics: ( Oregon State University ) Rese... http://t.co/DcY9Nr1G
NDA Submitted for Vibex for Keratoconus and Corneal Ectasia - MPR
empr.com — “Avedro announced that it has submitted a New Drug Application (NDA) to the FDA for VibeX (riboflavin ophthalmic solution) /KXL System for the treatment of keratoconus and corneal ectasia following refractive surgery.” View full resource at empr.com
Most Recently Shared on March 8, 2012 at 10:01 pm By:
NDA Submitted for Vibex for Keratoconus and Corneal Ectasia http://t.co/0Y9WFwQN #ocular #ophthalmic
F.D.A. Rejects Merck’s Application for Combination Drug - NYTimes.com
nytimes.com — “The proposed new drug would combine Merck’s drug Zetia, which lowers “bad” cholesterol, with the generic version of Lipitor, the statin made by Pfizer.” View full resource at nytimes.com
Most Recently Shared on March 7, 2012 at 5:57 pm By:
David Rubin Internist, Physician, and Doctor
Kind of sad, and I'm glad the FDA rejected it. Effectively saying they think Lipitor is better than Zocor (their drug!) http://t.co/Vl6DuWcv
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