Le Lézard

Communiqués de presse par sujet : Approbation de la FDA (Food and Drug Administration)

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7 mai 2018

07:00
Salix Pharmaceuticals, Ltd. ("Salix"), one of the largest specialty pharmaceutical companies in the world committed to the prevention and treatment of gastrointestinal diseases and a wholly owned subsidiary of Valeant Pharmaceuticals International,...

07:00
US launch date: second half of 2018  In Europe, PLENVU® is available through Norgine  Norgine B.V. today announced that the US Food and Drug Administration (FDA) has approved PLENVU® (NER1006), an osmotic laxative indicated for cleansing of the...

07:00
Kindred Biosciences, Inc. , a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the U.S. Food and Drug Administration's Center for Veterinary Medicine approved Mirataz (mirtazapine transdermal ointment)...


6 mai 2018

20:00
STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its active pharmaceutical ingredient (API) R&D and manufacturing facility located in Changzhou, China has secured Pre-Approval Inspection (PAI) for two APIs from...


4 mai 2018

12:42
The U.S. Food and Drug Administration approved Tafinlar (dabrafenib) and Mekinist (trametinib), administered together, for the treatment of anaplastic thyroid cancer (ATC) that cannot be removed by surgery or has spread to other parts of the body...

08:00
PaxVax, a leading independent specialty vaccine company, announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its vaccine for the prevention of disease caused by the chikungunya virus....


3 mai 2018

14:58
Histogen, Inc., a regenerative medicine company focused on stimulating the body's stem cells to regenerate tissues and restore youthful function, has received approval of its Investigational New Drug (IND) application from the US Food and Drug...

09:00
Abbott  today announced U.S. Food and Drug Administration (FDA) clearance of the Advisortm HD Grid Mapping Catheter, Sensor Enabledtm. Advisor HD Grid employs a new design that allows physicians to see things differently, capturing and analyzing data...

08:00
Forty Seven, Inc., a clinical-stage company focused on developing checkpoint therapies to activate macrophages in the fight against cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted two Fast Track designations to...


2 mai 2018

17:36
Takeda Pharmaceutical Company Limited (Takeda; TSE: 4502) and H. Lundbeck A/S (Lundbeck; LUN.CO, LUN DC, HLUYY) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application for TRINTELLIX® (vortioxetine)....

08:26
Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International , today announced that the U.S. Food and Drug Administration (FDA) has approved the Bausch + Lomb ULTRA® family of contact lenses...

07:30
Paradigm Spine, LLC, a leader in providing motion preservation solutions for the treatment of lumbar spinal stenosis, today announced that the U.S. Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for its coflex®...

07:00
REGENXBIO Inc. , a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced that the U.S. Food and Drug Administration...


1 mai 2018

16:41
Novartis today announced the US Food and Drug Administration (FDA) has approved Kymriah® (tisagenlecleucel) suspension for intravenous infusion for its second indication ? the treatment of adult patients with relapsed or refractory (r/r) large B-cell...

13:28
Actelion Pharmaceuticals Ltd, qui fait partie des Sociétés pharmaceutiques Janssen de Johnson & Johnson, a annoncé...


30 avril 2018

16:29
Novartis announced today that the US Food and Drug Administration (FDA) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutation, as detected...

10:37
Meditech Spine, LLC, announced today it has received additional 510(k) clearance for its CURE Lumbar Plating (LP) System from the US Food and Drug Administration (FDA). The CURE LP iView and Cure LP QMax System clearance compliments Meditech's recent...

09:00
Actelion Pharmaceuticals Ltd, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, today announced the submission of a supplemental New Drug Application...

09:00
Stealth BioTherapeutics (Stealth), a clinical-stage biopharmaceutical company developing therapeutics to treat mitochondrial dysfunction, announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted...

08:00
Body Vision Medical, a medical device company specializing in augmented real-time imaging, artificial intelligence and intra-body navigation, announced today that it has received clearance from the U.S. Food and Drug Administration to market their...


26 avril 2018

11:07
Mobius Imaging, LLC, announced today that it has received 510(k) clearance for its Airo® Mobile CT Imaging System for pediatric applications. The Airo Mobile CT Imaging System previously received 510(k) clearance in 2013 for non-pediatric imaging and...

10:00
Dynamic MUSICA processes fluoroscopic images with the same high-quality/low-dose features, providing greater diagnostic confidence The DR 800 includes a range of features and tools that minimize exam preparation time, procedure time and the wait for...


25 avril 2018

08:30
Theravance Biopharma, Inc. ("Theravance Biopharma") today highlighted that the US Food and Drug Administration (FDA) has approved an expanded indication for Trelegy Ellipta. This expanded approval in the US allows Trelegy Ellipta to be used as a...

08:05
Hologic, Inc. announced today that the United States Food and Drug Administration (FDA) has granted premarket approval (PMA) for the ThinPrep® Integrated Imager, which will make automated imaging of Pap tests more broadly available to laboratories...

07:30
Global pharmaceutical company Mylan N.V. today announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, a generic version of Bayer's Yaz® Tablets. Mylan Pharmaceuticals received final approval from the U.S. Food and...

05:00
The US Food and Drug Administration have accepted an application for a clinical development study on Dronabinol Inhalation using Senzer's unique breath-actuated inhaler, progressing the Company's US partner, INSYS Therapeutics, on its path for...


24 avril 2018

17:19
The PKD Foundation is excited to announce that on April 24 the U.S. Food and Drug Administration (FDA) granted approval of JYNARQUEtm (pronounced jin-AR-kew and also known as tolvaptan) to be the first treatment in the United States for adult...

16:02
Kindred Biosciences, Inc. , a biopharmaceutical company focused on saving and improving the lives of pets, today announced that it has received a response from the Food and Drug Administration (FDA) for the Chemistry, Manufacturing, and Controls...

10:10
Lin BioScience, a drug development company targeting unmet clinical needs in oncology, ophthalmology and metabolic diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LBS-007 for acute...

08:00
Quotient Limited ("Quotient") , an established, commercial-stage diagnostics company, today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts.      (Logo:...

03:00
Quotient Limited ("Quotient") , an established, commercial-stage diagnostics company, today announced the recent FDA approval for U.S. commercialization of seven new blood bank reagents including two market firsts.      (Logo:...


23 avril 2018

20:11
Eli Lilly and Company and Incyte Corporation announced today that the U.S. Food and Drug Administration's (FDA) Arthritis Advisory Committee recommended approval of the 2-mg dose of baricitinib, a once-daily oral medication for the treatment of...

09:00
Viz.ai, Inc., an applied artificial intelligence healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has cleared Viz CTP through the 510(k) pathway. Viz CTP offers image processing software to view and analyze...


20 avril 2018

08:15
Varian today announced it has received FDA 510(k) clearance for its Calypso® Anchored Beacon® transponder. Used with a Varian TrueBeam®, Edge® and Clinac® C-series medical linear accelerators, the Calypso system and Anchored Beacon transponder...

08:14
Veloxis Pharmaceuticals A/S announced today that the U.S. Food & Drug Administration (FDA) has accepted for standard review the Company's supplemental New Drug Application (sNDA) which seeks a new indication for ENVARSUS XR (tacrolimus...


19 avril 2018

05:00
OBI Pharma, Inc., une société pharmaceutique taïwanaise (TPEx : 4174), a annoncé aujourd'hui que la Food and Drug Administration (FDA) des États-Unis a approuvé sa demande de...

05:00
OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for a Phase I/II...


18 avril 2018

19:17
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced it has received approval from the U.S. Food and Drug Administration (FDA) of its Premarket Approval (PMA) supplement for the cobas® EGFR Mutation Test v2 to be used as a companion diagnostic test...

19:06
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved TAGRISSO® (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor...

17:37
Arthrosurface® announced today that The Company received FDA 510(k) Clearance to market the OVOMotiontm Shoulder Arthroplasty System. This stemless total shoulder system provides the surgeon with an approach that results in increased exposure to the...

09:00
Cantel Medical Corp.  announced today that it has received U.S. Food and Drug Administration (FDA) 510 (k) clearance for its ADVANTAGE PLUS® Pass-Thru automated endoscope reprocessor (AER). The ADVANTAGE PLUS® Pass-Thru...

08:30
ANI Pharmaceuticals, Inc. ("ANI") today announced that it has received approval from the U.S. Food and Drug Administration ("FDA") of its Abbreviated New Drug Application ("ANDA") for Morphine Sulfate Oral Solution 10mg/5mL, 20mg/5mL and 100mg/5mL....

03:39
NeuroVive Pharmaceutical AB  , the mitochondrial medicine company, today announced that it has been granted Orphan Drug Designation by the United States FDA Office of Orphan Products Development for its project KL1333 for treatment of inherited...


17 avril 2018

16:51
Rigel Pharmaceuticals, Inc.  today announced that the U.S. Food and Drug Administration (FDA) approved TAVALISSEtm (fostamatinib disodium hexahydrate) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP)...

15:19
First Approved Therapy for XLH in the U.S.; Only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease  Ultragenyx to Host Conference Call Today at 4:30 pm Eastern Time  Ultragenyx Pharmaceutical Inc. , a...

13:28
The U.S. Food and Drug Administration today approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets. XLH causes low levels of...

08:00
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has provided full approval for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate). Praxbind is indicated for...

07:00
King-Devick technologies, inc., a leading provider of evidence- based assessment tools, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market their new K-D Balancetm application, which is to be...


16 avril 2018

17:00
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced the completion of the first surgical case utilizing its Persona® Trabecular Metaltm (TM) Tibia by Dr. Richard Moore, Boise, Idaho on March 20, 2018. The...

06:50
Alkermes plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALKS 5461, a novel, once-daily, oral investigational medicine for the adjunctive treatment of major depressive...

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