Le Lézard

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

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13 octobre 2017

15:01
SHINGRIX a été homologué au Canada pour la prévention du zona chez les adultes de 50 ans ou plus i. SHINGRIX est un vaccin sous-unitaire non vivant, recombinant avec adjuvant qui est administré par voie intramusculaire en deux doses et qui devrait...

14:59
SHINGRIX has been approved in Canada for the prevention of shingles (herpes zoster) in people aged 50 years or older.i  SHINGRIX is a non-live, recombinant subunit adjuvanted vaccine given intramuscularly in two doses and is expected to be available...

10:00
Royal Philips , a global leader in health technology, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the new eL18-4 transducer with full solution for 'small parts' assessment, which is an...

06:30
Prometic Life Sciences Inc. (Prometic) today announced that the U.S Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for its plasminogen replacement therapy (RyplazimTM) having  granted a priority review...

06:30
Prometic Sciences de la Vie inc. (« Prometic ») a annoncé aujourd'hui que la Food and Drug Administration (FDA) américaine a accepté sa demande de licence de produits...


12 octobre 2017

11:18
Today, the U.S. Food and Drug Administration cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the United States. The Magnetom Terra is the first 7T...

09:00
Galderma, a global leader focused on medical solutions in skin health, announced today it has received U.S. Food and Drug Administration (FDA) approval for the use of a small blunt tip cannula with Restylane® Silk for lip augmentation.2 Restylane®...

08:45
Divoti USA will engrave and process all non-coated stainless steel Medical Alert Jewelry up to the standard of the latest FDA requirements, which stipulates new criteria regarding medical device manufacture and distribution. (Launched: June 2017)....

08:30
NuVasive, Inc. , a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced that it has received expanded 510(k) clearance from the U.S. Food and Drug...

06:45
AcelRx Pharmaceuticals, Inc. (AcelRx), a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for DSUVIAtm...

06:45
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation for its New Drug Application (NDA) for Verzeniotm (abemaciclib), a cyclin-dependent kinase (CDK)4 & 6 inhibitor. The NDA...


11 octobre 2017

23:00
Samsung BioLogics announced today that on October 11,...

09:00
Upsher-Smith Laboratories, LLC. (Upsher-Smith) today announced the launch of Exemestane Tablets, 25 mg. The company recently received U.S. Food and Drug Administration (FDA) approval of its abbreviated new drug application (ANDA) for the product....

08:44
Janssen Biotech, Inc. today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for apalutamide, an investigational, next generation oral androgen receptor (AR) inhibitor for men with...


10 octobre 2017

21:00
Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of gilteritinib for adult patients with FLT3...

09:53
Respicardia, Inc., a private medical technology company, announced today that it received U.S. Food and Drug Administration (FDA) approval of its remed?® System, a transvenous implantable neurostimulation system that stimulates the phrenic nerve, and...

09:00
Today, Ansun BioPharma announced that the Division of Antiviral Products of the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Ansun's first-in-class experimental compound DAS181, for the treatment of lower...

09:00
Boehringer Ingelheim today announced that the supplemental New Drug Application (sNDA) for Gilotrif® (afatinib) has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). The application for Gilotrif is...

08:30
Ultragenyx Pharmaceutical Inc. , a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, Kyowa Hakko Kirin Co., Ltd. (Kyowa Hakko Kirin) and Kyowa Kirin International PLC (Kyowa Kirin International)...


9 octobre 2017

07:00
Flexion Therapeutics, Inc. will hold a conference call today, Monday, October 9, 2017, at 8:00 a.m. ET to discuss the recent U.S. Food and Drug Administration (FDA) approval of ZILRETTAtm (triamcinolone acetonide extended-release injectable...


6 octobre 2017

16:59
The U.S. Food and Drug Administration today approved a new treatment option for patients who have been diagnosed with moderate to severe central sleep apnea. The Remed? System is an implantable device that stimulates a nerve located in the chest that...

08:07
The injury and surgery recovery technology leader, Game Ready®, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its revolutionary orthopedic rehabilitation device, the Med4 Elitetm....


5 octobre 2017

17:39
The U.S. Food and Drug Administration today approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from...

16:01
Hologic, Inc. announced today that it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for its Panther Fusion® Flu A/B/RSV assay running on the new Panther Fusion® system.  The Panther Fusion is available as...

11:57
McGuff Pharmaceuticals, Inc., a wholly owned subsidiary of McGuff Company, Inc. announces the United States Food and Drug Administration's New Drug Approval (NDA) of Ascor® (Ascorbic Acid Injection USP). Ascor® is...

07:00
Cepheid announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to market Xpert® Xpress Strep A. The test provides rapid, accurate, and reliable molecular detection of Streptococcus pyogenes (Group A...

07:00
Neurocrine Biosciences, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved an 80 mg INGREZZA® (valbenazine) capsule strength to be used for the treatment of adults with tardive dyskinesia (TD). INGREZZA, a novel,...


4 octobre 2017

17:16
Solta Medical, a division of Valeant Pharmaceuticals North America LLC, announced today that its Thermage FLXtm System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the face, eyes, and...

16:16
Peerbridge Health Inc., a Health IT company, announced today that its first product, the Peerbridge Cortm System -- a wireless electrocardiogram (ECG) monitor -- has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The...

13:00
FDA issues final Guidance for Industry, transferring regulatory authority to EPA  Following new Guidance issued by the U.S. Food and Drug Administration's Center for Veterinary Medicine (FDA-CVM), regulatory jurisdiction for Oxitec's Friendlytm...

10:14
Intellijoint Surgical®, a medical technology company, is pleased to announce that it has received the approval of the CE Mark (Conformité Européenne) for its intellijoint HIP® System in Europe. A 3D Mini-Optical Navigation System, intellijoint HIP®...

09:54
On September 29, 2017, the U.S. Food and Drug Administration (FDA) proposed an extension of the compliance dates for the final rules mandating changes to food, beverage, and supplement labeling.  The extension would provide large food businesses...

09:00
Applied Spectral Imaging (ASI), a global leader in computer-assisted biomedical imaging, announced today the launch of PathFusiontm and HiPath Protm, innovative Brightfield and FISH imaging & analysis solutions for pathology. ASI will unveil the new...

08:00
Solta Medical, a division of Valeant Pharmaceuticals International, Inc. ("Valeant"), announced today that its Thermage FLXtm System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the...

04:00
CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces it has secured new equity funding. Existing investors, Archangel Investors and the Scottish Investment Bank...


3 octobre 2017

20:08
Mylan N.V. today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan's Abbreviated New Drug Applications (ANDAs) for Glatiramer Acetate Injection 40 mg/mL for 3-times-a-week injection, an AP-rated, substitutable generic...

09:00
DiscGenics, Inc., a clinical stage regenerative medicine company focused on developing regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, is pleased to announce that it has been...

08:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced immediate plans to initiate screening of blood samples with the cobas® Babesia test under an Investigational New Drug Application protocol. The cobas® Babesia test for use with the cobas® 6800/8800...

07:31
Today Allergan plc announced the FDA approval of BOTOX® Cosmetic for its third indication, the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. This approval makes the...

07:00
Carrot Inc. announced today that its Carbon Monoxide Breath Sensor System has been cleared by the U.S. Food and Drug Administration (FDA) for over-the-counter commercial use in smoking cessation programs. The Bluetooth-enabled mobile device, which...


2 octobre 2017

16:05
QIAGEN today announced that its manufacturing and supply chain for consumables and other products for forensic and human identity testing has been certified by Bureau Veritas, a leading inspection agency, as meeting the latest international...

12:39
Mylan N.V. today announced the U.S. launch of Caspofungin Acetate for Injection, one of the first generic versions of Merck's Cancidas®. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug...

08:00
Allergan plc , a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam) for priority review. The sNDA filing...

07:00
Alere Inc. , a global leader in rapid diagnostics, today announced that its Aleretm i Influenza A & B 2 test has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the detection of influenza A and B infection in...

06:56
Lannett Company, Inc. today announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg, the therapeutic...


29 septembre 2017

16:59
Mylan N.V. today announced the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis's Gleevec® Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug...

11:03
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved Fiasp® (insulin aspart injection) 100 Units/mL, a fast-acting mealtime insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes.1...


28 septembre 2017

14:25
The U.S. Food and Drug Administration today approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has...

09:00
Expanding Orthopedics Inc. (EOI), a privately-held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced FDA 510(k) clearance for the FLXfittm15, enhancing the already...

07:00
Impopharma Inc. ("Impopharma") today announced that it has entered into an asset purchase, license, and commercialization agreement with Breckenridge Pharmaceutical, Inc. ("Breckenridge"). Under terms of the agreement, Breckenridge has acquired the...

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