Le Lézard

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

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20 novembre 2018

07:30
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam), seeking to expand the label to include the...

07:00
BioLineRx Ltd. , a clinical-stage biopharmaceutical company focused on oncology and immunology, announced today that the U.S. Food and Drug Administration (FDA) has granted the Biological Product Designation for AGI-134, the Company's novel...


19 novembre 2018

10:14
SIG Medical (www.sigmedical.net) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its AdvantageRib Anterior System, K182179. This product is the second rib fracture system that SIG Medical is...

08:07
Aries Pharmaceuticals, Inc. (a Cosmo Pharmaceuticals N.V. Company) announced today that the U.S. Food and Drug Administration (FDA) has approved AEMCOLOtm (rifamycin) 194mg delayed-release tablets, a new minimally absorbed antibiotic that is...

08:06
Indivior PLC (LON: INDV) today announced that PERSERIStm (risperidone) for extended-release injectable suspension is now available in the United States. PERSERIS is approved by the U.S. Food and Drug Administration (FDA) for the treatment of...


16 novembre 2018

16:41
Novartis announced today that the US Food and Drug Administration (FDA) has expanded the label for Promacta® (eltrombopag) to include first-line treatment for adults and pediatric patients two years and older with SAA in combination with standard...

11:46
The U.S. Food and Drug Administration today expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA...


15 novembre 2018

14:58
TSO3 inc. (la « Société » ou « TSO3 »), une société innovatrice du domaine de la technologie de stérilisation des instruments médicaux en milieu hospitalier, annonce aujourd'hui que les résultats de l'étude clinique de la Société et les essais en...

14:56
TSO3 Inc. ("TSO3" or the "Company") , an innovator in sterilization technology for medical devices in healthcare settings, announces today that the results of the Company's clinical in-use and simulated use testing of the terminal sterilization of...

09:00
Abbott today announced the launch of the new DRG Invisible Trial System, which is approved by the U.S. Food and Drug Administration (FDA) and received CE Mark in Europe. People battling complex chronic pain conditions can now use the DRG Invisible...


14 novembre 2018

16:46
The Flexible Vinyl Alliance (FVA) has submitted a petition with the U.S. Food and Drug Administration to update its regulations by removing the clearances for 26 ortho-phthalates that are no longer used in food contact applications. Phthalates are a...

11:00
Terumo Cardiovascular Group, a global leader in cardiovascular surgery technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the CDI® Blood Parameter Monitoring System 550, adding real-time...

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 the U.S. Food and Drug Administration (FDA)...


13 novembre 2018

12:36
STERIBITE, LLC, a medical device company focused on developing unique, disposable surgical instruments, today announced it has received 510(k) clearance from the FDA to market its first product, the patented STERIBITE DISPOSABLE KERRISON RONGUER.  ...

08:30
Cesca Therapeutics Inc. , a market leader in automated cell processing and point-of-care, autologous cell-based therapies, today announced that its device subsidiary, ThermoGenesis® Corp., has filed a Device Master File (MAF) with the U.S. Food and...

08:00
Bio2 Technologies, Inc., a privately held orthopedics company, announced today that it received U.S. Food and Drug Administration ("FDA") approval to begin enrollment in an IDE clinical study to evaluate Vitrium as a cervical interbody fusion...

08:00
Modis Therapeutics announced today that the European Medicines Agency (EMA) has granted PRIME (PRIority MEdicines) designation to MT1621, Modis' investigational treatment for patients with thymidine kinase 2 deficiency (TK2d). The PRIME designation...


12 novembre 2018

21:00
Esco Medical, the IVF medical technology business unit of the Esco Group, today announced that it has received the China Food and Drug Administration (CFDA) approval on the MIRI® Time-Lapse and MIRI® Benchtop Multi-room embryo incubators. The MIRI®...

10:46
PolyPid Ltd., a clinical-stage biopharmaceutical company focused on developing and commercializing novel, locally administered therapies for post-surgical complications, announced today that the United States Food and Drug Administration (FDA) has...

06:00
RoosterBio Inc, a leading supplier of human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks and hMSC-specific bioprocess systems, announces today it has submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its...


9 novembre 2018

17:41
The American College of Chest Physicians (CHEST) is disappointed with the FDA's decision to approve over-the-counter epinephrine (Primatene Mist HFA) for the treatment of asthma. CHEST is a nonprofit organization dedicated to advancing best patient...

15:13
Theravance Biopharma, Inc. ("Theravance Biopharma") and Mylan N.V. ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the  New Drug Application (NDA) for YUPELRITM (revefenacin) inhalation solution for the...

11:01
Today, the U.S. Food and Drug Administration announced that an emergency use authorization (EUA) has been issued for a rapid, single-use test for the detection of Ebola virus (Zaire ebolavirus). This is the second Ebola rapid antigen fingerstick test...


8 novembre 2018

16:05
NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced it has received 510(k) clearance from the U.S. Food and Drug...


7 novembre 2018

07:57
MaxQ AI, a clinical diagnostics intelligence platform company, today announced that its revolutionary Accipio Ix intracranial hemorrhage (ICH) detection software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The...

07:00
Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of BRYHALItm (halobetsasol propionate) Lotion,...

05:00
PixCell Medical announced today that The HemoScreentm Hematology Analyzer received FDA 510(k) clearance, enabling commercialization in the USA. The HemoScreentm is a miniature portable...


6 novembre 2018

08:30
Cumberland Pharmaceuticals Inc.  announced today that it has entered into a definitive agreement to acquire VIBATIV® from Theravance Biopharma. Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused on the delivery of...

08:30
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that the VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration for...

08:00
The U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis, whose...

07:54
Partner Therapeutics, Inc. (PTx), a commercial biotechnology company, announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Leukine® (sargramostim), a yeast-derived recombinant human granulocyte-macrophage...

00:59
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® (dupilumab) in adolescent patients 12 to...


5 novembre 2018

08:30
Galderma Laboratories, L.P., a global leader focused on medical solutions in skin health, announced today that it has received U.S. Food and Drug Administration (FDA) approval for the use of Restylane Lyft®, a hyaluronic acid (HA) dermal filler, with...

06:30
Shoulder Innovations announced today that they have received FDA clearance for their InSet Humeral Short Stem System.  This is a key addition to their expanding shoulder portfolio and another milestone for their vision to offer a complete leading...


2 novembre 2018

13:57
The crisis of opioid addiction is an issue of great concern for our nation. Addressing it is a public health priority for the FDA. The agency is taking new steps to more actively confront this crisis, while also paying careful attention to the needs...

13:56
AcelRx Pharmaceuticals, Inc. (AcelRx) , a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in a medically supervised setting, announced today the approval of DSUVIAtm by the U.S. Food...

08:00
Aquestive Therapeutics, Inc. , a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved SYMPAZANtm (clobazam) oral film for the adjunctive treatment of seizures associated with Lennox-Gastaut...


1 novembre 2018

09:00
TORONTO, Nov. 1, 2018 /PRNewswire-PRWeb/ -- Focal Healthcare, an innovator of image-guided prostate cancer technology, announced it has received both FDA 510(k) clearance and Health Canada approval for its Fusion Bxtm 2.0 prostate biopsy solution....

05:30
OsteoRemedies®, LLC, a company focused on providing simple solutions to complex disorders, is pleased to announce the launch of the REMEDY SPECTRUMtm? GV Hip Spacer System and SPECTRUMtm? GV Bone Cement.  Building on its portfolio consisting of the...

01:30
Senhwa Biosciences Inc. (TPEx: 6492) announced today that FDA has approved its IND application for basal cell carcinoma (BCC). To accelerate the development of this new drug, Senhwa followed the latest draft guidance released by FDA for clinical...


31 octobre 2018

18:54
In another first, the U.S. Food and Drug Administration (FDA) granted 23andMe de novo authorization to offer reports on pharmacogenetics, indicating how customers' genetics may influence the way they metabolize certain medications....

16:01
Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New...


30 octobre 2018

17:12
The United States Food and Drug Administration (FDA) has accepted a Biologics License Application for Sanofi Pasteur's dengue vaccine. The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only...

09:00
ANGUS Chemical Company ("ANGUS" or "Company"), a leading global manufacturer and marketer of specialty chemicals, announced today that the U.S. Food and Drug Administration (FDA) has issued an expanded Food Contact Substance Notification (FCN) for...

08:45
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved INVOKANA® (canagliflozin) to reduce the risk of major adverse cardiovascular (CV) events, including heart attack,...


29 octobre 2018

08:00
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved its supplemental new drug application (sNDA) on October 26, 2018, to revise labeling for Xyrem® (sodium oxybate) oral solution, CIII, to include an...


27 octobre 2018

08:00
The Annual Meeting of the American Academy of Ophthalmology (AAO) marks ZEISS' U.S. launch of Total Keratometry (TK®) for IOLMaster® 700, offering cataract surgeons the opportunity to replace assumptions about the posterior corneal surface with...


25 octobre 2018

13:00
Alcami Corporation, a leading provider of fully-integrated custom end-to-end solutions for the pharmaceutical and biotechnology industries, announced today its collaboration with Medicines Development for Global Health (MDGH), a not-for-profit...

10:00
Royal Philips , a global leader in health technology, today announced its 'ultimate ultrasound solution for breast assessment'. Available with the Philips EPIQ and Affiniti ultrasound systems, and the combination of the eL18-4 transducer and...

09:00
Abbott announced today that the U.S. Food and Drug Administration (FDA) has cleared its next-generation Influenza A & B 2 and Strep A 2 molecular assays for point-of-care testing1,2. These new assays enable the fastest-ever3 time to molecular...

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