Le Lézard

News by subject: FDA

28 november 2018

14:46
The U.S. Food and Drug Administration today approved Xospata (gilteritinib) tablets for the treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test. The FDA...

13:47
The U.S. Food and Drug Administration today approved Truxima (rituximab-abbs) as the first biosimilar to Rituxan (rituximab) for the treatment of adult patients with CD20-positive, B-cell non-Hodgkin's lymphoma (NHL) to be used as a single agent or...

08:00
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS® Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (VITROS® HIV Combo test) received approval from the U.S. Food and Drug Administration for...


27 november 2018

10:00
HighTide Therapeutics Inc., a clinical-stage biopharmaceutical company, announced that the U.S. FDA has granted Fast Track Designation to its investigational new drug, HTD1801, for the treatment of patients with nonalcoholic steatohepatitis (NASH).  ...

08:00
United Orthopedic Corporation, a leading international designer, manufacturer, and distributor of innovative orthopedic implants and instruments, today announced that the U.S. Food and Drug Administration has cleared its vitamin E highly cross-linked...

07:00
Mesa Biotech Inc., is a privately held, molecular diagnostic company that has developed an affordable and easy to operate PCR (polymerase chain reaction) testing platform designed specifically for point-of-care (POC) infectious disease diagnosis....


26 november 2018

20:43
The U.S. Food and Drug Administration (FDA) today approved Vitrakvi® (larotrectinib), the first ever oral TRK inhibitor, for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene...

18:41
The U.S. Food and Drug Administration today granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker). This is the...

09:01
Perrigo Company plc today announced it has received tentative approval from the U.S. Food and Drug Administration for the first to file generic version of Ultravate® Lotion (halobetasol propionate) 0.05%.  Perrigo previously announced a patent...

09:00
Ultimaker, the global leader in desktop 3D printing, today announced that the Ultimaker S5 has been certified by Materialise as a 3D printing solution to create orthopedic, maxillofacial and cardiovascular models for clinical use when used in...

08:30
Ampio Pharmaceuticals, Inc. today updates the regulatory and peer-review publication status of Ampion. Regulatory update:Statisticians representing Ampio and the FDA met recently to discuss the clinical pathway of...

07:00
Shire Pharma Canada ULC (Shire Canada), the leading global biotechnology company focused on rare diseases, is pleased to announce that on November 21, 2018 Health Canada authorized the extended indication for ADYNOVATE® [Antihemophilic Factor...


22 november 2018

13:32
Medtronic of Canada Ltd., a subsidiary of Medtronic plc announced today that it has received a licence from Health Canada for the Visualasetm MRI-Guided Laser Ablation System. The Visualase system provides advanced MRI-guided laser ablation...


21 november 2018

14:14
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to VENCLEXTA® (venetoclax tablets) in combination with azacitidine, or decitabine, or...

12:51
The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are...

10:00
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) announced that the U.S. Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) and granted Priority Review for quizartinib for the treatment of adult patients with...

05:00
Sciton, Inc. announced today that the FDA has advised the company that it appears that Sciton has satisfactorily addressed all items raised by the FDA in its July 24, 2018 "It Has Come to Our Attention" letter.  Sciton worked with the FDA in a...

05:00
OBI Pharma, Inc., a Taiwan biopharma company (TPEx: 4174), today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for OBI-888 for the treatment of Pancreatic Cancer. OBI-888 is a first in class monoclonal...


20 november 2018

10:37
The U.S. Food and Drug Administration today approved Gamifant (emapalumab) for the treatment of pediatric (newborn and above) and adult patients with primary hemophagocytic lymphohistiocytosis (HLH) who have refractory, recurrent or progressive...

08:00
Pliant Therapeutics, Inc., a biotechnology company focused on discovering, developing and commercializing treatments for fibrotic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for the...

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 november 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 november 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 november 2018

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 november 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 november 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 november 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 november 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 november 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 november 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 november 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...