Le Lézard

News by subject: FDA

2 october 2018

08:07
Today QOL Medical, LLC announced that the U.S. Food and Drug Administration (FDA) has approved the company's wholly owned manufacturing facility in Clearwater, Florida to manufacture sacrosidase, the drug substance used to make Sucraid® (sacrosidase)...

06:07
QOL Medical, LLC today announced that the U.S. Food and Drug Administration (FDA) has approved its new, state-of-the-art manufacturing facility in Florida. The supply of Sucraid® (sacrosidase) Oral Solution has been restored. QOL Medical, LLC is now...


1 october 2018

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for KYPROLIS® (carfilzomib) to include a once-weekly dosing option in combination...

08:32
Infinity Pharmaceuticals, Inc. announced today that it earned a $22 million payment from Verastem Oncology under the license agreement between the Company and Verastem for COPIKTRA (duvelisib).  The payment was earned upon the approval by the U.S....


29 september 2018

23:00
Innovent Biologics, Inc. (Innovent), a world-class China-based biopharmaceutical company that develops high quality drugs, announced yesterday that its IND application for IBI-188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has...


28 september 2018

17:22
The U.S. Food and Drug Administration today approved a new drug, Arikayce (amikacin liposome inhalation suspension), for the treatment of lung disease caused by a group of bacteria, Mycobacterium avium complex (MAC) in a limited population of...

16:51
The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for...

16:39
Libtayo is the third anti-PD-1 approved in the U.S. CSCC is the second most common skin cancer in the U.S. Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Libtayo®...

16:29
Today the U.S. Food and Drug Administration permitted marketing of ClonoSEQ assay, a next generation sequencing (NGS)-based test for minimal residual disease (MRD) in patients with acute lymphoblastic leukemia (ALL) or multiple myeloma. MRD is a...

14:54
Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) expanded the indication of its antiepileptic drug FYCOMPA® (perampanel) CIII for monotherapy and adjunctive use in pediatric patients 4 years and older for the treatment of...

08:00
TransThera Biosciences Co. Ltd, announced today that the company received FDA IND application approval for TT-00420, a novel small molecule investigational drug targeting Triple-Negative Breast Cancer (TNBC). TT-00420 is a selectively clustered...


27 september 2018

19:52
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved Emgalitytm (galcanezumab-gnlm) 120 mg injection for the preventive treatment of migraine in adults.1 Emgality offers a once-monthly,...

16:05
Sandoz Inc. today announced that the US Food and Drug Administration has approved SYMJEPItm (epinephrine) 0.15 mg Injection for the emergency treatment of allergic reactions in children. Sandoz will distribute and commercialize SYMJEPItm...

12:49
HighTide Therapeutics Inc., a globally focused 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 primary sclerosing...

08:00
Profounda, Inc. ("Profounda") announced today that it has received the US Food and Drug Administration's Competitive Generic Therapy (CGT) Designation for the planned future ANDA filing of Minocycline Hydrochloride Microspheres, 1 mg, pursuant to...


26 september 2018

09:59
IDx, the company that has developed the first and only FDA-cleared autonomous AI diagnostic system, has secured significant venture capital funding to accelerate market adoption and further develop additional diagnostic systems for its AI platform....

08:38
OrthoXeltm is a specialist orthopaedic trauma company, using innovative engineering design to evolve truly next generation fracture fixation devices. OrthoXeltm is delighted to announce that the new Apex Femoral Nailing System has been granted US FDA...

07:30
Allergan plc , a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine), seeking to expand the...

06:00
INSIGHTEC®,a global medical technology innovator of incisionless surgery, today announced that the U.S. Food and Drug Administration (FDA) has approved Exablate Neurotm compatibility for the state-of-the-art MRI Scanners Magnetom Skyra, Prisma and...

05:00
Renovis Surgical Technologies, Inc. today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Tesera® X Lateral Interbody Fusion System. Tesera X is the latest...

02:00
Aronora Inc., a clinical stage biotechnology company developing first-in-class treatments for life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for proCase (E-WE thrombin,...


25 september 2018

06:30
The privately-owned company, MT.DERM GmbH, Berlin, Germany, a manufacturer of medical microneedling, micropigmentation and tattoo equipment is excited to announce its expansion into the US market of its medical microneedling device, Exceed under the...


24 september 2018

08:00
Alnylam Pharmaceuticals, Inc. , the leading RNA interference (RNAi) therapeutics company, announced today that Health Canada has granted Priority Review status to patisiran. Priority review is granted to regulatory filings in Canada intended for new...

06:45
Today, Boston Scientific announced that the U.S. Food and Drug Administration (FDA) has approved its Premarket Approval (PMA) application to market the Eluviatm Drug-Eluting Vascular Stent System, specifically developed for the treatment of...


21 september 2018

13:30
Captiva Spine is a medical device organization located in Jupiter, Florida, dedicated to delivering smart, elegant and intuitive spinal fusion solutions. Today, Captiva Spine is announcing it has received 510(k) clearance from the U.S. Food and Drug...


20 september 2018

17:05
Vanda Pharmaceuticals Inc. (Vanda) today announced that a HETLIOZ® patent, number 10,071,977 ('977 patent), is now listed in the U.S. Food and Drug Administration publication Approved Drug Products With Therapeutic Equivalence Evaluations, commonly...

05:00
Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its augmented reality GLOW800 surgical fluorescence for vascular neurosurgery. In combination with ICG (Indocyanine Green), GLOW800 allows...


19 september 2018

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 (ODD) for OBI-3424 for the Treatment of Acute Lymphoblastic Leukemia (ALL). OBI-3424 is a...

01:00
Additional clinical trial data for prophylaxis of HAE requested Pharming Group N.V. ("Pharming" or "the Company") (Euronext Amsterdam: PHARM) announced today that it received a Complete Response Letter (CRL) from the U.S. Food and Drug...


18 september 2018

16:30
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that a New Drug Application (NDA) has been submitted to the U.S. Food and Drug Administration (FDA) seeking approval of erdafitinib for the treatment of patients with locally...

15:13
Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to...

08:45
Healcerion today announced the SONON 300L will be unveiled to the US market with live demos at booth #722 in the New Exhibitor Pavilion at FMX Family Medicine Experience Show 2018, October 9-13, Ernest N. Morial Convention Center, New Orleans, LA....

08:10
Contego Medical announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the first filter-based Integrated Embolic Protection (IEP) device, the Paladin® Carotid PTA Balloon System. Contego Medical is...

08:05
FDA & USDA announced they have approved Phageguard-E as a "GRAS" (Generally Recognized as Safe) food processing aid against E.coli O157. The new product consists of natural phages against E.coli and is produced by Micreos of The Netherlands. The...

07:00
Bayer Inc. has announced that Health Canada has approved XARELTO® (rivaroxaban) film-coated tablet (2.5 mg), in combination with 75 mg ? 100 mg acetylsalicylic acid (ASA)* for the prevention of stroke, myocardial infarction and cardiovascular death,...


17 september 2018

10:35
Oramed Pharmaceuticals Inc. (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New...

09:00
WAT Medical's innovative technology to treat all primary headaches, HeadaTerm, received its FDA clearance in September 2018. This product, already approved by CE, HC, and now FDA, has been distributed in over 20 countries around the world. It has now...

08:01
Sebacia, Inc., a privately held, commercial stage dermatology and aesthetics company, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its lead product, Sebacia Microparticles. This significant achievement is...

08:00
Halozyme Therapeutics, Inc. today announced that Roche has received approval from Health Canada for a subcutaneous (SC) formulation of trastuzumab (Herceptin SC) for the treatment of patients with HER2-positive breast cancer. This is a...


14 september 2018

13:26
BIOTRONIK today announced the FDA approval of the PK Papyrus covered coronary stent system under Humanitarian Device Exemption for use in the emergency treatment of acute coronary perforations.1,2 PK Papyrus received CE marking in 2013....

12:45
The U.S. Food and Drug Administration today approved a device intended to treat acute coronary artery perforations, or tears in the blood vessels of the heart. The PK Papyrus Covered Coronary Stent System is the first device approved by the FDA for...


13 september 2018

14:18
The U.S. Food and Drug Administration today approved Lumoxiti (moxetumomab pasudotox-tdfk) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior...

10:00
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedures, among other core businesses, announced today the FDA clearance of its EZ Shot 3 Plus 25 G needle as well as an expanded...

08:00
BTG plc (LSE: BTG) announced that the US Food & Drug Administration (FDA) has approved updating the shelf life of CroFab® Crotalidae Polyvalent Immune Fab (Ovine) to 60 months and the removal of mercury from the product's manufacturing process. The...

06:30
Ardelyx, Inc. , today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting U.S. marketing authorization of tenapanor for the treatment of patients with irritable bowel syndrome with...


12 september 2018

07:30
Amneal Pharmaceuticals, Inc. , today announced it has received U.S. Food and Drug Administration (FDA) approval on its Abbreviated New Drug Application (ANDA) for Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg and...

06:00
Exact Imaging (www.exactimaging.com), the world's leader in high resolution micro-ultrasound systems enabling real-time imaging and biopsy guidance for the prostate, announced it has received Health Canada approval for its FusionVutm application for...

00:59
Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The sBLA outlines a...


10 september 2018

18:03
AliveCor, recently recognized as the Most Innovative Company in Artificial Intelligence, today announced that the U.S. Food and Drug Administration has given the company's KardiaK Software Platform the rarely granted designation of "Breakthrough...

15:30
The U.S. Food and Drug Administration (FDA) has recommended amendment of the Association of American Feed Control Officials (AAFCO) ingredient definition of dried black soldier fly larvae (BSFL) to include feeding to poultry.  The approval of BSFL...