Le Lézard

News by subject: FDA

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12 february 2019

05:48
Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Primary biliary cholangitis (PBC). More information about...

05:45
Calliditas Therapeutics AB (publ) ("Calliditas") today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Primary biliary cholangitis (PBC). More information about...


11 february 2019

17:44
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License...

08:30
BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other acquired traumatic brain injuries, today announced that the U.S....

08:00
Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, announced today that the U.S. Food and Drug Administration (FDA) Office of Orphan Product Development has granted orphan drug designation to APX001,...

07:30
Precigen, Inc., a wholly-owned subsidiary of Intrexon Corporation and a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug...


7 february 2019

12:31
Grifols, a leading global producer of plasma-derived medicines and a leader in the development of innovative diagnostic solutions, announced today that the U.S. Food and Drug Administration (FDA) approved the Procleix Babesia assay, a qualitative...

08:45
In the industries regulated by FDA, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be...

08:00
Endo International plc ("Endo") today announced that the U.S. Food and Drug Administration (the "FDA") has requested a further stay of Endo's ongoing litigation against the FDA through March 15, 2019.  That litigation challenges the FDA's...


6 february 2019

11:53
The U.S. Food and Drug Administration (FDA) has approved Cablivi® (caplacizumab-yhdp) in combination with plasma exchange and immunosuppression for the treatment of acquired thrombotic thrombocytopenic purpura (aTTP) in adults.  Cablivi is the first...

11:25
The U.S. Food and Drug Administration today approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for the treatment of adult patients with acquired...

08:45
Perrigo Company plc  today announced it has received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application referencing Zovirax® Cream, 5% (acyclovir cream, 5%) developed in collaboration with...


5 february 2019

13:30
Cytogel Pharma, LLC. today announced receipt of the official response from the U.S. Food and Drug Administration (FDA) regarding the Company's amendment to the Complete Response Letter (CRL) for the CYT-1010 Investigational New Drug (IND)...

10:26
Flowonix Medical, Inc. today announced United States Food and Drug Administration (FDA) approval to market the Flowonix Maestrotm Software for Clinician Programmers used to program Prometra® Pump Systems. The new software is designed to improve the...


4 february 2019

07:00
BioLineRx Ltd. , a clinical-stage biopharmaceutical company focused on oncology, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead oncology candidate, BL-8040, for the treatment of...


31 january 2019

14:59
Mylan N.V. today announced the U.S. Food and Drug Administration (FDA) approval of Wixelatm Inhubtm (fluticasone propionate and salmeterol inhalation powder, USP), the first generic of ADVAIR DISKUS®. Experience the interactive Multichannel News...

06:45
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted approval for a new indication for ALIMTA® (pemetrexed for injection) in combination with KEYTRUDA® (pembrolizumab), developed and marketed by Merck...


30 january 2019

15:40
The U.S. Food and Drug Administration today approved the first generic of Advair Diskus (fluticasone propionate and salmeterol inhalation powder) for the twice-daily treatment of asthma in patients aged four years and older and maintenance treatment...

09:00
Neurelis announced today that its Intravail® licensing partner, Dr. Reddy's Laboratories and its U.S. subsidiary, Promius Pharma, LLC, received U.S. Food and Drug Administration (FDA) approval of TOSYMRAtm (sumatriptan nasal spray 10 mg). ...

08:54
SpeakEasy Cannabis Club Ltd.  (the "Company" or "SpeakEasy") is pleased to announce that it has been informed that the Company has successfully completed the Heath Canada committee review and would not be required to supply any further information...

08:00
Volpara Solutions, Inc. recently announced that it has received FDA 510(k) clearance for technologies used in the Volpara®Densitytm clinical application, the benchmark in breast density assessment. The updated version of VolparaDensity more...


29 january 2019

19:46
Qualigen, Inc., a privately-owned company that provides novel diagnostic and therapeutic technologies for the treatment of cancer and infectious diseases, today announced that the Company has received clearance from the U.S. Food and Drug...

10:07
MediPines Corporation announced today it has received FDA 510(k) market clearance on its new non-invasive medical device, the MediPines Gas Exchange Monitor. The MediPines Gas Exchange Monitor provides clinicians with real-time pulmonary parameters...

08:30
Trovagene, Inc. , a clinical-stage oncology therapeutics company, developing drugs that target cell division (mitosis) for the treatment of leukemias, lymphomas and solid tumor cancers, today announced an agreement with PoC Capital, LLC, to fund...


28 january 2019

20:00
Over-the-counter pain-relief products have a new competitor. Mineralgia, the first FDA-approved pain-relief cream that is 98 percent natural, was introduced at this week's Indie Beauty Expo in Los Angeles. Based on concentrated healing minerals from...

07:05
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with obinutuzumab in treatment-naïve patients with chronic lymphocytic...

07:00
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) in combination with obinutuzumab (GAZYVA®) for adult patients with previously...


25 january 2019

09:02
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, today announced U.S. Food and Drug Administration 510(k) clearance of the ROSA® Knee System for robotically-assisted total knee replacement surgeries. ROSA Knee features 3D...


24 january 2019

10:07
CorMatrix® Cardiovascular, Inc. www.cormatrix.com, a leading developer of regenerative cardiovascular medical devices, today announced FDA approval of an early feasibility study IDE to evaluate the safety and feasibility of the Cortm TRICUSPID ECM®...

09:01
Amerigen Pharmaceuticals Limited ("Amerigen") today announced that its Abbreviated New Drug Application ("ANDA") for a generic version of Shire's Adderall XR® (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, announced the U.S. Food and Drug Administration 510(k) clearance of its second generation BD Nanotm pen needle, designed for more reliable subcutaneous injection depth....


23 january 2019

16:21
The U.S. Food and Drug Administration today permitted marketing of a new test to aid in the diagnosis of a sexually-transmitted infection (STI) called Mycoplasma genitalium (M. gen.). This is the first test authorized by the FDA to test for the M....

14:53
The U.S. Food and Drug Administration has approved the use of the 0.5 mL dose of Fluzone® Quadrivalent (influenza vaccine) to include children age 6 through 35 months. Sanofi Pasteur, the vaccine division of Sanofi, will have the 0.5 mL dose, in...

03:00
Biohaven Pharmaceutical Holding Company Ltd. ("Biohaven") announced today the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its clinical investigation of BHV-3241, a novel myeloperoxidase (MPO) inhibitor,...


22 january 2019

12:00
23andMe, Inc., the leading personal genetics company, today received FDA clearance for a genetic health risk report on a hereditary colorectal cancer syndrome. The clearance follows the FDA's authorization for 23andMe's...

09:04
I-Mab Biopharma ("I-Mab"), a China-based clinical stage biopharmaceutical company exclusively focused on the development of innovative biologics in immuno-oncology and autoimmune diseases, announced on January 18th, 2019 that the Investigational New...

08:00
Alliance Contract Pharma (ACP) is pleased to announce that one of our clients has received FDA approval for the first twice-daily ocular corticosteroid indicated for the treatment of post-operative inflammation and pain following ocular surgery. This...

08:00
A new test from Thermo Fisher Scientific helps allergists and other medical providers better predict which patients may be at risk for life-threatening sensitization to Ara h 6, a protein component in peanuts that can cause severe allergic reactions...

08:00
United Imaging Healthcare (United Imaging), an international leader in advanced medical imaging and radiotherapy equipment, today announced US Food & Drug Administration (FDA) clearance of the uEXPLORER total-body scanner. uEXPLORER is the world's...


21 january 2019

09:00
Abbott  today announced U.S. Food and Drug Administration (FDA) approval of the TactiCathtm Contact Force Ablation Catheter, Sensor Enabledtm, a new ablation catheter designed to help physicians accurately and effectively treat atrial fibrillation...


16 january 2019

17:41
Amgen and UCB (Euronext Brussels: UCB) today announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of EVENITYtm* (romosozumab) for the treatment...

12:32
The U.S. Food and Drug Administration approved the first generic version of Sabril (vigabatrin) 500 mg tablets for treating complex partial seizures, also called focal seizures, as an adjunctive therapy (given with another primary treatment) in...

12:10
Immuno Concepts, a recognized pioneer in innovation of autoimmune diagnostic reagents and instrumentation, is pleased to announce that the United States Food and Drug Administration (FDA), through the 510(k) process, has cleared the Histofluor®...

10:30
MIM Software Inc., a leading global provider of medical imaging software, announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for molecular radiotherapy (MRT) dosimetry. MRT...

10:10
Acurx Pharmaceuticals, LLC ("Acurx" or the "Company"), a clinical stage, privately-held biopharmaceutical company focused on developing new antibiotics for difficult-to-treat bacterial infections, announced today that the U.S. Food and Drug...

09:00
Bridge Biotherapeutics Inc., a clinical stage biotech company headquartered in Seongnam, South Korea and a tenant company of JLABS@TMC in Houston, Texas, announced that the U.S. Food and Drug Administration (FDA) has granted an orphan drug...

08:00
Therachon AG ("Therachon"), a clinical-stage biotechnology company focused on the discovery, development and commercialization of innovative treatments for serious rare conditions, today announced that the U.S. Food and Drug Administration (FDA) has...


15 january 2019

08:19
Beleave Inc. ("Beleave" or the "Company") is excited to announce its wholly-owned subsidiary Beleave Kannabis Corp. has been authorized by Health Canada to sell cannabis oil products effective January 11, 2019. After reviewing the application and...


14 january 2019

16:47
The U.S. Food and Drug Administration has approved the expanded use of Adacel® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) to include repeat vaccination to help protect against tetanus, diphtheria and...

16:00
Additive Orthopaedics, LLC., the leader in 3D printed orthopaedic foot and ankle devices, announces that is has received FDA 510(k) clearance for its Patient Specific 3D Printed Locking Lattice Plates indicated for alignment, stabilization and fusion...

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