Le Lézard

News by subject: FDA

6 november 2018

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 november 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 november 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 november 2018

09:00
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. The Fusion Bx 2.0 is now available for sale in...

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 To accelerate the development of this new drug, Senhwa followed the latest draft guidance released by FDA for clinical...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 october 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 october 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 october 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 october 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 october 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...


24 october 2018

13:02
Today, the U.S. Food and Drug Administration approved Xofluza (baloxavir marboxil) for the treatment of acute uncomplicated influenza (flu) in patients 12 years of age and older who have been symptomatic for no more than 48 hours....

09:56
Bayer Inc. announced today that Health Canada has approved Jivi® (Antihemophilic Factor [Recombinant, B-domain deleted, PEGylated]) for routine prophylactic treatment to prevent or reduce the frequency of bleeding episodes in previously treated...

08:42
Inova Diagnostics, a world leader in autoimmune disease diagnostic systems and reagents for the clinical laboratory, is proud to announce the clearance by the US Food and Drug Administration (FDA) of a Fecal Extraction Device for use in conjunction...


23 october 2018

11:46
MYR Pharma today announced that US Food and Drug Administration (FDA) has granted the Breakthrough Therapy designation for its lead compound Myrcludex. The designation is granted in the indication chronic hepatitis delta (HDV) infection. The...

11:45
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Clobazam Tablets, CIV, generic for Onfi® Tablets by Lundbeck.  Breckenridge's...

09:30
Monteris Medical, the leader in minimally invasive image-guided thermal therapy, today announced it has received clearance from the U.S. Food and Drug Administration (FDA) for its NeuroBlate® Optictm Laser Probe, a laser probe with fiber optic...

09:22
COMPASS Pathways, a life sciences company dedicated to accelerating patient access to evidence-based innovation in mental health, has received Breakthrough Therapy designation from the US Food and Drug Administration (FDA) for its psilocybin therapy...

09:00
Duchesnay Inc., a pharmaceutical company specializing in women's health, announced today that it has submitted a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) seeking a new indication for Osphena® (ospemifene)....

09:00
SCYNEXIS, Inc. , a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, today announced the successful completion of an End-of-Phase 2 Meeting with the U.S. Food and Drug Administration...

08:01
Seqirus, a global leader in influenza prevention, today announced the U.S. Food and Drug Administration (FDA) has approved AFLURIA® QUADRIVALENT (Influenza Vaccine) for use in people six months of age and older,1 extending the company's broad...

07:30
Amneal Pharmaceuticals, Inc. , today announced that it has received FDA approval for a generic version of Onfi®  (clobazam) tablets, 10 mg and 20 mg for oral use, CIV, and Onfi ® (clobazam) oral suspension, 2.5 mg/mL ,CIV....


22 october 2018

10:06
Analgesic Solutions LLC is proud to announce Greenwich Bioscience's EPIDIOLEX marks the first medication approval and scheduling decision supported by data from the Misuse, Abuse and Diversion Drug Event Reporting System (MADDERS®). EPIDIOLEX was...

08:55
Takeda Pharmaceuticals U.S.A., Inc. ("Takeda") and Lundbeck today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for TRINTELLIX® (vortioxetine), a prescription medication used for adults...

08:00
Eiger BioPharmaceuticals, Inc. , focused on the development and commercialization of targeted therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to...

07:00
Regeneron Pharmaceuticals, Inc. and Sanofi today announced the U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an...

03:00
Biohaven Pharmaceutical Holding Company Ltd. , a biotechnology company focused on advancing innovative therapies for neurological diseases, today announced that the first participant was dosed with BHV-3500, a third generation calcitonin gene-related...

03:00
OssDsign AB, the Swedish designer, manufacturer and distributor of regenerative implants for cranial and facial reconstruction, today announced that it has received 510(k) clearance by the US FDA for marketing and sale of its...


19 october 2018

17:55
Sanofi (EURONEXT: SAN) The U.S. Food and Drug Administration has approved Dupixent® (dupilumab) as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older with an eosinophilic phenotype or with oral...

17:55
Only biologic approved for both moderate and severe asthma patients with eosinophilic phenotype Only biologic approved for oral corticosteroid-dependent asthma, regardless of phenotype Only asthma biologic that offers patient self-administration at...

09:00
Abbott announced today that the HeartMate 3tm Left Ventricular Assist Device (LVAD) has received U.S. Food and Drug Administration (FDA) approval as a destination therapy for people living with advanced heart failure. With the approval, physicians...

08:00
Amneal Pharmaceuticals, Inc. , today announced that it has received FDA approval for a generic version of BiCNU®  (carmustine) for injection, 100 mg. The Company is planning to commercialize its Carmustine for Injection in November 2018....

07:30
Amneal Pharmaceuticals, Inc. , today announced that it has received FDA approval for a generic version of IsuprelTM Injection (isoproterenol hydrochloride) USP, 0.2 mg/mL and 1 mg/5 mL(0.2 mg/mL) Single-Dose Vials. The Company has immediately...


18 october 2018

11:39
MC3 (mc3corp.com) today announced the launch of the Crescenttm Jugular Dual Lumen Catheter, the first such device cleared by FDA for ECMO (Extracorporeal membrane oxygenation) in the United States. MC3's Crescent catheter is placed through the...

10:00
Ascent Industries Corp. ("Ascent" or the "Company") would like to provide an update regarding the press release issued by the Company on September 27th relating to the partial suspension of the Health Canada licenses issued to its wholly owned...


17 october 2018

16:05
Natura Naturals Inc. ("Natura") has received Health Canada approval to add "Grow Space 3" and "Grow Space 4" to their current ACMPR license. Grow Space 3 provides approximately 39,000 square feet of flowering area and Grow Space 4 provides...

15:00
The OMNIStethtm is the first stethoscope designed specifically for telemedicine. Various methods of connection to your video conferencing platform and intuitive adjustments maximize the sound quality and performance during an exam. The OMNIStethtm...

08:26
Ascensia Diabetes Care today announced the receipt of an amended license from Health Canada for the CONTOUR® NEXT LINK 2.4 blood glucose meter to be used with the new Medtronic MiniMedtm 670G insulin pump system with SmartGuardtm algorithm. ...


16 october 2018

09:00
Allergan plc , a leading global pharmaceutical company, and Medicines360, a global nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, announced that the U.S. Food and Drug Administration (FDA)...

08:15
The Green Organic Dutchman Holdings Ltd. (the "Company" or "TGOD") (US:TGODF) is pleased to announce it has received its medical sales license from Health Canada pursuant to the Access to Cannabis for Medical Purposes Regulations (the "ACMPR") for...

06:18
Alphamab Oncology announced that it has received US FDA's IND approval for its proprietary HER2 bispecific antibody (product code: KN026), and KN026 is anticipated to enter clinical development later in the US. With the earlier IND approval for KN026...

06:17
Cellenkos, Inc., a clinical-stage biotechnology company, announced that the United States Food and Drug Administration has cleared its Investigational New Drug (IND) application to proceed with a phase I clinical trial of CK0801, allogeneic cord...