FDA Approvals
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The Complete Response Letter indicated the company will need to run an “adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.”
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Dominion Aesthetic Technologies Announces FDA Clearance of eon™ FR, Non-Contact Body Sculpting
6/25/2019
eon FR is body shaping technology that delivers non-contact, laser energy to reduce fat in the abdomen
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Bausch Health Announces U.S. Launch of DUOBRII™ (halobetasol propionate and tazarotene) Lotion 0.01%/0.045% for Plaque Psoriasis in Adults
6/25/2019
DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation.
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July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.
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Ipsen Announces U.S. FDA Approval for Newly Designed Pre-Filled Syringe for Somatuline® Depot (lanreotide)
6/24/2019
Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved a new pre-filled syringe for Somatuline® Depot (lanreotide).
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Micro Medical Solutions Receives FDA IDE Approval for Pivotal Clinical Trial of MicroStent
6/24/2019
Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA)
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New Studies Highlight Activity of XERAVA™ Against Gram-Negative and Gram-Positive Clinical Isolates, Including Multidrug-Resistant Pathogens
6/24/2019
Tetraphase Pharmaceuticals, Inc. announced the presentation of new data on XERAVA™, a novel, fully synthetic fluorocycline approved by the U.S. Food and Drug Administration and the European Medicines Agency for the treatment of complicated intra-abdominal infections in adults, and TP-6076, a clinical-stage candidate targeting multidrug-resistant infections, at the American Society for Microbiology Microbe 2019 Annual Meeting held June 20-24 in San Francisco.
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Minerva Biotechnologies Announces FDA Acceptance of IND Application for huMNC2-CAR44 T cells to Treat Metastatic Breast Cancer
6/24/2019
Unlike the normal full-length MUC1, MUC1* is a potent growth factor receptor that is rendered constitutively active when onco-embryonic growth factor NME7AB binds to and dimerizes its truncated extracellular domain.
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Allergan Receives FDA Clearance For CoolTone™ Device
6/24/2019
Magnetic muscle stimulation technology to strengthen, tone and firm muscles
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FDA Grants Orphan Drug Designation to XW Laboratories' XWL-008 for the Treatment of Patients with Narcolepsy
6/24/2019
XW Laboratories Inc. announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to the company's lead proprietary compound XWL-008 for the treatment of patients with narcolepsy.
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Allergan announced that the U.S. Food and Drug Administration has approved its wrinkle treatment Botox for children with upper limb spasticity. The news comes just days after rumors that the company may break up.
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FDA Approves SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) to Treat the Underlying Cause of CF in Children Ages 6-11 Years with Certain Mutations in the CFTR Gene
6/21/2019
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved SYMDEKO® (tezacaftor/ivacaftor and ivacaftor) for use in children with cystic fibrosis ages 6 through 11 years who have two copies of the F508del-CFTR mutation or who have at least one mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to SYMDEKO
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FDA expands approval of treatment for cystic fibrosis to include patients ages 6 and older
6/21/2019
The U.S. Food and Drug Administration today expanded the indication for Symdeko (a combination of tezacaftor/ivacaftor) tablets for treatment of pediatric patients ages 6 years and older with cystic fibrosis who have certain genetic mutations.
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Ocular Therapeutix™ Announces FDA Approval of Supplemental New Drug Application (sNDA) for DEXTENZA® (0.4 Dexamethasone Intracanalicular Insert for Ophthalmic Use) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
6/21/2019
DEXTENZA® Now Approved for the Treatment of Ocular Inflammation and Pain Following Ophthalmic Surgery
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Arrowhead Pharmaceuticals Receives Orphan Drug Designation for ARO-APOC3
6/21/2019
Arrowhead Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration has granted orphan drug designation to ARO-APOC3 for the treatment of familial chylomicronemia syndrome.
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FDA Approves BOTOX® (onabotulinumtoxinA) for Pediatric Patients with Upper Limb Spasticity
6/21/2019
BOTOX® is the First Neurotoxin Treatment Approved to Treat Pediatric Patients, 2 to 17 Years of Age, with Upper Limb Spasticity
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FDA Approves New Drug Application for Vyleesi™ (bremelanotide injection)
6/21/2019
Palatin Technologies, Inc. (NYSE American: PTN) announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval of AMAG Pharmaceuticals, Inc.'s New Drug Application (NDA) for Vyleesi
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FDA approves new treatment for hypoactive sexual desire disorder in premenopausal women
6/21/2019
The U.S. Food and Drug Administration today approved Vyleesi (bremelanotide) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women.
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ANI Pharmaceuticals Announces Approval of Vancomycin Hydrochloride for Oral Solution USP, 250mg/5ml
6/20/2019
ANI Pharmaceuticals, Inc. ("ANI") (Nasdaq: ANIP) today announced that it has received FDA approval of its Prior Approval Supplement for Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 ml, indicated for the treatment of various infections
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Edesa Biotech Receives Approval to Proceed with U.S. Clinical Study
6/20/2019
Edesa Biotech, Inc. reported that the U.S. Food and Drug Administration has notified the company that it may proceed with its clinical investigation of EB01, a novel sPLA2 inhibitor, which Edesa is developing as a potential treatment for chronic allergic contact dermatitis.