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MAYNE PHARMA: FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents.
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JOHNSON & JOHNSON: U.S. FDA Grants Priority Review of INVOKANA® (canagliflozin) sNDA for the Treatment of Chronic Kidney Disease in Patients with Type 2 Diabetes
If approved, INVOKANA® will be the first and only therapy in nearly 20 years indicated to reduce the risk of kidney failure when added to current standard of care
TAKEDA PHARMACEUTICALS: U.S. FDA Approves GATTEX® (teduglutide) for Children 1 Year of Age and Older With Short Bowel Syndrome (SBS)
GATTEX is the only glucagon-like peptide-2 (GLP-2) analog approved that improves intestinal absorption in patients with SBS who are dependent on parenteral support (PS)
AYALA PHARMACEUTICALS, INC.: FDA Grants Orphan Drug Designation to Ayala’s AL101 for Potential Treatment of Adenoid Cystic Carcinoma (ACC)
Ayala Pharmaceuticals, a clinical-stage company developing medicines for cancers that are genetically defined, announced today that it has been granted Orphan Drug Designation from the U.S. Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) for AL101, a potent and selective inhibitor of gamma secretase-mediated Notch signalling, for the treatment of ACC.
ALIVECOR: FDA Grants First Ever Clearance For Six-Lead Personal ECG Device
KardiaMobile® is the Only Personal ECG that Delivers Multi-Dimensional Insight into a Patient's Heart
WEST CANCER CENTER: FDA-Approved, Innovative Treatment for Glioblastoma (GMB) Cancer at West Cancer Center
Optune®, a wearable, portable device from Novocure delivers Tumor Treating Fields (TTFields) to slow down or stop GBM cancer cells from dividing, and destroys the cancer without disrupting healthy, resting cells
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SELENBIO, INC.: Texas-Based Biotech Company To Launch FDA-Approved Product Geared Toward Healthier Pets
Pet lovers and veterinarians stay tuned. Texas-based SelenBio is soon to launch an effective breakthrough in helping to prevent gum disease in dogs and cats.
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POLYTECH HEALTH & AESTHETICS GMBH: Welcomes Statement by US Food and Drug Administration FDA Opposing Ban on Textured Breast Implants
POLYTECH Health & Aesthetics GmbH, a global leader in breast aesthetics, welcomes a recent statement by the FDA that textured breast implants will remain available in the US market, In opposition to the recent decision by the French health authority ANSM (Agence Nationale de Sécurité du Médicament) to ban 'macrotextured' and polyurethane coated implants from the French market.
AIDOC: FDA Clears the World's First AI Solution for Flagging Pulmonary Embolism
Aidoc now leads the way in FDA approved AI solutions for radiologists
DAIICHI SANKYO: FDA Oncologic Drugs Advisory Committee Votes in Favor of Daiichi Sankyo's Pexidartinib for the Treatment of Select Patients with TGCT, a Rare, Debilitating Tumor
If approved by the FDA, pexidartinib would be the first and only approved therapy for tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery
EMD SERONO: FDA Approves BAVENCIO® (avelumab) Plus INLYTA® (axitinib) Combination for Patients with Advanced Renal Cell Carcinoma
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has approved BAVENCIO® (avelumab) in combination with INLYTA® (axitinib) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).
ELI LILY AND COMPANY: Lilly's CYRAMZA® (ramucirumab) Becomes First FDA-Approved Biomarker-Driven Therapy in Patients with Hepatocellular Carcinoma
Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved CYRAMZA® (ramucirumab injection, 10 mg/mL solution), as a single agent, for the treatment of patients with hepatocellular carcinoma (HCC) who have an alpha-fetoprotein (AFP) of ≥400 ng/mL and have been treated with sorafenib.
REGENERON: FDA Approves EYLEA® (aflibercept) Injection for Diabetic Retinopathy
EYLEA improves diabetic retinopathy and prevents worsening disease that can lead to blindness
PFIZER, INC.: U.S. FDA Approves VYNDAQEL® and VYNDAMAX™ for Use in Patients with Transthyretin Amyloid Cardiomyopathy, a Rare and Fatal Disease
First and only medicines approved for patients with either wild-type or hereditary transthyretin amyloid cardiomyopathy
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MYLAN N.V.: Mylan Expands Oncology Portfolio with Launch of Generic Tarceva® Tablets
Erlotinib Hydrochloride Tablets treat metastatic non-small cell lung and pancreatic cancers
SUNOVION PHARMACEUTICALS, INC.: Sunovion and PsychoGenics Announce that SEP-363856 Has Received FDA Breakthrough Therapy Designation for the Treatment of People with Schizophrenia
SEP-363856 offers an innovative approach to the treatment of schizophrenia including the potential to be the first agent for the treatment of schizophrenia that does not bind to dopamine 2 (D2) receptors
TAKEDA PHARMACEUTICAL COMPANY: U.S. Food & Drug Administration Accepts Takeda’s Biologics License Application for a Subcutaneous Formulation of Vedolizumab (Entyvio®) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis
An additional treatment modality would provide more flexibility in how patients receive vedolizumab, a biologic with a gut-selective mode of action
ACELITY, INC.: PREVENA™ Therapy Becomes the First and Only Negative Pressure Medical Device FDA-Indicated to Aid in the Reduction of Superficial Surgical Site Infections (SSIs) in Patients at High Risk for Post-Operative Infections
Robust Clinical Evidence Supports PREVENATM Therapy Effectiveness in Reducing SSIs in a Range of Medical Specialties
OPTINA DIAGNOSTICS: Receives Breakthrough Device Designation from U.S. FDA for a Retinal Imaging Platform to Aid in the Diagnosis of Alzheimer's Disease
Optina Diagnostics announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its retinal imaging platform (CAPRS1/MHRC2).