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We are proud to announce that the RTI Calibration Laboratory in Mölndal, Sweden, has officially achieved ISO 17025 accreditation for Half Value Layer (HVL) calibration. This milestone allows us to expand our services, offering customers accredited HVL calibration alongside our existing ISO 17025 accredited calibrations for Tube Voltage, Air Kerma, mA/mAs, Luminance, and ...
Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information & Risks: For Indications for Use, Warnings, Precautions, and other safety information, please refer to product ...
Selling or giving away DYANAVEL XR may harm others and is against the law. See additional important safety information below. About Tris Pharma Tris Pharma is a privately held, innovation-driven biopharmaceutical company that is applying its drug development capabilities and proprietary technologies to transform the treatment of ADHD, pain and neurological ...
Patients are advised to consult with a qualified healthcare professional to determine if this product is right for them. Important Safety Information & Risks: For Indications for Use, Warnings, Precautions, and other safety information, please refer to product ...
The results of this trial, including the initial results of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC), will provide long-term safety data and inform the starting dose while further defining the clinical profile of INT301. ...
The approval is based on positive efficacy and safety results of the ILLUMINATE-C Phase 3 study of OXLUMO in patients with severe renal impairment, including those on hemodialysis. ...
Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Ocular Toxicity:Retinal Pigment Epithelial Detachment (RPED), which may cause symptoms such as blurred vision, occurred in 9% of 318 patients who received LYTGOBI ...
– New Data Further Support Potential for Patisiran to be an Effective Treatment for Cardiomyopathy of ATTR Amyloidosis – – Data from Exploratory Endpoints, Including Cardiac Biomarkers and Imaging, Suggest Favorable Impact of Patisiran on Measures of Cardiac Stress, Injury, Structure, and Function at Month 12 – – Treatment with Patisiran Demonstrated Generally ...
– AMVUTTRA Demonstrated Halting or Reversal in Neuropathy Impairment with Subcutaneous Administration Once Every Three Months – – Decision Follows Positive Opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in July 2022 – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 20, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), ...
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information. U.S. Indication PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 ...
– Company to Webcast Investor Event on September 30th at 8:00 p.m. ET – CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sep. 13, 2022-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the Company will present additional data from the APOLLO-B Phase 3 study of patisiran, an investigational RNAi therapeutic in development for the treatment ...
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information. U.S. Indication PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years ...
PreHevbrio is approved for use in adults 18 years of age and older. U.S. Important Safety Information (ISI) Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio. ...
PreHevbrio is approved for use in adults 18 years of age and older. U.S. Important Safety Information (ISI) Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio. ...
“We are pleased to announce this latest regulatory approval of PreHevbri, our third in the span of six months, and another significant milestone in our efforts to broaden access to our differentiated 3-antigen vaccine,” said Jeff Baxter, VBI’s President and CEO. “Based upon the safety and immunogenicity profiles observed in the PROTECT and CONSTANT pivotal ...
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio™ [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information. Full European Summary of Product Characteristics for PreHevbri are available from the European Medicines Agency (EMA) website at www.ema.europa.eu. ...
THOUSAND OAKS, Calif., May 12, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Otezla® (apremilast) have partnered with pop icon and entrepreneur Lance Bass, for the Double Take campaign to empower people to take action when it comes to psoriatic arthritis. As a singer, dancer and entertainer, Bass understands the importance of staying in tune with your body. Through the campaign, he has created ...
Citrine is headquartered in Shanghai and has other offices in Beijing, China and Cambridge, Mass. For more information, visit www.citrinemed.com About Pitolisant Pitolisant is a selective histamine H3-receptor antagonist/inverse agonist which enhances the activity of histaminergic neurons. ...
Healthcare professionals should read the INSTRUCTIONS FOR USE - RECELL® Autologous Cell Harvesting Device (https://recellsystem.com/) for a full description of indications for use and important safety information including contraindications, warnings, and precautions. ...
Dupixent 300 mg weekly significantly improved the signs and symptoms of EoE at 24 weeks compared to placebo, including the ability to swallow and reduction in eosinophil count in the esophagus. The safety results of these trials were generally consistent with the known safety profile of Dupixent in its approved indications. ...