Janssen Submits sBLA for Daratumumab Combo to Treat Multiple Myeloma
Janssen Pharmaceutical Companies submitted a supplemental biologics license application for daratumumab in combination with carfilzomib and dexamethasone to treat patients with relapsed/refractory multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - February 11, 2020 Category: Cancer & Oncology Authors: Matthew Fowler Source Type: news

Janssen Announces Submission to U.S. FDA for New DARZALEX ® (Daratumumab)-Based Combination Regimen for Patients with Relapsed/Refractory Multiple Myeloma
RARITAN, NJ, February 10, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX® (daratumumab) in combination with Kyprolis® (carfilzomib) and dexamethasone (DKd) for relapsed/refractory multiple myeloma. The sBLA is supported by results from the Phase 3 CANDOR study, which compared treatment with DKd to carfilzomib and dexamethasone (Kd) in patients with multiple myeloma who relapsed after one to three prior lines of therapy. “W...
Source: Johnson and Johnson - February 10, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

Drug Trials Snapshots: XPOVIO
XPOVIO is a drug used to treat a form of blood cancer called multiple myeloma. It is to be used in combination with dexamethasone (a type of corticosteroid) in patients with no other treatment options whose cancer came back after, or did not respond to, at least four previous treatments. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 27, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Dxevo (Dexamethasone Tablets ) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 11, 2019 Category: Drugs & Pharmacology Source Type: news

New Triplet, New Standard of Care in Relapsed Myeloma? New Triplet, New Standard of Care in Relapsed Myeloma?
A new triplet regimen -- carfilzomib, dexamethasone, and daratumumab -- has shown good results in patients with relapsed or refractory multiple myeloma.Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - December 10, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Featured Review: Reducing uncertainties in choosing first-line treatment in newly diagnosed multiple myeloma
Multiple myeloma is a type of blood cancer. It accounts for approximately 2% of all cancers and is still considered incurable. For people with newly diagnosed multiple myeloma (NDMM), who are unsuitable for a procedure where damaged blood cells are replaced with healthy ones (stem-cell transplant), treatment is usually a multiple drug combination of bortezomib, lenalidomide, or thalidomide, plus melphalan and prednisolone (MP) or dexamethasone (D). Multiple drug combinations are approved for initial anti-myeloma therapy, however, access to these medicines is restricted in many countries worldwide.The Cochrane Review used n...
Source: Cochrane News and Events - November 26, 2019 Category: Information Technology Authors: Katie Abbotts Source Type: news

tobramycin and dexamethasone (Tobradex, Tobradex ST)
Title: tobramycin and dexamethasone (Tobradex, Tobradex ST)Category: MedicationsCreated: 7/23/1998 12:00:00 AMLast Editorial Review: 11/15/2019 12:00:00 AM (Source: MedicineNet Eyesight General)
Source: MedicineNet Eyesight General - November 15, 2019 Category: Opthalmology Source Type: news

Hemady (Dexamethasone Tablets) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - October 9, 2019 Category: Drugs & Pharmacology Source Type: news

Dexamethasone Promotes Fungal Infection By Inhibition of APC Activation with Beta-Glucans Via STAT-3 and NF- κb
Dexamethasone Promotes Fungal Infection By Inhibition of APC Activation with Beta-Glucans Via STAT-3 and NF- κbConference abstracts (Source: The Aspergillus Website - updates)
Source: The Aspergillus Website - updates - October 4, 2019 Category: Respiratory Medicine Authors: MeganB Source Type: news

FDA Approves Darzalex Combo as Frontline Treatment for Myeloma
The combination use of Darzalex with bortezomib, thalidomide, and dexamethasone was approved for transplant-eligible patients with multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - September 26, 2019 Category: Cancer & Oncology Authors: Seth Augenstein Source Type: news

Maxidex Suspension (Dexamethasone Ophthalmic Suspension) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 17, 2019 Category: Drugs & Pharmacology Source Type: news

Maxidex Ointment (Dexamethasone Sodium Phosphate Ophthalmic) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - September 17, 2019 Category: Drugs & Pharmacology Source Type: news

Novel Therapy Treats Triple-Class Refractory Multiple Myeloma
FRIDAY, Aug. 23, 2019 -- The combination of selinexor and dexamethasone seems effective in treating patients with multiple myeloma that has not responded to standard therapies, according to a study published in the Aug. 22 issue of the New England... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - August 23, 2019 Category: Pharmaceuticals Source Type: news

Lucky Mart Inc. Issues Voluntary Nationwide Recall Of Piyanping Anti-Itch Lotion Due to Incorrect Active Ingredient
Lucky Mart Inc. is voluntarily recalling lots C14005, C16001 and C16002 of Piyanping Anti-Itch Lotion to the consumer level. The product was manufactured using the active pharmaceutical ingredient dexamethasone rather than hydrocortisone. Dexamethasone is not listed as an ingredient in the labeling. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 24, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Moffitt research of Selinexor for multiple myeloma facilitates FDA approval
(H. Lee Moffitt Cancer Center& Research Institute) A first-in-class drug recently granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with heavily pretreated multiple myeloma has been the subject of study at Moffitt Cancer Center for years. Now, selinexor (XPOVIO ™ , Karyopharm Therapeutics) used in combination with the corticosteroid dexamethasone will offer another option for patients with multiple myeloma who have exhausted the most common therapies for the disease. (Source: EurekAlert! - Cancer)
Source: EurekAlert! - Cancer - July 24, 2019 Category: Cancer & Oncology Source Type: news

Dexamethasone for Post-op Cognitive Dysfunction Following GA Dexamethasone for Post-op Cognitive Dysfunction Following GA
Might prophylactic dexamethasone reduce post-operative cognitive dysfunction and/or post-operative delirium in adults following general anesthesia?BMC Anesthesiology (Source: Medscape Today Headlines)
Source: Medscape Today Headlines - July 19, 2019 Category: Consumer Health News Tags: Anesthesiology Journal Article Source Type: news

Drug Trials Snapshots: XPOVIO
XPOVIO is a drug used to treat a form of blood cancer called multiple myeloma. It is to be used in combination with dexamethasone (a type of corticosteroid) in patients with no other treatment options whose cancer came back after, or did not respond to, at least four previous treatments. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 17, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Xpovio With Dexamethasone Approved for Refractory Multiple Myeloma
(Source: The Doctors Lounge - Oncology)
Source: The Doctors Lounge - Oncology - July 10, 2019 Category: Cancer & Oncology Tags: Oncology, Pharmacy, FDA Approvals, Source Type: news

Xpovio With Dexamethasone Approved for Refractory Multiple Myeloma
TUESDAY, July 9, 2019 -- Xpovio (selinexor) tablets have been approved for use in combination with dexamethasone to treat adults with relapsed refractory multiple myeloma, the U.S. Food and Drug Administration announced last week. The drug... (Source: Drugs.com - Daily MedNews)
Source: Drugs.com - Daily MedNews - July 10, 2019 Category: General Medicine Source Type: news

Xpovio With Dexamethasone Approved for Refractory Multiple Myeloma
TUESDAY, July 9, 2019 -- Xpovio (selinexor) tablets have been approved for use in combination with dexamethasone to treat adults with relapsed refractory multiple myeloma, the U.S. Food and Drug Administration announced last week. The drug... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - July 9, 2019 Category: Pharmaceuticals Source Type: news

FDA approves new treatment for refractory multiple myeloma
FDA grants accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other form (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 4, 2019 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Approves Selinexor for Refractory Multiple Myeloma FDA Approves Selinexor for Refractory Multiple Myeloma
Selinexor is approved in combination with the corticosteroid dexamethasone for the treatment of relapsed/refractory multiple myeloma in patients who are out of treatment options.FDA Approvals (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - July 3, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Alert Source Type: news

FDA approves new treatment for refractory multiple myeloma
Today, the U.S. Food and Drug Administration granted accelerated approval to Xpovio (selinexor) tablets in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is resistant to several other forms of treatment, (Source: World Pharma News)
Source: World Pharma News - July 3, 2019 Category: Pharmaceuticals Tags: Featured FDA Regulatory Affairs Source Type: news

FDA Approves Selinexor Combination for Refractory Multiple Myeloma
The FDA approved selinexor in combination with the corticosteroid dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - July 3, 2019 Category: Cancer & Oncology Authors: Erin Kayata Source Type: news

Dextenza (Dexamethasone Ophthalmic Insert) - updated on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - July 2, 2019 Category: Drugs & Pharmacology Source Type: news

FDA Approves Daratumumab Combination For Multiple Myeloma
The FDA approved daratumumab in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. (Source: CancerNetwork)
Source: CancerNetwork - June 28, 2019 Category: Cancer & Oncology Authors: Erin Kayata Source Type: news

Janssen Announces U.S. FDA Approval of DARZALEX ® (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible
(Source: Johnson and Johnson)
Source: Johnson and Johnson - June 27, 2019 Category: Pharmaceuticals Source Type: news

Janssen Announces FDA Approval of Darzalex (daratumumab) in Combination with Lenalidomide and Dexamethasone for Newly Diagnosed Patients with Multiple Myeloma Who Are Transplant Ineligible
HORSHAM, Pa., June 27, 2019– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the U.S. Food and Drug Administration (FDA) approval of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (Rd)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 27, 2019 Category: Drugs & Pharmacology Source Type: news

Ocular Therapeutix Announces FDA Approval of Dextenza (dexamethasone intracanalicular insert) for the Treatment of Ocular Inflammation Following Ophthalmic Surgery
BEDFORD, Mass.--(BUSINESS WIRE)--Jun. 21, 2019-- Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 24, 2019 Category: Drugs & Pharmacology Source Type: news

Long-Awaited Results of Isatuximab Combo in R/R Myeloma Presented
Researchers evaluated survival and infusion time with combination isatuximab, pomalidomide, and low-dose dexamethasone vs  pomalidomide plus low-dose dexamethasone alone in relapsed or refractory multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - June 6, 2019 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

Daratumumab + European Standard Yields Clinical Benefit in Transplant Eligible, Newly Diagnosed Myeloma
New data from the CASSIOPEIA trial evaluated the  use of daratumumab in addition to bortezomib/thalidomide/dexamethasone after ASCT in multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - June 3, 2019 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

Daratumumab Triplet for First-Line Myeloma, but Questions Remain Daratumumab Triplet for First-Line Myeloma, but Questions Remain
The daratumumab, lenalidomide, and dexamethasone triplet is a new frontline option for patients with multiple myeloma who are not candidates for transplant, but how practice-changing are the data?Medscape Medical News (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - May 29, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology News Source Type: news

Daratumumab Cuts Risk for Progression in Multiple Myeloma
WEDNESDAY, May 29, 2019 -- For patients with newly diagnosed multiple myeloma, the addition of daratumumab to lenalidomide and dexamethasone is associated with a reduced risk for disease progression or death, according to a study published in the... (Source: Drugs.com - Pharma News)
Source: Drugs.com - Pharma News - May 29, 2019 Category: Pharmaceuticals Source Type: news

Reducing Dex in Antiemetic Regimens'Makes No Sense'Reducing Dex in Antiemetic Regimens'Makes No Sense '
Mark Kris discusses the importance of dexamethasone in antiemetic regimens.Medscape Oncology (Source: Medscape Hematology-Oncology Headlines)
Source: Medscape Hematology-Oncology Headlines - April 11, 2019 Category: Cancer & Oncology Tags: Hematology-Oncology Commentary Source Type: news

CD38-Targeting Isatuximab Combo Active in Refractory Myeloma
Researchers tested the combination of isatuximab with dexamethasone and pomalidomide in patients with relapsed or refractory multiple myeloma. (Source: CancerNetwork)
Source: CancerNetwork - April 9, 2019 Category: Cancer & Oncology Authors: Leah Lawrence Source Type: news

FDA accepts second application for Ocular Therapeutix ’ s drug-delivering implant
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA has accepted a new supplemental New Drug Application for its Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The Bedford, Mass.-based company’s device is designed to deliver drugs for up to 30 days following treatment in a physician’s office. Ocular Therapeutix is positioning its product as a way to eliminate the current standard of care for post-surgical pain – topical steroid eye drops. Read the whole story on our sister site, Drug Delivery Business News (Source: Mass Device)
Source: Mass Device - April 3, 2019 Category: Medical Devices Authors: Fink Densford Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Optical/Ophthalmic Regulatory/Compliance oculartherapeutix Source Type: news

Company-led recall: Ozurdex 700 micrograms intravitreal implant in applicator (dexamethasone)
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a company-led recall for further batches of Ozurdex 700 micrograms intravitreal implant in applicator (dexamethasone) due to t (Source: Royal Pharmaceutical Society News)
Source: Royal Pharmaceutical Society News - March 19, 2019 Category: Drugs & Pharmacology Source Type: news

COPD Patients at Altitude Have Better Sleep Quality With Dexamethasone COPD Patients at Altitude Have Better Sleep Quality With Dexamethasone
Preventive dexamethasone treatment improved nocturnal oxygenation in certain chronic obstructive pulmonary disease (COPD) patients traveling to high altitudes, in a randomized controlled trial.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - March 6, 2019 Category: Consumer Health News Tags: Pulmonary Medicine News Source Type: news

dexamethasone (Decadron, DexPak)
Title: dexamethasone (Decadron, DexPak)Category: MedicationsCreated: 12/31/1997 12:00:00 AMLast Editorial Review: 3/5/2019 12:00:00 AM (Source: MedicineNet Arthritis General)
Source: MedicineNet Arthritis General - March 5, 2019 Category: Rheumatology Source Type: news

Dexamethasone Sodium Phosphate Injection (Updated - Currently in Shortage)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - February 28, 2019 Category: Drugs & Pharmacology Source Type: news

Guideline Discourages Perioperative Antibiotics, Codeine for Kids Undergoing Tonsillectomy Guideline Discourages Perioperative Antibiotics, Codeine for Kids Undergoing Tonsillectomy
Children undergoing tonsillectomy should not receive perioperative antibiotics and should not receive codeine, but they should receive a single intraoperative dose of intravenous dexamethasone, according to the 2019 updated clinical-practice guideline on tonsillectomy in children from the American Academy of Otolaryngology-Head and Neck Surgery Foundation.Reuters Health Information (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - February 12, 2019 Category: Consumer Health News Tags: Medscape Today News Source Type: news

Dexamethasone Sodium Phosphate Injection (New - Currently in Shortage)
Drug Shortage (Source: FDA Drug Shortages)
Source: FDA Drug Shortages - February 8, 2019 Category: Drugs & Pharmacology Source Type: news

Cortaren (Dexamethasone Sodium Phosphate Injection) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - January 30, 2019 Category: Drugs & Pharmacology Source Type: news

Ocular Therapeutix seeks second indication for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said yesterday that it submitted a supplement NDA to the FDA for its dexamethasone ocular insert, Dextenza. The Bedford, Mass.-based company requested that the U.S. regulatory agency expand the current indication for Dextenza to include the treatment of ocular inflammation following eye surgery. Get the full story at our sister site, Drug Delivery Business News. The post Ocular Therapeutix seeks second indication for drug-delivery eye insert appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - January 11, 2019 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Optical/Ophthalmic Pharmaceuticals Regulatory/Compliance Wall Street Beat oculartherapeutix Source Type: news

Dextenza (Dexamethasone Ophthalmic Insert) - new on RxList
(Source: RxList - New and Updated Drug Monographs)
Source: RxList - New and Updated Drug Monographs - December 14, 2018 Category: Drugs & Pharmacology Source Type: news

Daratumumab Plus Len/Dex: New Standard of Care in Myeloma? Daratumumab Plus Len/Dex: New Standard of Care in Myeloma?
Adding daratumumab to lenalidomide and dexamethasone increased progression-free survival in transplant-ineligible patients newly diagnosed with myeloma.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 6, 2018 Category: Consumer Health News Tags: Hematology-Oncology News Source Type: news

FDA Approves Dextenza (dexamethasone ophthalmic insert) for the Treatment of Ocular Pain Following Ophthalmic Surgery
BEDFORD, Mass.--(BUSINESS WIRE)--Dec. 3, 2018-- Ocular Therapeutix™, Inc. a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - December 4, 2018 Category: Drugs & Pharmacology Source Type: news

FDA OKs Steroid Insert (Dextenza) for Postop Ocular Pain FDA OKs Steroid Insert (Dextenza) for Postop Ocular Pain
Dextenza is the first FDA-approved intracanalicular insert that delivers dexamethasone to treat ocular pain following ophthalmic surgery for up to 30 days with a single insertion.FDA Approvals (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - December 3, 2018 Category: Consumer Health News Tags: Ophthalmology News Alert Source Type: news

Ocular Therapeutix wins FDA nod for drug-delivery eye insert
Ocular Therapeutix (NSDQ:OCUL) said today that the FDA approved its resubmitted application Dextenza, an ocular insert designed to release dexamethasone to relieve pain following ophthalmic surgery. The regulatory win for the Bedford, Mass.-based company comes after much back-and-forth with the FDA; the agency has twice rejected Ocular Therapeutix’s application for Dextenza. Get the full story at our sister site, Drug Delivery Business News. The post Ocular Therapeutix wins FDA nod for drug-delivery eye insert appeared first on MassDevice. (Source: Mass Device)
Source: Mass Device - December 3, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Drug-Device Combinations Food & Drug Administration (FDA) Pain Management Pharmaceuticals Regulatory/Compliance Wall Street Beat oculartherapeutix Source Type: news