FDA approves use of XELJANZ on children
The U.S. Food and Drug Administration (FDA) recently approved Pfizer’s drug XELJANZ (tofacitinib) for treatment of polyarticular course juvenile idiopathic arthritis (pcJIA). Read More »
The U.S. Food and Drug Administration (FDA) recently approved Pfizer’s drug XELJANZ (tofacitinib) for treatment of polyarticular course juvenile idiopathic arthritis (pcJIA). Read More »
Thousands of Americans suffer from Chronic Obstructive Pulmonary Disease (COPD), but new recommendations from a pair of health organizations may help ease their discomfort. Read More »
American Regent announces the introduction and availability of Estradiol Valerate Injection, USP – AO Rated and therapeutically equivalent to Delestrogen®1,2. Read More »
Nearly 90 percent survival for patients who received REGN-EB3 treatment earlier in the course of their disease; 66.5 percent survival among all patients who received REGN-EB3 Read More »
Court rules in favor of Regeneron and Sanofi in ongoing Praluent® (alirocumab) patent litigation Read More »
Altaire Pharmaceuticals, Inc., announces today that it is voluntarily recalling the Veterinary ophthalmic drug products and lots, within expiry, identified below. This recall is only for the specific lots listed. No other lots are being recalled. Read More »
American Regent today announced the introduction of Selenious Acid Injection, USP. Read More »
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Dupixent® (dupilumab), recommending to extend its approval in the European Union (EU) to include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Read More »
93% overall response (13 of 14 patients) and 71% complete response rates (10 of 14 patients) in follicular lymphoma grades 1 to 3a treated with REGN1979 5 mg to 320 mg Read More »
Synergy Pharmaceuticals Inc. (NASDAQ: SGYP) (the "Company" or "Synergy"), a biopharmaceutical company focused on the development and commercialization of novel gastrointestinal (GI) therapies, today confirmed that the previously announced sale of certain assets to Bausch Health Companies Inc. is now complete. Read More »
Accomplished Medical Physicist will drive relevant activities related to Antibody Radiation Conjugates for targeted conditioning, therapeutic combinations, and AWE technology platform development Read More »
First and Only FDA-Approved Inhaled Levodopa for Intermittent Treatment of OFF Episodes in People with Parkinson’s Taking Carbidopa/Levodopa Read More »
LORBRENA Addresses Unmet Needs for Certain Patients Treated With Prior ALK Therapy Read More »
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) of EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy (DR), the leading cause of vision loss for patients with diabetes. Read More »
Novartis announced today that the European Commission (EC) has approved Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) for the adjuvant treatment of stage III patients with BRAF V600 mutation-positive melanoma after complete surgical resection. Read More »
Regeneron Pharmaceuticals, Inc. (NASDAQ : REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for EYLEA® (aflibercept) Injection in patients with wet age-related macular degeneration (wet AMD). Read More »
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) for the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Read More »
Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. Read More »
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended expanded approval of the current indications for Opdivo (nivolumab) to include the adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. Read More »
Pfizer Inc. (NYSE:PFE) today announced that the U.S.Food and Drug Administration (FDA) accepted the company’s New Drug Application and granted Priority Review designation for glasdegib, an investigational oral smoothened (SMO) inhibitor, being evaluated for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy. Read More »