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Drugs.com - New Drug Approvals



New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.



 



FDA Approves New Indication for Gilotrif (afatinib) in EGFR Mutation-Positive NSCLC

Tue, 16 Jan 2018 04:01:55 GMT

Ridgefield, Conn., January 16, 2018 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Gilotrif (afatinib) for the first-line treatment of patients...



FDA Approves Lynparza (olaparib tablets) for Germline BRCA-Mutated Metastatic Breast Cancer

Fri, 12 Jan 2018 21:01:32 GMT

January 12, 2018 -- The U.S. Food and Drug Administration today expanded the approved use of Lynparza (olaparib tablets) to include the treatment of patients with certain types of breast cancer that have spread (metastasized) and whose tumors have a...



GSK Receives FDA Approval for Expanded Indication for Fluarix Quadrivalent (Influenza Vaccine) for Persons 6 Months and Older

Thu, 11 Jan 2018 04:01:30 GMT

Philadelphia, PA, January 11, 2018 -- GSK [LSE/NYSE: GSK] announced today it has received approval from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research expanding the indication for Fluarix Quadrivalent...



FDA Approves Xgeva (denosumab) for the Prevention of Skeletal-Related Events in Patients with Multiple Myeloma

Fri, 05 Jan 2018 01:01:40 GMT

THOUSAND OAKS, Calif., Jan. 5, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Xgeva (denosumab) to expand the currently...



Bausch + Lomb Receives FDA Approval of Lumify (brimonidine tartrate) Over-the-Counter Eye Drop for the Treatment of Eye Redness

Fri, 22 Dec 2017 23:12:36 GMT

LAVAL, Quebec, Dec. 22, 2017 /PRNewswire/ -- Bausch + Lomb, a leading global eye health company and wholly owned subsidiary of Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) ("Valeant"), today announced that the U.S. Food and...



FDA Approves Segluromet (ertugliflozin and metformin hydrochloride) for Type 2 Diabetes

Fri, 22 Dec 2017 23:12:23 GMT

KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved...



FDA Approves Steglujan (ertugliflozin and sitagliptin) for Type 2 Diabetes

Fri, 22 Dec 2017 23:12:18 GMT

KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE) December 22, 2017 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved...



FDA Approves Steglatro (ertugliflozin) for Type 2 Diabetes

Fri, 22 Dec 2017 23:12:01 GMT

KENILWORTH, N.J. & NEW YORK--(BUSINESS WIRE) December 22, 2017 -- Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Pfizer Inc. (NYSE:PFE), today announced that the U.S. Food and Drug Administration (FDA) has approved...



FDA Updates the Label of Tasigna to Reflect that Certain Patients with a Type of Leukemia May be Eligible to Stop Treatment After Sustained Response

Fri, 22 Dec 2017 05:12:29 GMT

December 22, 2017 -- The U.S. Food and Drug Administration today updated the product label for the cancer drug Tasigna (nilotinib) to include information for providers about how to discontinue the drug in certain patients. Tasigna, first approved by...



FDA Approves Giapreza (angiotensin II) to Treat Dangerously Low Blood Pressure

Thu, 21 Dec 2017 21:12:55 GMT

December 21, 2017 -- The U.S. Food and Drug Administration today approved Giapreza (angiotensin II) injection for intravenous infusion to increase blood pressure in adults with septic or other distributive shock. "Shock, the inability to maintain...



Aeterna Zentaris Announces FDA Approval of Macrilen (macimorelin) for Diagnosis of Adult Growth Hormone Deficiency

Wed, 20 Dec 2017 22:12:29 GMT

CHARLESTON, S.C. December 20, 2017 -- Aeterna Zentaris Inc. (NASDAQ and TSX: AEZS), a specialty biopharmaceutical company engaged in developing and commercializing pharmaceutical therapies, announced today that the U.S. Food and Drug Administration...



FDA Approves Genentech’s Perjeta (Pertuzumab) for Adjuvant Treatment of Specific Type of Early Breast Cancer

Wed, 20 Dec 2017 05:12:46 GMT

South San Francisco, CA -- December 20, 2017 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced the U.S. Food and Drug Administration (FDA) has approved Perjeta ® (pertuzumab), in combination with Herceptin®...



Bristol-Myers Squibb Receives FDA Approval for Opdivo (nivolumab) as Adjuvant Therapy in Patients with Completely Resected Melanoma with Lymph Node Involvement or Metastatic Disease

Wed, 20 Dec 2017 05:12:28 GMT

PRINCETON, N.J.--(BUSINESS WIRE)-- December 20, 2017 Bristol-Myers Squibb Company (NYSE:BMY) announced today that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the adjuvant treatment of...



FDA Approves Pfizer’s Bosulif (bosutinib) for the Treatment of Patients with Newly-Diagnosed Ph+ Chronic Myelogenous Leukemia (CML)

Tue, 19 Dec 2017 21:12:26 GMT

December 19, 2017 -- Pfizer Inc. (NYSE:PFE) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with...



Exelixis Announces U.S. FDA Approval of Cabometyx (cabozantinib) Tablets for Previously Untreated Advanced Renal Cell Carcinoma

Tue, 19 Dec 2017 21:12:24 GMT

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Dec. 19, 2017-- Exelixis, Inc. (NASDAQ:EXEL) today announced that the U.S. Food and Drug Administration (FDA) approved Cabometyx (cabozantinib) tablets for the expanded indication of patients with...



FDA Approves Luxturna (voretigene neparvovec-rzyl) Gene Therapy to Treat Patients with a Rare Form of Inherited Vision Loss

Tue, 19 Dec 2017 21:12:17 GMT

December 19, 2017 -- The U.S. Food and Drug Administration today approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. Luxturna is...



Aerie Pharmaceuticals Announces U.S. FDA Approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for Patients with Open-Angle Glaucoma or Ocular Hypertension

Tue, 19 Dec 2017 21:12:12 GMT

IRVINE, Calif.--(BUSINESS WIRE)--Dec. 18, 2017-- Aerie Pharmaceuticals, Inc. (NASDAQ:AERI) (Aerie or the Company), an ophthalmic pharmaceutical company focused on the discovery, development, and commercialization of first-in-class therapies for the...



Medicure Announces FDA Approval Received for Prexxartan (valsartan) Oral Solution

Tue, 19 Dec 2017 04:12:09 GMT

WINNIPEG, Dec. 19, 2017 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a pharmaceutical company, today announced that Carmel Biosciences, Inc. ("Carmel") has received final approval of its New Drug Application from...



Aclaris Therapeutics Receives FDA Approval for Eskata (hydrogen peroxide) Topical Solution, 40% (w/w) for the Treatment of Raised Seborrheic Keratoses

Sun, 17 Dec 2017 23:12:17 GMT

MALVERN, Pa., Dec. 15, 2017 (GLOBE NEWSWIRE) -- Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Eskata (hydrogen peroxide) topical...



Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream 1%, a Novel Topical Antibiotic for Impetigo

Thu, 14 Dec 2017 21:12:51 GMT

FAIRFIELD, N.J., Dec. 14, 2017 /PRNewswire/ -- Medimetriks Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Xepi (ozenoxacin) Cream, 1%, a new chemical entity for the treatment of impetigo in patients...