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FDA approves new treatment for advanced pancreatic cancer

IndicationFDA2015-10-23 09:23 Read   257

The U.S. Food and Drug Administration approved Onivyde (irinotecan liposome injection), in combination with fluorouracil and leucovorin, to treat patients with advanced (metastatic) pancreatic cancer who have been previously treated with gemcitabine-based chemotherapy.

FDA approves first Factor X concentrate to treat patients with rare hereditary bleeding disorder

BLA ApprovalFDA2015-10-22 15:37 Read   457

The U.S. Food and Drug Administration today approved Coagadex, Coagulation Factor X (Human), for hereditary Factor X (10) deficiency. Until today’s orphan drug approval, no specific coagulation factor replacement therapy was available for patients with hereditary Factor X deficiency.

FDA approves new drug to treat hyperkalemia

NCE ApprovalFDA2015-10-22 15:24 Read   355

 Oct 21, 2015 | The U.S. Food and Drug Administration approved Veltassa (patiromer for oral suspension) to treat hyperkalemia, a serious condition in which the amount of potassium in the blood is too high.

Gammaplex® Approved For Use In Pediatric Patients

Pediatric ApprovalBPL2015-10-21 13:46 Read   193

Gammaplex [Immune Globulin Intravenous (Human) 5% Liquid] Approved in Patients  2 years and Older with Primary Immunodeficiencies

Basilea announces that European Commission approves isavuconazole (CRESEMBA®) as a treatment for invasive aspergillosis and mucormycosis in the European Union

MarketPharmacodia.com2015-10-18 00:00 Read   284

October 16, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that the European Commission has approved the antifungal isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.

FDA approves Praxbind, the first reversal agent for the anticoagulant Pradaxa

BLA ApprovalPharmacodia.com2015-10-17 00:00 Read   959

The U.S. Food and Drug Administration today granted accelerated approval to Praxbind (idarucizumab) for use in patients who are taking the anticoagulant Pradaxa (dabigatran) during emergency situations when there is a need to reverse Pradaxa’s blood-thinning effects.

FDA expands approved use of Opdivo in advanced lung cancer

IndicationPharmacodia.com2015-10-10 00:00 Read   325

The U.S. Food and Drug Administration approved Opdivo (nivolumab) to treat patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy, Oct 9, 2015.

FDA approves new injectable drug to treat schizophrenia

NCE ApprovalPharmacodia.com2015-10-07 00:00 Read   626

On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to treat adults with schizophrenia. Aristada is administered by a health care professional every four to six weeks using an injection in the arm or buttocks.

FDA Approves KEYTRUDA® (pembrolizumab) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer Whose Tumors Express PD-L1 with Disease Progression On or After Platinum-Containing Chemotherapy

IndicationPharmacodia.com2015-10-04 00:00 Read   1214

The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA (pembrolizumab) monotherapy, the company’s anti-PD-1 (programmed death receptor-1) therapy, at a dose of 2 mg/kg every three weeks, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

U.S. Food and Drug Administration Approves New Treatment Combination of Gilead’s Letairis® with Tadalafil for Pulmonary Arterial Hypertension (WHO Group 1)

CombinationPharmacodia.com2015-10-04 00:00 Read   616

First-Line Combination of Letairis and Tadalafil Reduced Risk of Disease Progression by Nearly 50 Percent Compared to Either Therapy Individually in Study of 605 PAH Patients with WHO Functional Class II-III Symptoms.

Bristol-Myers Squibb Receives Approval from the U.S. Food and Drug Administration for the Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen in BRAF V600 Wild-Type Unresectable or Metastatic Melanoma

CombinationPharmacodia.com2015-10-02 00:00 Read   945

USA October 1, 2015, Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab), for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. Today’s announcement marks the first and only FDA approval of a Regimen of two Immuno-Oncology agents in cancer. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

MARIZEV® (Omarigliptin), Merck's Once-Weekly DPP-4 Inhibitor for Type 2 Diabetes, Approved in Japan

NCE ApprovalPharmacodia.com2015-09-29 00:00 Read   1204

Merck, known as MSD outside the United States and Canada, in Sep 28, announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved MARIZEV(omarigliptin) 25 mg and 12.5 mg tablets, an oral, once-weekly DPP-4 inhibitor indicated for the treatment of adults with type 2 diabetes. Japan is the first country to have approved omarigliptin.