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FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

CombinationFDA2018-02-11 08:57Read   4

On February 7, 2018, the Food and Drug Administration (FDA) approved abiraterone acetate tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC).

FDA Approves Biktarvy

sNDAGilead Sciences2018-02-08 09:11Read   6

FDA Approves Biktarvy (bictegravir, emtricitabine, tenofovir alafenamide) for Treatment of HIV-1 Infection

FDA Approves Avycaz (ceftazidime and avibactam) for the Treatment of Patients with Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia

sNDAAllergan plc 2018-02-05 08:50Read   6

Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Allergan's supplemental New Drug Application (sNDA) to expand the approved use of Avycaz (ceftazidime and avibactam) to include the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by the following susceptible Gram-negative microorganisms: Klebsiella pneumoniae, Enterobacter cloacae, Escherichia coli, Serratia marcescens, Proteus mirabilis, Pseudomonas aeruginosa, and Haemophilus influenzae in patients 18 years of age or older.

CutisPharma Announces FDA Approval of Firvanq (vancomycin) for Treatment of Clostridium Difficile Associated Diarrhea and Staphylococcus Aureus Colitis

sNDACutisPharma2018-02-01 08:44Read   5

CutisPharma announced today that the US Food and Drug Administration (FDA) has approved Firvanq (vancomycin hydrochloride) for oral solution, for the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains.

FDA approves new treatment for certain digestive tract cancers

sNDAFDA2018-01-30 10:43Read   4

FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors

European Commission Approves Bristol-Myers Squibb’s Yervoy (ipilimumab) for Treatment of Pediatric Patients 12 Years and Older with Unresectable or Metastatic Melanoma

IndicationBristol-Myers Squibb2018-01-29 08:59Read   0

Yervoy is the first and only Immuno-Oncology agent to receive approval in the European Union in this patient population

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

IndicationBoehringer Ingelheim2018-01-18 08:36Read   16

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 with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.

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

sNDAFDA2018-01-15 09:17Read   12

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 specific inherited (germline) genetic mutation, making it the first drug in its class (PARP inhibitor) approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.

FDA approves denosumab for the prevention of skeletal events In multiple myeloma patients

BLA ApprovalAmgen2018-01-08 08:55Read   15

The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for denosumab to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumours to include patients with multiple myeloma.

Merck’s KEYTRUDA® (pembrolizumab) Approved in Japan for Use in the Treatment of Patients with Urothelial Carcinoma That is Unresectable with Radical Surgery Who Have Progressed Following Cancer Chemotherapy

sNDAMerck2018-01-03 17:28Read   16

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy.

FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss

sNDAFDA2017-12-21 09:25Read   19

Luxturna is the first directly administered gene therapy approved in the U.S. that targets a disease caused by mutations in a specific gene.

FDA Approves Eskata

sNDAAclaris Therapeutics2017-12-18 09:04Read   21

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

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