sNDAFDA2018-03-07 09:03Read 25
The U.S. Food and Drug Administration approved Trogarzo (ibalizumab-uiyk), a new type of antiretroviral medication for adult patients living with HIV who have tried multiple HIV medications in the past (heavily treatment-experienced) and whose HIV infections cannot be successfully treated with other currently available therapies (multidrug resistant HIV, or MDR HIV).
CombinationFDA2018-02-11 08:57Read 32
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).
sNDAAllergan plc 2018-02-05 08:50Read 24
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.
sNDACutisPharma2018-02-01 08:44Read 42
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.
sNDAFDA2018-01-30 10:43Read 19
FDA Approves Lutathera (lutetium Lu 177 dotatate) for Gastroenteropancreatic Neuroendocrine Tumors
IndicationBristol-Myers Squibb2018-01-29 08:59Read 19
Yervoy is the first and only Immuno-Oncology agent to receive approval in the European Union in this patient population
IndicationBoehringer Ingelheim2018-01-18 08:36Read 35
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.