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FDA approves another home genetic testing service

sNDAFDA2018-03-19 08:20Read   28

23andMe’s kit will check for an increased risk of certain cancers developing

FDA approves new HIV treatment for patients who have limited treatment options

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).

FDA Approves Apadaz

sNDAKemPharm2018-02-27 08:46Read   30

FDA Approves Apadaz (benzhydrocodone and acetaminophen) for the Short-Term Management of Acute Pain

FDA Approves Symdeko

sNDAVertex Pharmaceuticals2018-02-26 09:06Read   30

FDA Approves Symdeko (tezacaftor/ivacaftor and ivacaftor) to Treat Cystic Fibrosis in People Ages 12 and Older with Certain Mutations in the CFTR Gene

FDA Approves Erleada

sNDAFDA2018-02-26 09:04Read   25

FDA Approves Erleada (apalutamide) for Non-Metastatic Castration-Resistant Prostate Cancer

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

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).

FDA Approves Biktarvy

sNDAGilead Sciences2018-02-08 09:11Read   40

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   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.

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

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.

FDA approves new treatment for certain digestive tract cancers

sNDAFDA2018-01-30 10:43Read   19

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   19

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   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.

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