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FDA Approves Xhance

Clinical Approvaldrugs2017-09-21 09:34Read   0

Optinose Announces FDA Approval of Xhance (fluticasone propionate) Nasal Spray for the Treatment of Nasal Polyps.

FDA Approves Trelegy Ellipta

New Combinationdrugs2017-09-21 09:34Read   0

FDA Approves Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for the Treatment of COPD

FDA Approves Solosec

Indicationdrugs2017-09-19 13:37Read   2

ymbiomix Therapeutics today announced the U.S. Food and Drug Administration (FDA) has approved Solosec (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec is a potent, next-generation, 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties that enable delivery in a single dose that’s been shown to be efficacious and well tolerated. Solosec is the first and only single-dose oral therapy for BV, the most common gynecologic infection in the U.S.

FDA Approves Adzenys ER

Expansiondrugs2017-09-19 13:37Read   2

Neos Therapeutics, Inc. (Nasdaq:NEOS), a pharmaceutical company focused on developing, manufacturing and commercializing innovative extended-release products using its proprietary modified-release drug delivery technologies, today announced that the U.S. Food and Drug Administration (FDA) has approved Adzenys ER™ (amphetamine) Extended-Release Oral Suspension. Neos Therapeutics is the only company to offer both branded amphetamine and methylphenidate products in extended-release dosage forms.

FDA Approves Trelegy Ellipta

Indicationdrugs2017-09-19 13:37Read   2

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. (NASDAQ: INVA) today announced that the US Food and Drug Administration (FDA) has approved once-daily, single inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), under the brand name Trelegy Ellipta, for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are on a fixed-dose combination of fluticasone furoate and vilanterol for airflow obstruction and reducing exacerbations in whom additional treatment of airflow obstruction is desired or for patients who are already receiving umeclidinium and a fixed-dose combination of fluticasone furoate and vilanterol. Trelegy Ellipta is not indicated for relief of acute bronchospasm or the treatment of asthma.

FDA Approves Aliqopa

sNDAdrugs2017-09-15 11:45Read   3

FDA Approves Aliqopa (copanlisib) for Adults with Relapsed Follicular Lymphoma

FDA Approves Mvasi

Genericdrugs2017-09-15 11:45Read   5

FDA Approves Mvasi (bevacizumab-awwb), a Biosimilar to Avastin

FDA Approves Mylotarg

sNDAFDA2017-09-04 08:54Read   10

FDA Approves Mylotarg (gemtuzumab ozogamicin) for the Treatment of Acute Myeloid Leukemia

FDA Approves Genentech’s Actemra (tocilizumab) for the Treatment of CAR T Cell-Induced Cytokine Release Syndrome

sNDAGenetech2017-09-04 08:44Read   12

Genentech announced today that the U.S. Food and Drug Administration (FDA) has approved Actemra® (tocilizumab) intravenous injection for the treatment of chimeric antigen receptor (CAR) T cell-induced severe or life-threatening cytokine release syndrome (CRS) in patients two years of age and older. CRS, which is caused by an overactive immune response, has been identified as a potentially severe and life-threatening side effect of CAR T cell therapy for certain cancers.1

FDA approves first U.S. treatment for Chagas disease

sNDAFDA2017-08-31 09:00Read   13

The U.S. Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the United States for the treatment of Chagas disease.

FDA approves new antibacterial drug

sNDAFDA2017-08-31 08:56Read   16

The U.S. Food and Drug Administration today approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

FDA Approves the first CAR-T treatment--Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia

sNDAFDA2017-08-31 08:54Read   13

FDA Approves Kymriah (tisagenlecleucel) CAR-T Gene Therapy for Acute Lymphoblastic Leukemia

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