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sNDAFDA2017-07-18 09:13Read   3

FDA Approves Nerlynx (neratinib) for Extended Adjuvant Treatment of Early Stage HER2-Positive Breast Cancer

FDA Approves Tremfya

sNDAJanssen2017-07-17 09:13Read   8

Janssen Announces FDA Approval of Tremfya (guselkumab) for the Treatment of Moderate to Severe Plaque Psoriasis

FDA Grants Full Approval for Blincyto

BLA ApprovalAmgen2017-07-13 08:38Read   2

FDA Grants Full Approval for Blincyto (blinatumomab) to Treat Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia in Adults and Children

Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis

sNDAEMA2017-07-11 08:27Read   6

Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) has approved a label update for Cosentyx® (secukinumab), the first interleukin-17A (IL-17A) approved to treat psoriasis.

FDA Approves Vectibix® (Panitumumab) For Use In Wild-Type RAS Metastatic Colorectal Cancer

sNDAAmgen2017-07-11 08:27Read   7

Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Vectibix® (panitumumab) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer (mCRC) as first-line therapy in combination with FOLFOX and as monotherapy following disease progression after prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-containing chemotherapy.

FDA Approves Endari

sNDAFDA2017-07-10 08:30Read   8

FDA Approves Endari (L-glutamine oral powder) for Sickle Cell Disease

FDA Approves Orencia for Psoriatic Arthritis

sNDABMY2017-07-10 08:29Read   9

Bristol-Myers Squibb’s Orencia (abatacept) Receives FDA Approval for Treatment of Active Psoriatic Arthritis in Adults

FDA Approves Triptodur

sNDAarborpharma2017-07-03 08:37Read   5

Arbor Pharmaceuticals, LLC Announces FDA Approval for Triptodur (triptorelin)

EMA approved Fotivda

sNDAEMA2017-06-29 08:48Read   9

CHMP adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Fotivda, intended for the treatment of advanced renal cell carcinoma. The applicant for this medicinal product is EUSA Pharma.

Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept) to treat multiple inflammatory diseases

sNDANovartis2017-06-28 08:41Read   7

Sandoz announced today that the European Commission (EC) has approved Erelzi® (biosimilar etanercept) for use in Europe

Ribociclib receives positive CHMP opinion as first-line treatment for HR /HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor

CombinationEMA2017-06-27 08:41Read   11

The European Medicines Agency (EMA) has approved ribociclib in combination with an aromatase inhibitor for treatment of postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR /HER2-) locally advanced or metastatic breast cancer as initial endocrine-based therapy.

FDA Approves Haegarda

sNDAFDA2017-06-26 08:42Read   8

FDA Approves Haegarda - First Subcutaneous C1 Esterase Inhibitor for Hereditary Angioedema

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