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Novartis' orphan drug Tasigna wins EU expanded indication

IndicationNovartis2017-11-23 08:53Read   0

The CML medication can now treat paediatric patients

First Herceptin biosimilar cleared in Europe

BLA ApprovalSamsung Bioepis2017-11-23 08:45Read   0

Ontruzant is approved for all the same indications as Roche’s blockbuster

FDA Approves Juluca

CombinationFDA 2017-11-23 08:41Read   0

FDA Approves Juluca (dolutegravir and rilpivirine) for the Maintenance Treatment of Virologically Suppressed HIV-1 Infection

EMA approves GSK’s triple COPD therapy

CombinationGSK2017-11-20 08:33Read   3

Trelegy can now be marketed as a maintenance treatment in Europe

FDA Approves Hemlibra

sNDAFDA2017-11-17 08:47Read   5

FDA Approves Hemlibra (emicizumab-kxwh) for Hemophilia A with Inhibitors

NHS approval of palbociclib and ribociclib to treat advanced breast cancer

Combinationnice.org.uk2017-11-16 08:31Read   5

Palbociclib and ribociclib have received approval by NICE for the treatment for women with previously untreatable advanced breast cancer.

Boehringer claims EU okay for Humira biosimilar

ExpansionBoehringer2017-11-15 09:53Read   1

Boehringer Ingelheim has picked up its first EU approval for a biosimilar drug, getting a green light from the EMA for its version of AbbVie’s blockbuster immunotherapy Humira.

First digital medicine approved in the US

medical appliancesFDA2017-11-15 09:53Read   3

Offering both the promise of better patient compliance with health care, but also fears of a medical "Big Brother," a newly approved "digital pill" allows physicians to track whether or not it's been ingested by patients.

FDA Approves Prevymis

Clinical ApprovalMerck2017-11-13 08:33Read   9

FDA Approves Prevymis (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients

Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients

sNDAMerck2017-11-10 08:34Read   12

CMV Prophylaxis with PREVYMIS Associated with Lower All-Cause Mortality Through Week 24 and Week 48 Post-Transplant

FDA approves alectinib as first-line treatment for ALK positive NSCLC

IndicationFDA & BusinessWire2017-11-08 08:15Read   7

The U.S. Food and Drug Administration has granted regular approval to alectinib (ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test.

FDA Approves Zelboraf (vemurafenib) for Erdheim-Chester Disease with BRAF V600 Mutation

sNDAFDA2017-11-07 08:38Read   11

The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD.

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