Drug News

Added 4 hours ago Drug news

FDA expands Revlimid (lenalidomide) indication to include use for patients with multiple myeloma as maintenance therapy following autologous hematopoietic stem cell transplant.-Celgene

Celgene Corporation announced that the FDA has expanded the existing indication for Revlimid (lenalidomide) 10 mg capsules to include use...

Added 1 day ago Drug news

FDA accepts resubmission (NDA) of Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery.-Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. announced that the Company’s New Drug Application (NDA) resubmission for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular...

Added 1 day ago Drug news

EU approves change to authorisation for Repatha (evolocumab) to approve single-dose delivery option in dyslipidaemia treatment- Amgen

Amgen announced that the European Commission (EC) has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a...

Added 1 day ago Drug news

European Commission approves Olumiant (baricitinib) to treat moderate-to-severe active rheumatoid arthritis.- Eli Lilly and Company and Incyte Corporation.

Eli Lilly and Company and Incyte Corporation announced that the European Commission has granted marketing authorisation for Olumiant (baricitinib) 4...

Added 1 day ago Drug news

NICE confirms positive guidance on use of Galafold (migalastat) to treat Fabry disease.- Amicus Therapeutics

The National Institute for Health and Care Excellence (NICE) has confirmed final guidance endorsing the use of Galafold (migalastat) from...

Added 2 days ago Drug news

Data review of Phase III study of Macrilen (macimorelin) for the evaluation of growth hormone deficiency in adults. -Aeterna Zentaris Inc.

Aeterna Zentaris Inc. announced that, following a comprehensive review of data obtained from the confirmatory Phase III clinical trial of...

Added 5 days ago Drug news

Tivantinib fails to meet endpoint in METIV-HCC Phase III trial for hepatocellular carcinoma.- ArQule Inc. + Daiichi Sankyo

ArQule, Inc.and Daiichi Sankyo announced that the METIV-HCC phase III study of tivantinib in hepatocellular carcinoma (HCC) did not meet...

Added 5 days ago Drug news

Phase III trial of Inflectra (infliximab CT-P13) meets endpoint in Crohn’s disease- Pfizer and Celltrion Healthcare

Data announced by Pfizer and Celltrion Healthcare showed that for patients with moderate-to-severe Crohn’s disease (CD), treatment with Inflectra (infliximab...

Added 6 days ago Drug news

Long-term extension study of Stelara (ustekinumab) in adults with Crohn's disease shows response maintained for up to 2 years- Janssen Biotech

Janssen Biotech announced new two-year data from the ongoing IM-UNITI long-term extension (LTE) study evaluating the efficacy and safety of...

Added 6 days ago Drug news

Phase III ADMIRE-CD clinical trial of Cx 601 (adipose-derived stem cells) shows long term remission in Crohn's disease- Takeda/TiGenix

Takeda Pharmaceutical Company and TiGenix announced new data from the Phase III ADMIRE-CD clinical trial, which indicated that Cx 601,...

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