Drug News

Added 17 hours ago Drug news

FDA approves Otelza for the treatment of oral ulcers associated with Behçet’s disease.

Celgene Corporation announced that the FDA has approved Otezla (apremilast) 30 mg twice daily (BID) for the treatment of adult...

Added 17 hours ago Drug news

Interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine evaluating MultiTAA T cell therapy in patients with pancreatic adenocarcinoma.- Marker Therapeutics

Marker Therapeutics, Inc. announced interim data from an ongoing investigator-sponsored clinical trial led by Baylor College of Medicine , evaluating...

Added 1 day ago Drug news

FDA 510(k) clearance for LifeSPARC system advanced circulatory support (ACS) pump.- LivaNova PLC

LivaNova PLC announced it has received 510(k) clearance from the FDA for its new Advanced Circulatory Support (ACS) pump and...

Added 1 day ago Drug news

CE Mark for ProFound AI for 2D mammography software system to analyze 2D mammography scans . ICAD

ICAD, has secured European CE Mark approval for its ProFound AI for 2D Mammography software system. The product relies on...

Added 1 day ago Drug news

Alkermes to expand the proposed NDA for ALKS 3831 to include bipolar 1 disorder as well as schizophrenia .

Alkermes provided an update on its regulatory strategy for ALKS 3831 (olanzapine/samidorphan), the company's investigational, novel, once-daily, oral atypical antipsychotic...

Added 1 day ago Drug news

Janssen Biotech applied to EMA for extension of the Darzalex marketing authorization for subcutaneous formulation in multiple myeloma indications.

Genmab A/S announced that its licensing partner, Janssen Biotech, Inc., has submitted an application for the extension of the Darzalex...

Added 2 days ago Drug news

FDA grants 510(k) clearance for FX 635 laser device in chronic musculoskeletal pain.- Erchonia

Erchonia Corp announced that the FDA has granted the company 510(k) clearance to market its FX 635 low level laser...

Added 2 days ago Drug news

FDA accepts NDA to make Procysbi available as oral granules in packets to treat nephropathic cystinosis.- Horizon Therapeutics

Horizon Therapeutics plc announced that the FDA has accepted Horizon’s New Drug Application (NDA) for Procysbi (Cysteamine Bitartrate) Delayed-Release Oral...

Added 3 days ago Drug news

Mvasi biosimilar to Avastin and Kanjinti biosimilar to Herceptin are launched in US. Amgen + Allergan

Amgen and Allergan plc announced that Mvasi (bevacizumab-awwb), a biosimilar to Avastin (bevacizumab), and Kanjinti (trastuzumab-anns), a biosimilar to Herceptin...

Added 2 days ago Drug news

LivaNova launches Bi-Flow to prevent limb ischemia during cardiac surgery.

LivaNova PLC launched its innovative arterial femoral cannula, Bi-Flow, designed to prevent limb ischemia during cardiac surgery. LivaNova Bi-Flow received...

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