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Added 4 hours ago Drug news

Anixa Biosciences has filed an IVD pre-submission with the FDA for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test.

Anixa Biosciences formerly ITUS Corporation , a biotechnology company focusing on cancer diagnostics for all cancers and CAR-T cell immunotherapy...

Added 4 hours ago Drug news

Phase III SAkuraSky Study shows SA 237 cuts risk of relapse in neuromyelitis optica.- Chugai Pharma.

Chugai Pharmaceutical announced new results from the phase III study of SA 237 (satralizumab) SAkuraSky Study (NCT02028884) for the treatment...

Added 4 hours ago Drug news

FDA approves Yutiq for chronic non-infectious uveitis.- EyePoint Pharma.

EyePoint Pharmaceuticals announced that the FDA has approved Yutiq (fluocinolone acetonide intravitreal implant) for the treatment of chronic non-infectious uveitis...

Added 4 hours ago Drug news

FDA approves Xarelto to reduce the risk of CV events.- Bayer Healthcare + Janssen

The FDA has approved rivaroxaban (Xarelto), 2.5 mg twice daily, plus aspirin low dose once daily to reduce the risk...

Added 4 hours ago Drug news

The FDA has agreed to a rolling submission for givosiran for acute hepatic porphyria.- Alnylam Pharma

Alnylam Pharmaceuticals, Inc.has announced that in consultation with the FDA, the Company plans to pursue a full approval based on...

Added 4 hours ago Drug news

Phase III KATHERINE study of Kadcyla meets primary endpoint in HER2+ breast cancer.- Genentech/Roche.

Genentech/Roche announced the Phase III KATHERINE study met its primary endpoint, showing Kadcyla (ado-trastuzumab emtansine) as a single agent significantly...

Added 1 day ago Drug news

For children and adolescents with type 1 diabetes, Fiasp could be an option to better manage their blood sugar levels.- Novo Nordisk

For children and adolescents (1 to less then 18 years old) living with type 1 diabetes, Fiasp (an ultra-fast acting...

Added 4 hours ago Drug news

European Commission approves Hulio (adalimumab biosimilar)for all indications of the reference drug.- Mylan + Fujifilm Kyowa Kirin Biologics.

The European commission (EC) has granted marketing authorization to Mylan and Fujifilm Kyowa Kirin Biologics for Hulio, a biosimilar to...

Added 2 days ago Drug news

FDA Advisory Committee negative for oliceridine to treat moderate to severe acute pain.- Trevena Inc.

Trevena, Inc. announced the outcome of the meeting of the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to...

Added 2 days ago Drug news

FDA Advisory Committee recommends approval of Dsuvia to treat moderate-to-severe acute pain.- AcelRx Pharmaceuticals

AcelRx Pharmaceuticals, Inc. announced that the Anesthetic and Analgesic Drug Products Advisory Committee of the FDA voted 10-3 in favor...

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