Drug News

Added 4 days ago Drug news

Completion of interim statistical assessment and small increase in target enrollment for KALM-2 phase III trial of Korsuva injection in hemodialysis patients with pruritus.- Cara Therapeutics

Cara Therapeutics, Inc. announced the completion of an interim statistical assessment of its pivotal KALM-2 Phase III global clinical trial...

Added 16 hours ago Drug news

CHMP recommends Baqsimi, the first treatment for severe hypoglycaemia administered without an injection to patients with diabetes aged four years and older.- Eli Lilly

EMA’s human medicines committee (CHMP) has recommended granting a marketing authorisation in the European Union for Baqsimi (glucagon), from Eli...

Added 16 hours ago Drug news

Herzuma and Truxima biosimilars to be distributed in Australia by Celltrion and to hospitals by Juno Pharmaceuticals.

Celltrion Healthcare (Celltrion) has entered into a partnership with Juno Pharmaceuticals (Juno) ( not to be confused with Juno Therapeutics)...

Added 16 hours ago Drug news

Submission to EMA for Nuzyra in ABSSSI and CABP withdrawn.- Paratek Pharma

Paratek Pharmaceuticals announced that the company has withdrawn its submission to the European Medicines Agency (EMA) of the Marketing Authorization...

Added 16 hours ago Drug news

CHMP recommends approval of Keytruda in head and neck squamous cell carcinoma.- Merck Inc.

Merck announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a...

Added 16 hours ago Drug news

510(k) approval for low-profile enteral feeding device (PEG) from Fidmi Medical Ltd.

Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd., received 510(k) regulatory clearance from the FDA for its...

Added 16 hours ago Drug news

CHMP does not recommend approval of quizartinib for use in acute myeloid leukemia.- Daiichi Sankyo

Daiichi Sankyo announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted...

Added 16 hours ago Drug news

Evenity receives positive CHMP opinion for treatment of severe osteoporosis in postmenopausal women at high risk of fracture. Amgen + UCB

Amgen and UCB announced that following a re-examination procedure, the Committee for Medicinal Products for Human Use (CHMP) of the...

Added 16 hours ago Drug news

Phase III VOYAGE 1 study of Tremfya shows efficacy in plaque psoriasis.- Janssen

The Janssen Pharmaceutical Companies of Johnson & Johnson announced new long-term data from the open-label period of the Phase III...

Added 16 hours ago Drug news

CHMP recommends approval of Darzalex + lenalidomide and dexamethasone in multiple myeloma.- Genmab

Genmab announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued...

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