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FDA approval for Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP and GLP-1 hormone receptors – Eli Lilly

Written by | 11 Nov 2023

The FDA approved Eli Lilly and Company’s Zepbound (tirzepatide) injection, the first and only obesity treatment of its kind that activates both GIP (glucose-dependent insulinotropic polypeptide) and GLP-1… read more.

ZORA real-world evidence demonstrates that Lokelma substantially increases cardiorenal patients’ chances of maintaining lifesaving RAASi therapy in hyperkalaemia patients – AstraZeneca

Written by | 10 Nov 2023

Results from the real-world ZORA observational multi-country study presented at the American Society of Nephrology (ASN) 2023 shows that treating hyperkalaemia (HK) with the potassium binder Lokelma (sodium… read more.

European Commission approves Ryeqo (relugolix 40 mg, estradiol 1.0 mg, and norethisterone acetate 0.5 mg) to treat endometriosis – Gedeon Richter

Written by | 9 Nov 2023

Gedeon Richter Plc. together with Sumitomo Pharma America, Inc. and Sumitomo Pharma Switzerland, GmbH has announce that the European Commission (‘EC’) has granted approval of a Type II… read more.

Approval from the MHRA for Krazati (adagrasib) as a targeted treatment option for patients with advanced non-small cell lung cancer (NSCLC) with a KRASG12C mutation – Mirati Therapeutics

Written by | 8 Nov 2023

Mirati Therapeutics, Inc. a commercial stage biotechnology company, announced the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for Krazati (adagrasib) as… read more.

Amgen presents new data that show blood decreases for adults treated with Krystexxa (pegloticase)

Written by | 7 Nov 2023

Amgen announced new data for Krystexxa (pegloticase) showing a decrease in blood pressure during treatment of adults living with chronic gout refractory to oral urate-lowering treatment; uncontrolled gout,… read more.

Rexulti (brexpiprazole) is filed in Japan for Alzheimer’s associated agitation – Otsuka

Written by | 6 Nov 2023

Otsuka Pharmaceutical has filed its antipsychotic agent Rexulti (brexpiprazole) in Japan for a label expansion into agitation associated with dementia due to Alzheimer’s disease. If approved, it would… read more.

World’s first expert recommendations on Remote Management of spinal cord stimulation systems published – Biotronik

Written by | 5 Nov 2023

For the first time, a panel of spinal cord stimulation (SCS) experts has developed best practices in the nascent field of remote SCS device management . The recommendations… read more.

SeaStar Medical provides regulatory update regarding Selective Cytopheretic Device use in pediatric acute kidney injury under a Humanitarian Device Exemption

Written by | 4 Nov 2023

SeaStar Medical Holding Corporation announces receipt of a correspondence from the FDA Center for Biologics Evaluation and Research (CBER) indicating that the Agency considers the Selective Cytopheretic Device… read more.

LianBio announces topline results from phase III LIBRA trial of TP 03 in Chinese patients with Demodex blepharitis

Written by | 3 Nov 2023

LianBio a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, announced topline results from the Phase III LIBRA clinical trial… read more.

Galapagos concludes strategic evaluation and signs letter of intent to transfer Jyseleca business to Alfasigma

Written by | 2 Nov 2023

Galapagos NV and Alfasigma S.p.A. announced that they have signed a letter of intent contemplating a transfer of the Jyseleca business to Alfasigma, including the European and UK… read more.

FDA approves Omvoh (mirikizumab-mrkz), a first-in-class treatment for adults with moderately to severely active ulcerative colitis – Eli Lilly

Written by | 1 Nov 2023

Eli Lilly and Company announced that the FDA has approved Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), the first and only interleukin-23p19 (IL-23p19) antagonist for the treatment… read more.

CLASP IID one year data confirms safety and efficacy of PASCAL system for degenerative mitral regurgitation – Edwards Life Sciences

Written by | 31 Oct 2023

Edwards Lifesciences Corporation announced one-year results from CLASP IID, the first randomized controlled trial that directly compares two contemporary mitral transcatheter edge-to-edge repair (TEER) therapies, as well as… read more.

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