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CHMP recommends subcutaneous injection of Tecentriq for multiple cancer types – Roche

Written by | 19 Nov 2023

Roche announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of subcutaneous (SC, or under the skin). Tecentriq (atezolizumab)…. read more.

FDA approval of Voqenza (vonoprazan) tablets for the treatment of erosive GERD and relief of heartburn associated with erosive GERD in adults – Phathom Pharma

Written by | 18 Nov 2023

Phathom Pharmaceuticals, Inc. announced the FDA has approved Voqenza (vonoprazan) tablets 10 mg and 20 mg, a novel potassium-competitive acid blocker (PCAB), as a new treatment for adults… read more.

CHMP positive for Talzenna + Xtandi (talazoparib + enzalutamide) to treatmetastatic castration-resistant prostate cancer – Pfizer

Written by | 17 Nov 2023

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Talzenna…. read more.

CHMP positive for Mounjaro (tirzepatide) for the treatment of obesity – Eli Lilly

Written by | 16 Nov 2023

Eli Lilly’s Mounjaro is recommended for use in Europe for the treatment of obesity. The recommendation comes the same week the drug was approved for obesity treatment in… read more.

Submission of phase III study data on pulmonary tuberculosis to the EMA and FDA for Sirturo (bedaquiline) – Janssen Pharma

Written by | 15 Nov 2023

The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen), announced the submission of a Type II Variation application to the European Medicines Agency (EMA) for the Company’s medicine… read more.

CHMP positive for Omjjara (momelotinib) to treat myelofibrosis – GSK

Written by | 14 Nov 2023

On 9 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product… read more.

National Medical Products Administration has approved for Vocabria (cabotegravir) in combination with Rekambys (rilpivirine), the first and only complete long-acting HIV-1 injectable treatment – Viiv HealthCare

Written by | 13 Nov 2023

GSK plc has announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders announced that the National Medical Products… read more.

New clinical data on Rayaldee (ER calcifediol) presented at Kidney Week 2023 – OPKO Health Inc

Written by | 12 Nov 2023

OPKO Health, Inc. presented late-breaking clinical data on Rayaldee extended-release calcifediol (ERC) at the American Society of Nephrology (ASN) Kidney Week in Philadelphia. These data, presented in a… read more.

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.

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