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Novartis completes divestment of ‘front of eye’ ophthalmology assets

Written by | 3 Oct 2023

Novartis announced that it has completed its divestment of ‘front of eye’ ophthalmology assets to Bausch + Lomb, a global eye health company, in a transaction valued up… read more.

European Commission approves Tyruko (natalizumab biosimilar), first and only biosimilar for multiple sclerosis in Europe – Sandoz

Written by | 2 Oct 2023

Sandoz, a global leader in generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorization for the first and only biosimilar Tyruko (natalizumab), developed by… read more.

Leqvio (inclisiran) is approved by MHLW for familial and non-familial hypercholesterolemia and for patients who are at a high risk of developing cardiovascular events – Novartis

Written by | 1 Oct 2023

Leqvio (inclisiran), became the first siRNA therapy for dyslipidemia approved in Japan. The drug was approved for familial and non-familial hypercholesterolemia and is intended for patients who are… read more.

MHLW (Japan) approval for Phesgo, the fixed-dose subcutaneous combination of Perjeta and Herceptin for HER2-positive breast and colorectal cancer – Chugai

Written by | 30 Sep 2023

Chugai Pharmaceutical Co., Ltd. announced that it has obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for Phesgo combination for Subcutaneous Injection MA, IN… read more.

European Commission approves Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe alopecia areata – Pfizer

Written by | 29 Sep 2023

Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for Litfulo (ritlecitinib) to treat adults and adolescents 12 years of age and older with severe… read more.

FDA approves Jardiance (empagliflozin) for the treatment of adults with chronic kidney disease – Boehringer + Eli Lilly

Written by | 28 Sep 2023

Boehringer Ingelheim and Eli Lilly and Company announced that the FDA has approved Jardiance (empagliflozin) 10 mg tablets to reduce the risk of sustained decline in estimated glomerular… read more.

FDA approval sought for frontline Tevimbra (tislelizumab) in locally advanced or metastatic esophageal squamous cell carcinoma – BeiGene

Written by | 27 Sep 2023

The FDA has accepted for review a biologics license application (BLA) seeking the approval of tislelizumab (Tevimbra) for use in the frontline treatment of patients with unresectable, recurrent,… read more.

CHMP positive for Finlee + trametinib for the treatment of low and high grade glioma – Novartis

Written by | 26 Sep 2023

On 14 September 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.

FDA grants priority review to application for Keytruda + concurrent chemoradiotherapy, as treatment for newly diagnosed high-risk locally advanced cervical cancer – Merck Inc

Written by | 25 Sep 2023

Merck Inc., known as MSD outside of the United States and Canada, announced the FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking… read more.

European Commission authorises Apretude (cabotegravir long-acting and tablets) for HIV prevention – Viiv HealthCare

Written by | 24 Sep 2023

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

Pfizer Japan files 20-valent pneumococcal vaccine for older adults and individuals at high risk of contracting an infectious disease caused by pneumococcus

Written by | 23 Sep 2023

Pfizer has filed Apexxnar, its 20-valent pneumococcal conjugate vaccine in Japan for the prevention of pneumococcal infection in older adults and individuals at a high risk of contracting… read more.

Quizartinib recommended for approval in EU by CHMP for patients with newly diagnosed FLT3-ITD positive AML – Daiichi Sankyo

Written by | 22 Sep 2023

Daiichi Sankyo announced that quizartinib has been recommended for approval in the European Union (EU) in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy,… read more.

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