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There were 960 press releases posted in the last 24 hours and 402,100 in the last 365 days.

Press Releases on September 15, 2023

1,191 Press Releases

Published on September 15, 2023 - 18:57 GMT

Withdrawn application: Skycovion, GBP510, Date of withdrawal: 01/09/2023, Initial authorisation

Based on the review of the data, at the time of the withdrawal, the Agency had concerns related to the quality of the medicine and the validation of the tests used to measure the immune response. In addition, the Agency considered that the application for …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:57 GMT

Referral: Havrix, hepatitis A virus (inactivated, adsorbed), associated names: Havrix and associated names, Article 30 referrals, ...

The European Medicines Agency (EMA) has started a review of Havrix and associated names, a vaccine used to protect adults and children against hepatitis A virus infection. The vaccine contains the inactivated (killed) hepatitis A virus and cannot cause the …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:57 GMT

Enviva Inc. (EVA) Investors Alert: Robbins LLP Reminds Investors of Class Action Filed Against Enviva Inc.

SAN DIEGO, Sept. 15, 2023 (GLOBE NEWSWIRE) -- Robbins LLP reminds investors that a shareholder filed a class action on behalf of all persons who purchased or otherwise acquired Enviva Inc. (NYSE: EVA) common stock between November 3, 2022 and May 3, 2023. …

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Published on September 15, 2023 - 18:56 GMT

Summary of opinion: Enhertu,trastuzumab deruxtecan, 14/09/2023, Positive

On 14 September 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 Enhertu. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Summary of opinion: Adcetris,brentuximab vedotin, 14/09/2023, Positive

On 14 September 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 Adcetris. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Summary of opinion: Finlee,dabrafenib, 14/09/2023, Positive

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 Finlee1, intended for the treatment of low- and high-grade glioma ( …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Summary of opinion: Yorvipath,Palopegteriparatide, 14/09/2023, Positive

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 Yorvipath1, intended for the treatment of chronic …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Summary of opinion: Ryeqo,relugolix,estradiol,norethisterone acetate, 14/09/2023, Positive

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

EMA recommends non-renewal of authorisation of Duchenne muscular dystrophy medicine Translarna

EMA’s human medicines committee (CHMP) has recommended not renewing the marketing authorisation for Translarna (ataluren), a medicine for treating patients with Duchenne muscular dystrophy whose disease is caused by a type of genetic defect called a ‘ …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Summary of opinion: ZILBRYSQ,Zilucoplan, 14/09/2023, Positive

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 Zilbrysq1, intended for the treatment of Myasthenia Gravis. The …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Summary of opinion: Aqumeldi,Enalapril maleate, 14/09/2023, Positive

On 14 September 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a Paediatric Use Marketing Authorisation (PUMA) for the medicinal product Aqumeldi, intended for the treatment of heart …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

EMA recommends non-renewal of authorisation of multiple myeloma medicine Blenrep

EMA’s human medicines committee (CHMP) has recommended not renewing the conditional marketing authorisation for Blenrep (belantamab mafodotin), a medicine used to treat multiple myeloma (a cancer of the bone marrow). Blenrep is given to adults who have …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:56 GMT

Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies

Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment. …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:55 GMT

Summary of opinion: Keytruda,pembrolizumab, 14/09/2023, Positive

On 14 September 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 Keytruda. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:55 GMT

Summary of opinion: Adcetris,brentuximab vedotin, 14/09/2023, Positive

On 14 September 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 Adcetris. The marketing authorisation holder for this …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:55 GMT

Summary of opinion: Ebglyss,Lebrikizumab, 14/09/2023, Positive

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 Ebglyss, intended for the treatment of atopic dermatitis. The …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:55 GMT

Summary of opinion: Herwenda,trastuzumab, 14/09/2023, Positive

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 Herwenda, intended for the treatment of HER2-positive breast and …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:54 GMT

Summary of opinion: Vanflyta,quizartinib, 14/09/2023, Positive

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 Vanflyta, intended for the treatment of acute myeloid leukaemia ( …

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:54 GMT

Summary of opinion: Kaftrio,ivacaftor,tezacaftor,elexacaftor, 14/09/2023, Positive

Summary of opinion: Kaftrio,ivacaftor,tezacaftor,elexacaftor, 14/09/2023, Positive

Distribution channels: Healthcare & Pharmaceuticals Industry
Published on September 15, 2023 - 18:54 GMT

Summary of opinion: Ryeqo,relugolix,estradiol,norethisterone acetate, 14/09/2023, Positive

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

Distribution channels: Healthcare & Pharmaceuticals Industry

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