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NICE (UK) terminated appraisal for Skyclarys (omaveloxolone) for treating Friedreich’s ataxia in people 16 years and over – Biogen

Written by | 18 Jun 2025

NICE (UK): NICE is unable to make a recommendation on omaveloxolone (Skyclarys) for treating Friedreich’s ataxia in people 16 years and over. This is because Biogen withdrew its… read more.

Bristol Myers Squibb to share major Breyanzi updates at ICML 2025

Written by | 17 Jun 2025

BMS announced the first disclosure of the primary analysis results of the marginal zone lymphoma (MZL) cohort of TRANSCEND FL, an open-label, global, multicenter, Phase II, single-arm study… read more.

NICE (UK) positive for Fintepla (fenfluramine) for treating seizures associated with Lennox–Gastaut syndrome in people 2 years and over – UCB

Written by | 17 Jun 2025

NICE (UK): Fenfluramine is recommended as an option for treating seizures associated with Lennox–Gastaut syndrome (LGS), as an add-on to other antiseizure medicines, for people 2 years and over…. read more.

NICE (UK) recommends Adcetris (brentuximab vedotin) in combination for untreated stage 3 or 4 CD30-positive Hodgkin lymphoma – Takeda

Written by | 16 Jun 2025

NICE(UK): Brentuximab vedotin plus doxorubicin, dacarbazine and vinblastine is recommended, within its marketing authorisation, as an option for untreated stage 3 or 4 CD30‑positive Hodgkin lymphoma in adults. It can… read more.

ACIP votes to expand recommendation for RSV vaccine Abrysvo, to include adults aged 50 to 59 at increased risk of disease – Pfizer

Written by | 15 Jun 2025

Pfizer Inc. announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to expand its recommendation for the use of… read more.

Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients – Medtronic

Written by | 14 Jun 2025

Medtronic plc announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut transcatheter aortic valve replacement (TAVR) system delivers a… read more.

NICE (UK) recommends Ontozry (cenobamate) for treating focal onset seizures in epilepsy – Arvelle Therapeutics

Written by | 13 Jun 2025

NICE(UK): Cenobamate is recommended as an option as an add-on treatment for focal onset seizures with or without secondary generalised seizures in adults with drug-resistant epilepsy that has… read more.

First participant dosed with acoramidis in ACT-EARLY, the first ever ATTR primary prevention study – BridgeBio Pharma

Written by | 12 Jun 2025

BridgeBio Pharma Inc. announced that the first asymptomatic participant with a known pathogenic transthyretin (TTR) variant, that may lead to transthyretin amyloid disease (either cardiomyopathy, ATTR-CM, polyneuropathy, ATTR-PN,… read more.

Sana Biotechnology announces upcoming podium presentation at ADA/IPITA 2025

Written by | 11 Jun 2025

Sana Biotechnology, a company focused on changing the possible for patients through engineered cells, announced an upcoming podium presentation highlighting ongoing clinical data from the investigator-sponsored, first-in-human study transplanting… read more.

FDA lifts clinical hold on IND applications for the Ebvallo (tabelecleucel) program – Atara Biotherapeutics + Pierre Fabre

Written by | 11 Jun 2025

Atara Biotherapeutics , a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases,  announced… read more.

FDA approves Novavax’s COVID-19 vaccine but with unusual restrictions

Written by | 10 Jun 2025

The FDA has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now… read more.

NICE (UK) recommends Joenja (leniolisib) for treating activated phosphoinositide 3-kinase delta syndrome in people 12 years and over – Pharming

Written by | 9 Jun 2025

NICE (UK): Leniolisib is recommended, within its marketing authorisation, for treating activated phosphoinositide 3‑kinase delta syndrome (APDS) in people 12 years and over. Leniolisib is recommended only if the… read more.

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