Subscribe
Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors

Archive

FDA approves an updated label for Tryvio (aprocitentan) removing the REMS requirement – Idorsia

Written by | 26 Apr 2025

Idorsia announced that the FDA after having released Tryvio  (aprocitentan) from its REMS (Risk Evaluation and Mitigation Strategy) requirement (announced on March 17, 2025), has now approved the… read more.

Valneva receives first marketing authorization for Ixchiq vaccine in a chikungunya endemic country

Written by | 25 Apr 2025

Valneva SE announced that the Brazilian Health Regulatory Agency (ANVISA) approved Ixchiq vacccine for the prevention of disease caused by the chikungunya virus in individuals 18 years of… read more.

Pivotal 12-month effectiveness and safety data from SmartfIRE study presented at 2025 EHRA Congress – Johnson & Johnson / MedTech

Written by | 24 Apr 2025

Johnson & Johnson MedTech announced 12-month results from the SmartfIRE study, presented as a late-breaking presentation at the annual meeting of the European Heart Rhythm Association (EHRA) in… read more.

FDA approves neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis) – ARS Pharma

Written by | 23 Apr 2025

The FDA approved neffy (epinephrine nasal spray) for the emergency treatment of allergic reactions (Type I), including those that are life-threatening (anaphylaxis), in adult and pediatric patients who… read more.

Ebglyss (lebrikizumab-lbkz) single monthly maintenance injection achieved completely clear skin at three years in half of patients with moderate-to-severe atopic dermatitis – Eli Lilly

Written by | 22 Apr 2025

New results show Eli Lilly and Company’s Ebglyss achieved deep and sustained response for patients with moderate-to-severe atopic dermatitis (eczema) at three years. These findings from the ADjoin… read more.

Update on regulatory review of lecanemab for early Alzheimer’s disease by the European Commission – Eisai

Written by | 21 Apr 2025

Eisai Co., Ltd. and Biogen Inc. announced an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as a treatment for early AD (mild… read more.

CHMP positive opinion for upadacitinib (Rinvoq) for the treatment of adults with giant cell arteritis – Abbvie

Written by | 20 Apr 2025

AbbVie announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (Rinvoq 15 mg, once daily) for… read more.

Teva announces FDA filling acceptance for Ajovy (fremanezumab) in pediatric episodic migraine prevention

Written by | 19 Apr 2025

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced that the FDA  has accepted its supplemental Biologics License Application (sBLA) for  Ajovy (fremanezumab-vfrm) to expand the… read more.

NICE (UK) update for Crysvita (burosumab) for treating X-linked hypophosphataemia in children and young people – Ultragenix + Kyowa Kirin

Written by | 18 Apr 2025

NICE (UK): burosumab is recommended, within its marketing authorisation, for treating X‑linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children aged 1 year and over, and in… read more.

FDA grants 510(k) clearance for the Monogram mBôs TKA robotic system for orthpedic surgery – Monogram Technologies

Written by | 17 Apr 2025

Monogram Technologies Inc. an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, announced that the FDA has granted 510(k) clearance for… read more.

Relovair starts Phase III trial for Asthma

Written by | 16 Apr 2025

The first asthma patient has commenced treatment with Relovair (fluticasone furoate/vilanterol trifenatate) in an asthma exacerbation study, marking the start of the Phase III clinical development programme with… read more.

European Commission approves RSV vaccine Abrysvo to help protect adults aged 18-59 against RSV lower respiratory tract disease – Pfizer

Written by | 15 Apr 2025

Pfizer Inc.  announced that the European Commission (EC) has issued a decision amending the marketing authorization for  Abrysvo the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF)… read more.

Newsletter Icon

Subscribe for our mailing list

If you're a healthcare professional you can sign up to our mailing list to receive high quality medical, pharmaceutical and healthcare E-Mails and E-Journals. Get the latest news and information across a broad range of specialities delivered straight to your inbox.

Subscribe

You can unsubscribe at any time using the 'Unsubscribe' link at the bottom of all our E-Mails, E-Journals and publications.