Merck gets U.K. approval for sotatercept for PAH - MSN

Agamree Receives Positive Recommendation in Scotland and NICE Guidance in the UK for Duchenne Muscular Dystrophy

The Scottish Medicines Consortium (SMC) has accepted Agamree (vamorolone) for use within NHS Scotland for treating Duchenne muscular dystrophy (DMD) in patients aged four and older.
NICE has issued positive final guidance recommending Agamree for use in the NHS in England, Wales, and Northern Ireland for DMD patients aged four and older.

Merck's Winrevair Receives UK Approval for Pulmonary Arterial Hypertension

The UK's MHRA has approved Merck's Winrevair (sotatercept) for treating pulmonary arterial hypertension (PAH) in adults with moderate to marked physical activity limitations.
Winrevair, used with other PAH medicines, improves exercise capacity by targeting the underlying causes of the narrowing of lung arteries.

DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer

DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.

FDA Approves BridgeBio's Drug for Rare Heart Condition, Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

The FDA has approved BridgeBio's drug for transthyretin amyloid cardiomyopathy (ATTR-CM), a rare and often fatal heart condition.
This approval marks a significant advancement in treating ATTR-CM, offering a new therapeutic option for patients with this disease.

Pfizer Secures Approval for Hemophilia Drug Hympavzi in the EU - MSN

Nanomerics' OC134 Eye Drop Receives MHRA Authorization for Clinical Trials in Allergic Conjunctivitis

Nanomerics Ltd. has received MHRA authorization to begin human clinical trials for OC134, an eye drop for moderate to severe allergic conjunctivitis.
OC134 utilizes Nanomerics' Molecular Envelope Technology (MET) to enhance ocular penetration without irritation, addressing an unmet need for non-steroidal topical treatments.

FDA Grants Priority Review to Belzutifan for Advanced Pheochromocytoma and Paraganglioma

The FDA has granted priority review to belzutifan (Welireg) for treating advanced pheochromocytoma and paraganglioma (PPGL) in adult and pediatric patients.
The sNDA is based on positive objective response rate (ORR) and duration of response (DOR) data from the Phase 2 LITESPARK-015 trial.

AstraZeneca gets FDA approval for PNH drug Voydeya - MSN

EC approves Daiichi Sankyo's Vanflyta for acute myeloid leukaemia - MSN

Sotatercept Approved in Europe for Pulmonary Arterial Hypertension

Sotatercept (Winrevair; Merck) has received European Commission approval for pulmonary arterial hypertension (PAH) in adult patients with WHO Functional Class II-III.
The approval marks sotatercept as the first activin signaling inhibitor therapy approved in Europe for PAH, based on the Phase 3 STELLAR trial.