Briefs: Medicamen Biotech and Gland Pharma

Gland Pharma receives approval for Olopatadine Hydrochloride Ophthalmic Solution USP, 0.7% (OTC)

FDA grants priority review to Tzield for youngest Type 1 diabetes patients

Currently approved for patients eight and older, Tzield could now be used to delay the onset of stage 3 type 1 diabetes (T1D) in children diagnosed with stage 2 T1D

GSK’s Nucala approved in China for COPD with high eosinophils

Mepolizumab is the first and only monthly biologic in China tested for COPD patients with blood eosinophil counts (BEC) as low as 150 cells/µL

FDA nod to first-ever treatment for deadly post-transplant complication TA-TMA

The decision positions Yartemlea as the first and only approved inhibitor of the lectin pathway of complement

FDA delays Corcept’s hypertension drug, seeks more evidence

The FDA acknowledged that Corcept’s pivotal GRACE trial met its primary endpoint and that data from the GRADIENT trial offered confirmatory evidence

ENHERTU gains first-ever nod in China for metastatic breast cancer

The approval follows results from the DESTINY-Breast06 phase 3 trial, which showed ENHERTU significantly extended progression-free survival compared to chemotherapy

FDA setback for Sanofi’s Tolebrutinib in progressive MS

Tolebrutinib had been provisionally approved in the United Arab Emirates in July 2025 for nrSPMS to slow disability accumulation independent of relapse activity

EU nod to Wayrilz as breakthrough treatment for hard-to-treat ITP

Wayrilz represents a new approach to ITP by targeting the disease at its root through multi-immune modulation

Chugai’s Tecentriq gets green light in Japan for hard-to-treat Thymic Carcinoma

The drug had previously received orphan drug designation for this rare cancer on March 31, 2025

Amneal and mAbxience score FDA green light for two Denosumab biosimilars

Strides Pharma Inc's Chestnut Ridge facility gets 4 observations from USFDA

These observations are procedural in nature and the company does not anticipate any impact on supply of its commercial products

Japan nod to Dupixent for children with severe asthma

The decision is based on robust clinical evidence from the VOYAGE and EXCURSION studies

FDA nod to Boehringer Ingelheim’s JASCAYD for progressive pulmonary fibrosis in adults

The study found that nerandomilast effectively slowed lung function decline in patients, with discontinuation rates similar to placebo

Novo Nordisk’s Wegovy pill approved in US as first oral GLP-1 for weight management

Wegovy pill showed a mean weight loss of 16.6% in the OASIS 4 trial

Bayer wins Japan nod for finerenone in broad heart failure population

Finerenone is the first therapy targeting the mineralocorticoid receptor pathway to demonstrate cardiovascular benefits in heart failure patients

FDA grants breakthrough therapy designation to Enhertu for high-risk early breast cancer

This Breakthrough Therapy Designation highlights the impressive clinical benefit of Enhertu over the current standard of care

FDA go-ahead to Roche’s one-minute follicular lymphoma therapy

Full approval will depend on verification of clinical benefit in a confirmatory trial

FDA nod to MYQORZO for obstructive hypertrophic cardiomyopathy

The drug is designed to improve functional capacity and reduce symptoms by inhibiting cardiac myosin motor activity

Granules receives FDA tentative approval for generic Amphetamine ER orally disintegrating tablets

Tablets will be manufactured at Granules' US-based facility located in Chantilly, Virginia

EMA grants orphan drug status to Sanofi’s Efdoralprin Alfa for rare lung disease

Efdoralprin alfa, a recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein, showed superior efficacy to standard plasma-derived therapy in adults with AATD