News – Global Reach Health

October 10, 2024

GENERIC DRUG APPROVALS

September 30, 2024 - Drospirenone Tablets 4mg
Approved: September 30, 2024 - Lupin Ltd.
Indicated for: Contraception
Generic for: Slynd

September 30, 2024

FDA Approves Otulfi™, a Biosimilar to Stelara®

September 30, 2024 – Fresenius Kabi, and Formycon AG, announced the U.S. Food and Drug Administration (FDA) approved Otulfi^TM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara^®.

September 27, 2024

FDA Approves Flyrcado Radioactive Diagnostic for Enhanced Diagnosis of CoronaryArtery Disease

September 27, 2024 GE HealthCare announced the U.S. Food and Drug Administration (FDA) granted approval of Flyrcado (flurpiridaz F-18) injection

September 26, 2024

FDA is Alerting Patients and Health Care Professionals About the Voluntary Withdrawal of Oxbryta from the Market Due to Safety Concerns

September 26, 2024 – The FDA is alerting patients, caregivers, and health care professionals that Oxbryta (voxelotor) is being voluntarily withdrawn from the market by the manufacturer

September 26, 2024

FDA Approves Cobenfy, a First-In-Class Muscarinic Agonist for the Treatment ofSchizophrenia in Adults

September 26, 2024 Bristol Myers Squibb announced the U.S. Food and Drug Administration (FDA) approved Cobenfy (xanomeline and trospium chloride), an oral medication for the treatment of schizophrenia in adults.

September 25, 2024

FDA Approves Aqneursa for the Treatment of Niemann-Pick Disease Type C

September 25, 2024 - IntraBio Inc. announced the U.S. Food and Drug Administration (FDA) approved Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing ≥15kg

September 20, 2024

Gilead Issues Voluntary Nationwide Recall of One Lot of Veklury (Remdesivir) for Injection 100mg/vial Due to the Presence of a Glass Particle

September 20, 2024 – Gilead Sciences, Inc. announced it is issuing a voluntary recall of one lot of Veklury (remdesivir) for Injection 100mg/vial, to the consumer level.