Global Reach Health News – Page 25

January 19, 2023

FDA Accelerated Approval of Tukysa (tucatinib) in Combination with Trastuzumab for People
with Previously Treated RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer.

January 19, 2023 - Seagen Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Tukysa

January 17, 2023

FDA Approves Adacel for Immunization During Pregnancy to Help Protect Young
Infants Against Pertussis

January 17, 2023 - The U.S. Food and Drug Administration (FDA) has approved Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis

January 15, 2023

FDA Approves Rykindo (risperidone) Extended-Release Injectable Suspension for
the Treatment of Schizophrenia and Bipolar 1 Disorder

January 15, 2023 - Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale

January 13, 2023

FDA Signs Mutual Recognition Agreement between US and Switzerland

January 13, 2023 – The FDA signed the Agreement on Mutual Recognition between the Swiss Confederation and the U.S. Relating to Pharmaceutical Good Manufacturing Practice.

January 12, 2023

FDA Approves use of Rybelsus (semaglutide) as a First-Line Option for Adults with
Type 2 Diabetes

January 12, 2023 - The FDA has approved a label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg, allowing use as a first-line treatment option for adults

January 11, 2023

FDA Approves Airsupra (albuterol/budesonide) Metered-Dose Inhaler to Reduce
the Risk of Asthma Exacerbations

January 11, 2023 - Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention

January 6, 2023

FDA approves Leqembi™ (Lecanemab–IRMB) under the accelerated approval
pathway for the treatment of Alzheimer’s disease

January 6, 2023 - The U.S. Food and Drug Administration approved Leqembi (lecanemab-irmb)

January 3, 2023

Methylprednisolone No Benefit in Cardiopulmonary Bypass for Infants

Jan. 3, 2023 -- Prophylactic use of methylprednisolone does not reduce the likelihood of a worse outcome for infants undergoing surgery with cardiopulmonary bypass