Zydus receives final approval from USFDA for Prucalopride Tablets

Prucalopride is prescribed for chronic idiopathic constipation

Sanofi’s GPRC5D monoclonal antibody earns ODD in US for multiple myeloma

FDA restrict 7-OH opioid products to protect consumers

7-OH is a concentrated byproduct of the kratom plant and has shown potential for abuse by binding to opioid receptors

Johnson & Johnson submits additional data to FDA on psoriatic arthritis

The submission is supported by results from the Phase 3b APEX study

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483

Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products

Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India

Zydus receives tentative approval from USFDA for Ibrutinib tablets

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad

Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

ImCheck’s ICT01 receives FDA ODD for treatment of acute myeloid leukemia

Clinical data showing unprecedented remission rates in newly diagnosed AML patients support advancing ICT01 into pivotal trials