ZYDUS LIFESCIENCES LIMITED

The FDA issued a Complete Response Letter for CUTX-101, a potential treatment for Menkes disease, citing manufacturing facility deficiencies but no concerns about the drug's safety or efficacy data.

Alkem Laboratories has launched Pertuza injection 420mg/14mL, an indigenously developed pertuzumab biosimilar for HER2-positive breast cancer treatment in India.

ZyVet Animal Health has released the first FDA-approved generic phenylpropanolamine hydrochloride tablets for treating urinary incontinence in dogs, addressing a condition commonly affecting spayed females and aging dogs.

Zydus Lifesciences Global FZE has entered into an exclusive licensing and supply agreement with Netherlands-based Synthon BV to commercialize generic Ozanimod capsules for multiple sclerosis treatment in the US market.

Zydus Therapeutics announced positive results from the EPICS-III Phase 2b/3 trial of Saroglitazar in Primary Biliary Cholangitis patients who had inadequate response to standard therapy.

Zydus Lifesciences received final FDA approval for Diltiazem Hydrochloride tablets in four strengths (30 mg, 60 mg, 90 mg, and 120 mg) for treating chronic stable angina and coronary artery spasm.

The Delhi High Court denied F. Hoffmann-La Roche's request to access Zydus Lifesciences' manufacturing process for their Pertuzumab biosimilar, ruling that Roche failed to meet mandatory requirements under Section 104A of the Patents Act.

The Delhi High Court declined to order Zydus Lifesciences to disclose the manufacturing process of its breast cancer drug Sigrima after F. Hoffmann-La Roche failed to meet mandatory requirements under Section 104A of the Patents Act.

The Delhi High Court granted an interim injunction restraining Zydus Lifesciences from manufacturing or launching its biosimilar ZRC-3276, which references Nivolumab (Opdivo) as the reference product.

Zydus Lifesciences Limited has received final FDA approval for Celecoxib Capsules in four strengths (50 mg, 100 mg, 200 mg, and 400 mg) as a generic version of Celebrex.