Aurobindo Pharma receives USFDA approval for Cephalexin Tablets

The product is expected to be launched in Q3FY25

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad

Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time

Piramal Pharma Solutions announces US$ 80 million expansion plan for Sterile Injectables facility in Kentucky

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

The inspection concluded with the issuance of a form 483 with five observations

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression

FDA approves Bristol Myers Squibb’s Cobenfy

A first-in-class muscarinic agonist for the treatment of schizophrenia in adults