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

USFDA completes inspection at Biocon Biologics’ Insulins facility at Malaysia

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

Dr. Reddy's invests US$ 620 million in Switzerland subsidiary

Bayer submits supplemental new drug application to USFDA seeking expanded indication for NUBEQA

NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)

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

Lupin signs distribution agreement with Celnova for orphan drug NaMuscla

Agreement enables access of EU-approved treatment for myotonia symptoms in non-dystrophic myotonic disorders to patients from Argentina and Colombia

Zydus receives USFDA final approval for Enzalutamide Capsules, 40 mg

Enzalutamide Capsules will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype

Zydus and CSIR-CDRI Lucknow to develop drug for CKD induced Osteoporosis

Studies suggest that the protein Sclerostin plays a key role in the dysregulation of bone metabolism

Alembic receives USFDA final approval for Paliperidone ER tablets

Paliperidone extended-release tablets are an atypical antipsychotic agent indicated for treatment of schizophrenia