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SKYTyphoid, a single-dose typhoid conjugate vaccine jointly developed by SK bioscience and the International Vaccine Institute, showed a positive immunogenicity and safety profile across age groups.

World Health Organization Grants Prequalification to Typhoid Conjugate Vaccine 

Trial data show Dupixent is the first and only novel biologic drug to significantly improve lung function and reduce severe acute exacerbations in adults with uncontrolled chronic obstructive pulmonary disease.

Dupixent sBLA Gets FDA Priority Review for Treatment of COPD With Type 2 Inflammation

Immune-Onc Therapeutics’ IO-202 is currently being analyzed as a monotherapy and in combination for patients with relapsed/refractory acute myeloid leukemia with monocytic differentiation or chronic myelomonocytic leukemia.

First-in-Class Novel Therapy for Chronic Myelomonocytic Leukemia Granted FDA Orphan Drug Designation 

Regeneron Pharmaceuticals’ linvoseltamab is currently in clinical development to treat adult patients with relapsed/refractory multiple myeloma who experienced disease progression following prior administration of at least three therapies.

FDA Grants Priority Review to Novel Bispecific Antibody for Multiple Myeloma 

Phase III results from Keytruda (pembrolizumab)’s NRG-GY018 trial help influence the agency’s decision.


Merck’s Primary Advanced, Recurrent Endometrial Carcinoma Treatment Given Priority Review by FDA

Tecvayli (teclistamab-cqyv) was the first bispecific antibody to gain FDA approval for the treatment of multiple myeloma.

FDA Approves Tecvayli at Reduced Dosing Frequency for Relapsed/Refractory Multiple Myeloma 

The FDA has assigned Servier’s New Drug Application for vorasidenib to treat IDH-mutant gliomas with a Prescription Drug User Fee Act action date of August 20, 2024.

FDA Accepts, Grants Priority Review to NDA for Vorasidenib in IDH-Mutant Gliomas

FDA accepts Bristol Myers Squibb's application for Krazati (adagrasib) plus cetuximab for patients who received prior treatment for KRASG12C-mutated locally advanced or metastatic colorectal cancer.

Krazati Combination for Advanced, Metastatic Colorectal Cancer Granted FDA Priority Review

Tagrisso (osimertinib) approved for use in combination with platinum-based chemotherapy in adults with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer harboring EGFR exon 19 deletions or exon 21 L858R mutations.

FDA Approves Tagrisso With Chemotherapy for EGFR-Mutated Advanced Lung Cancer

Iovance’s Amtagvi (lifileucel) gains FDA accelerated approval for adults with unresectable or metastatic melanoma.

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