News

AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan) has been accepted and granted Priority Review in the US for the treatment

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) as an add-on maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and an eosinophilic phenotype. Dupixent is the first biologic medicine approved in the U.S. to treat these patients.  

SIFI, a leading international ophthalmic company, announced that is has received a Notice of Allowance from the European Patent Office ("EPO") for EP4216966. The newly granted patent, entitled "formulation based on polyhexamethylene biguanide for use in the treatment

Travere Therapeutics, Inc., today announced a voluntary pause of enrollment in the Phase 3 HARMONY Study evaluating pegtibatinase for the treatment of classical homocystinuria (HCU). The voluntary enrollment pause enables the Company

ANI Pharmaceuticals, Inc. today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Ketoconazole Shampoo, 2%. ANI’s Ketoconazole Shampoo, 2% is the generic version of the reference listed drug (RLD) Nizoral®.

Merck known as MSD outside of the United States and Canada, today announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved new indications for KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in certain lung and urothelial cancers:

AstraZeneca’s Tagrisso (osimertinib)​ has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).

Amarex today announced its work on behalf of Gibson Oncology has resulted in an Orphan Drug Designation (ODD) by the United States Food and Drug Administration (FDA) for the drug LMP744.

Amgen today announced TEPEZZA® (JAN: Teprotumumab (Genetical Recombination)) has been approved for the treatment of active or high clinical activity score (CAS) Thyroid Eye Disease (TED) by Japan's Ministry of Health, Labour and Welfare (MHLW).

UCB, a global biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved BIMZELX® (bimekizumab-bkzx) for the treatment of adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis