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Pharma News for Pfizer, UCB, BioMarin
FDA Approves PENBRAYA for Most Common Serogroups Causing Meningococcal Disease; BIMZELX Approved Moderate to Severe Plaque Psoriasis; FDA Approves BioMarin’s VOXZOGO; FDA Fast Track Designation to ANPD001 for Parkinson’s Disease; UCB Announces FDA Approval of ZILBRYSQ; EMA Granted Orphan Drug Designation to Lisata’s LSTA1

UCB announces FDA approval of ZILBRYSQ for the Treatment of Adults with Generalized Myasthenia Gravis On the 17th of October 2023, UCB (Euronext Brussels: UCB) made an announcement regarding the approval of ZILBRYSQ® (zilucoplan) by the US FDA for the management of generalized myasthenia gravis (gMG) in adult pa...

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The Future is Here: BioMarin’s Roctavian First Hemophilia A Gene Therapy Paving the Way for a Cure

Hemophilia A is a rare genetic bleeding disorder that primarily affects males. Hemophilia A is the most common type of hemophilia, accounting for approximately 80% of all cases. It is estimated to occur in about 1 in 5,000 to 10,000 male births. As per the Centers for Disease Control (CDC) (2020), the estimated pre...

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FDA rejects BioMarin’s Valoctocogene Roxaparvovec; J&J inks $6.5B deal; Alzheon bags $47M; Research updates on diabetes

FDA rejects BioMarin's gene therapy and Gilead's filgotinib over concerns The FDA refused to approve BioMarin's hemophilia A gene therapy valoctocogene roxaparvovec. The U.S. regulator that had earlier told there was no requirement of an AdComm for the drug, aka, valrox, has issued a complete response (CRL) lett...

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Samsung biosim nod sets; Lilly’s med hits; BioMarin sees pricing; Spinraza scores; Klick creates

Samsung biosim nod sets J&J's Remicade up for tough fight Samsung Bioepis won FDA approval late Friday for its Remicade substitute, Renflexis (infliximab-abda), becoming the the second biosimilar to threaten that brand in the U.S. Not an unexpected event, and the launch isn’t expected until October because of bi...

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