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Magazine: CRISPR gene therapies cut through in 2023

Pharmaceutical Technology

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. The post Magazine: CRISPR gene therapies cut through in 2023 appeared first on Pharmaceutical Technology.

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Shorla gains FDA nod for first oral liquid version of Novartis' Gleevec

Fierce Pharma

In 2001, a Time Magazine cover story touted Novartis’ targeted leukemia treatment Gleevec (imatinib) as a new kind of “am | Shorla Oncology has scored an FDA approval for its strawberry-flavored drink version of Novartis' cancer drug Gleevec. Dubbed Imkeldi, it becomes the first oral liquid form of imatinib.

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FDA approves Sanofi and Regeneron’s Dupixent for bullous pemphigoid

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) as a treatment option for adults with bullous pemphigoid (BP), a condition that predominantly affects the elderly. In February 2025, the FDA accepted Dupixent’s supplemental biologics licence application (sBLA) for priority review.

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Grail plans FDA filing for cancer blood test after new trial

pharmaphorum

The company said it will now share the results with the FDA as part of the Galleri premarket approval application (PMA), along with preliminary data from a screening study in 140,000 volunteers aged 50 to 77, conducted with the UK NHS, that is being run in 150 locations across England, with final results expected next year.

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MSD receives FDA approval for Enflonsia to prevent RSV

Pharmaceutical Technology

MSD has received US Food and Drug Administration (FDA) approval for Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants. Can pharma tariffs “Make America Manufacture Again”? Credit: MargJohnsonVA/Shutterstock.

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FDA approves YolTech’s YOLT-101 for familial hypercholesterolemia

Pharmaceutical Technology

YolTech Therapeutics has received the US Food and Drug Administration (FDA) approval for its investigational new drug (IND) application for YOLT-101 to treat heterozygous familial hypercholesterolemia (HeFH). Can pharma tariffs “Make America Manufacture Again”? Credit: aipicte/Shutterstock. Don’t let policy changes catch you off guard.

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FDA approves UroGen’s Zusduri to treat recurrent bladder cancer

Pharma Times

“For the first time,… US patients facing recurrent LG-IR-NMIBC each year have access to an FDA-approved medicine,” Barrett said. UroGen’s president and chief executive officer, Liz Barrett, said the approval “represents a significant step forward for [the] company and for the treatment of recurrent LG-IR-NMIBC”.

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