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FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy

Fierce Pharma

FDA warns patients about compounded versions of Novo Nordisk's Ozempic, Wegovy kdunleavy Wed, 05/31/2023 - 13:02

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BioLineRx's Aphexda scores FDA nod to help myeloma patients undergo stem cell transplants

Fierce Pharma

After 10 years of stagnation, a new FDA approval could help more cancer patients become eligible for stem cell transplants. |

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FDA investigates 'serious risk' of secondary cancer following CAR-T treatment

Fierce Pharma

In a blow to CAR-T therapies, the FDA is investigating a “serious risk” of patients developing new cancers after treatment with these highly efficacious oncology drugs. |

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Takeda's Iclusig wins first-line FDA nod to treat rare Philadelphia chromosome-positive ALL

Fierce Pharma

Twelve years after Takeda's Iclusig (ponatinib) earned a restricted FDA approval to treat certain patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL), the U.S. regulator has signed off on a wider use.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

A recent draft from the FDA provides valuable insight. Learning Objectives: Dose-response curves and patient treatment: How do pharmacologic and toxicologic principles apply to the dosing of drugs in clinical development? What will the future hold for clinical research?

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Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

MedCity News

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

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Fierce Pharma Asia—BIO-WuXi break-off; Takeda's site closure; FDA's concern over Carvykti

Fierce Pharma

The FDA questioned whether Carvykti should be approved in an earlier line of multiple myeloma after noticing an early detriment to patient survival in a clinical trial. . | WuXi AppTec left BIO amid alleged biosecurity concerns and as U.S. lawmakers target certain Chinese biotechs. And more.

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