European Pharmaceutical Review

DECEMBER 14, 2023

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Safety 110

Safety Medicine Competition Networking 110

World of DTC Marketing

FEBRUARY 4, 2021

regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

Pharma 180

Pharma Food and Drug Administration Side effects Safety 180

Pharmaceutical Technology

NOVEMBER 14, 2022

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson. MSCs and CAR-Ts for lupus.

Side effects 144

Side effects Patients Manufacturing Safety 144

European Pharmaceutical Review

SEPTEMBER 22, 2023

While new positive clinical data with anti-Abeta mAbs signal tremendous advancement and proof‑of-concept for the whole field, it is believed that the observed effects could still be improved and optimised in terms of greater clinical benefits, lower side effects and enhanced treatment convenience.

Food and Drug Administration 75

Food and Drug Administration Safety Patients Leads 75