Page 7 - Risk Evaluation News Today

State Attorney General Josh Stein and Republican state legislative leaders offered a federal judge opposing arguments this week in a lawsuit challenging North Carolina’s abortion pill restrictions.

State Attorney General Josh Stein and Republican state legislative leaders offered a federal judge opposing arguments this week in a lawsuit challenging North Carolina’s abortion pill restrictions. US District Judge Catherine Eagles asked parties in the case, Bryant v. Stein, to submit briefs Monday. Eagles will render a decision in the case without holding a trial.

This announcement is part of the overall evaluation period for the treatment, as the PDUFA target action date for pz-cel remains May 2024.

Maine and 17 other states are suing the federal agency, accusing it of maintaining restrictions on mifepristone even though it has been safely used to induce abortions for decades.

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a manufacturing process change resulting in a shorter manufacturing time for Yescarta® (axicabtagene ciloleucel). With this approval, Kite’s median turnaround time (TAT) in the U.S. is anticipated ...

PRINCETON, N.J.--(BUSINESS WIRE)--Jan 30, 2024--

U.S. FDA grants both FL and MCL applications Priority Review Applications based on results from TRANSCEND FL and TRANSCEND NHL 001, in which Breyanzi demonstrated clinically meaningful benefit with...

PRINCETON - Bristol Myers Squibb today announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended marketing authorization approval of Abecma for...

The FDA said Amgen’s Prolia may lead to low levels of calcium, or hypocalcemia. The osteoporosis drug’s black box warning follows an FDA review of Centers for Medicare & Medicaid Services studies that found Prolia led to a significant increase in the risk of severe hypocalcemia compared to treatment with an older class of medicines.

(BPT) - The winter season can be a challenging time of year for many – one that can bring post-holiday financial stress and exhaustion. Amid darker, colder days, how do