资讯

Lawmakers press FDA to target knockoff weight-loss drug
Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...
US FDA says J&J's unit issues correction related to surgical stapler
The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to ...
US FDA says J&J's Ethicon issues correction related to surgical stapler
Surgery, a unit of Johnson & Johnson , issued a correction for certain lots of a part related to its surgical stapler and ...
JD Supra19 小时
Before it hits the shelf: FDA reprocesses the new dietary ingredient notification process
On June 11, 2025, the US Food and Drug Administration (FDA) released educational materials to broaden dietary supplement manufacturers’ ...
PharmExec21 小时
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
Applied Clinical Trials Online20 小时
FDA Crackdown on Trial Design: What July’s CRLs to Replimune and Capricor Mean for Sponsors
Complete Response Letters recently issued by the FDA signal heightened scrutiny of trial design and reinforce the agency’s shifting regulatory expectations for sponsors and CROs.
Jyong Biotech's Plant‑Based Pipeline Targets Huge Markets But Risks Remain
Jyong Biotech targets urinary disorders with a novel botanical pipeline, but clinical and liquidity risks temper near-term upside. Read why MENS stock is a hold.
MPR22 小时
FDA Upgrades Recall on 160,000+ Bottles of Thyroid Medication
The recall of more than 160,000 bottles of levothyroxine sodium, which went into effect June 20, was upgraded to a Class II recall on July 23. Class II recalls occur when use of the drug poses a ...
Investing Snacks22 小时
Lilly’s Alzheimer’s Drug: A Ray of Hope?
Eli Lilly's Alzheimer's drug, donanemab (Kisqali), just got a thumbs-up from the European Medicines Agency's (EMA) expert ...