FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
latest-news-card-1
Human Drugs

Merck Reports Positive Data for PCSK9 Inhibitor Enlicitide

Merck touts promising topline results from two Phase 3 clinical trials evaluating investigational enlicitide decanoate, an oral PCSK9 inhibitor for us...

Biologics

Novavax Vaccine OK'd After Political Interference: JAMA

A JAMA viewpoint article raises alarms about FDAs full approval last month of Novavaxs Covid-19 vaccine and the agencys unusual delay and politically ...

latest-news-card-1
Human Drugs

FDA Backs Jaguar on Cancer Diarrhea Drug Development

Jaguar Health plans to conduct a pivotal trial of crofelemer for cancer therapy-related diarrhea in breast cancer patients after gaining FDA support.

latest-news-card-1
Human Drugs

Pheast Gets Fast Track for Ovarian Cancer Drug

As it heads into a Phase 1 study, FDA grants Pheast Therapeutics a fast-track designation for PHST001 and its use in treating patients with advanced p...

FDA General

RFK Jr. Fires 17 CDC Vaccine Committee Members

HHS secretary removes all 17 members of the CDCs Advisory Committee for Immunization Practices (ACIP), and plans to appoint new members in the coming ...

latest-news-card-1
Human Drugs

Mercks RSV Therapy Approved by FDA

FDA approves a Merck BLA for Enflonsia (clesrovimab-cfor) for preventing respiratory syncytial virus lower respiratory tract disease in neonates and i...

latest-news-card-1
Human Drugs

Amneal Recalls Contaminated Tablets

Amneal Pharmaceutical recalls three lots of sulfamethoxazole/trimethoprim tablets because they may exhibit black spots on their tablet surface due to ...

Human Drugs

Arvinas Files NDA for Breast Cancer Drug

Arvinas files an NDA for vepdegestrant for treating patients with estrogen receptor-positive human epidermal growth factor receptor 2-negative ESR1-mu...

Medical Devices

Baxter Recalls Novum IQ Syringe Pump

Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the devices standby mode featur...

Human Drugs

House Subcommittee Advances FDA Budget Bill

A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committee.