regulation, FDA, drug development

Given within three days of symptom onset, the pill combination was nearly 90 percent effective at preventing high-risk patients from developing severe illness in a clinical study.

The US Food and Drug Administration has called for a federal investigation of its own regulatory review process after widespread criticism of its decision on Aduhelm.

Now more than ever before, recruiting patients for a research study doesn’t have to mean getting them to leave their homes.

As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.

Although scientists debate the ethics of deliberately infecting volunteers with SARS-CoV-2, plenty of consenting participants have been exposed to all sorts of pathogens in prior trials.

The physician-researcher laid the groundwork for genetic cloning and led the US Food and Drug Administration as the country faced the AIDS crisis in the 1980s.

The US Food and Drug Administration green lights a therapy for an extreme form of multidrug resistant TB.

The agency cites safety concerns with customers of Genetech who reported getting E. coli infections and sends letters to other stem cell companies reminding them to follow the rules.

What can be done to lower development costs and drug prices?

Among a subset of US Food and Drug Administration regulators who leave the agency, more than half go to work for pharmaceutical companies, researchers report.

The change should allow patients with fatal illnesses easier access to experimental drugs, but gaining permission from drug companies remains the biggest challenge.

FDA designations promise to expedite the approval of drugs for conditions ranging from infectious disease to cancer.

A panel of experts advised the US Food and Drug Administration that BioMarin Pharmaceutical has not demonstrated efficacy of its new drug for Duchenne muscular dystrophy.

Weight-loss drugs that target newly characterized obesity-related receptors and pathways could finally offer truly effective fat control.

Pharma edition

The US Food and Drug Administration green lights the first medicine produced by a 3-D printer for use in the human body.

In the midst of a debate about an experimental drug’s early approval, the US Food and Drug Administration requests that full trial results be released.

Biotech company Genervon has requested accelerated approval for its experimental ALS drug after a small but promising Phase 2 trial. Patients advocate for its acceptance, while researchers urge caution.

While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.