From now on, US physicians and researchers will have to get approval from the FDA before they can perform a stool transplant.
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After numerous high-profile safety scares, clinicians and regulators push to fix critical weaknesses in the FDA’s monitoring system for approved drugs.
Two experts propose replacing Phase 3 trials with smaller, faster alternatives and post-market surveillance to invigorate the pharmaceutical industry.
A retinal prosthesis, already available in Europe, can restore partial sight to people with a genetic disorder that causes blindness.
A company offering experimental stem-cell treatments will carry out its procedures in Mexico after the FDA warned that it would need approval to operate in the U.S.
Patient safety is paramount in regulating new stem cell treatments.
The US Food and Drug Administration approves the first flu vaccine made from recombinant proteins rather than a weakened virus.
After undergoing untested cosmetic surgery that uses stem cells to rejuvenate skin, a woman grew bone fragments in the flesh around one of her eyes.
The total number of new drugs approved this year ties last year for the highest since 2004, suggesting that the pharmaceutical industry is recovering.
The US Food and Drug Administration is taking steps to get new devices on the market sooner—and antibiotics may be next.
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