FDA Archives

Biotech Jason Mast

Still hoping for looser FDA rules, Regeneron says it will test durable antibody for Covid

Biotech Jonathan Wosen

FDA’s Califf says congressional report on Aduhelm controversy contained ‘no surprises’

First Opinion Enes Hosgor and Oguz Akin

Four types of bias in medical AI are running under the FDA’s radar

Health Eric Boodman

‘It’s taken longer than I thought’: A former FDA commissioner on the loosened restrictions on abortion pills

The Aduhelm Files Rachel Cohrs

‘Rife with irregularities’: Congressional investigation reveals FDA’s approval of Aduhelm marked by secret discussions, breaches of protocol

Pharmalot Ed Silverman

McDonald’s adds targets for limiting antibiotic use in beef to its menu, but doesn’t say when

Biotech Jason Mast

Drugmakers ask regulators to change standards on new Covid antibody drugs for most vulnerable

Pharmalot Ed Silverman

Amid fears of superbugs, sales of antibiotics used in food-producing livestock barely declined last year

Politics Rachel Cohrs and Sarah Owermohle

Congress has a chance to close the FDA’s Theranos loophole

Politics John Wilkerson

FDA chief calls agency’s food program ‘under-supported, under-resourced’

First Opinion Scott Gottlieb and Mark B. McClellan

Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics

Biotech Kate Sheridan and Allison DeAngelis

FDA approves first fecal microbiome drug, setting stage for others

Health Lev Facher

Resistance to FDA’s opioid-disposal plan raises concerns about CADCA, a powerful advocacy group

Biotech Adam Feuerstein

FDA approves a gene therapy for the inherited bleeding disorder hemophilia B

Biotech Adam Feuerstein

GSK to withdraw blood cancer drug from U.S. market following confirmatory study setback

Pharmalot Ed Silverman

Pharmalittle: Type 1 diabetes drug is priced at $194,000; abortion opponents sue FDA over abortion pill approval

Health Nicholas Florko

To gin up opposition to the proposed menthol ban, tobacco companies are turning to gas station ads

Health Nicholas Florko

FDA formally warns companies behind Family Guy vapes, other illegal products marketed at kids

Politics Nicholas Florko

The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard

Biotech Adam Feuerstein

Immunogen wins FDA approval for targeted medicine to treat advanced ovarian cancer

Health Jason Mast

FDA panel votes against Veru’s drug for severe Covid

Special Report Matthew Herper

Here’s why we’re not prepared for the next wave of biotech innovation

Health Usha Lee McFarling

FDA panel asks for improvements in pulse oximeters

Health Usha Lee McFarling

Pulse oximeters and their inaccuracies will get FDA scrutiny. What took so long?

Pharmalot Jason Mast

FDA

Most Read

Listen: #JPM23, the future of Alzheimer’s, & rising Covid variants

Priorities pile up for HHS, FDA, CMS, NIH, and other health agencies

In wake of House investigation, 5 burning questions for FDA, Biogen, and Alzheimer’s treatments

The Aduhelm Operetta: ‘I’ve got a little list’

FDA, Biogen, and an Alzheimer’s drug approval: 8 key takeaways from congressional investigation

Seeking maximum profits, Biogen set an ‘unjustifiably high price’ for Alzheimer’s treatment, investigation finds

New FDA guidance explains that Plan B is not an abortion pill

Pharma wins changes in bill regarding FDA’s accelerated approval

All Coverage

Still hoping for looser FDA rules, Regeneron says it will test durable antibody for Covid

FDA’s Califf says congressional report on Aduhelm controversy contained ‘no surprises’

Four types of bias in medical AI are running under the FDA’s radar

‘It’s taken longer than I thought’: A former FDA commissioner on the loosened restrictions on abortion pills

‘Rife with irregularities’: Congressional investigation reveals FDA’s approval of Aduhelm marked by secret discussions, breaches of protocol

McDonald’s adds targets for limiting antibiotic use in beef to its menu, but doesn’t say when

Drugmakers ask regulators to change standards on new Covid antibody drugs for most vulnerable

Amid fears of superbugs, sales of antibiotics used in food-producing livestock barely declined last year

Congress has a chance to close the FDA’s Theranos loophole

FDA chief calls agency’s food program ‘under-supported, under-resourced’

Congress needs to update FDA’s ability to regulate diagnostic tests, cosmetics

FDA approves first fecal microbiome drug, setting stage for others

Resistance to FDA’s opioid-disposal plan raises concerns about CADCA, a powerful advocacy group

FDA approves a gene therapy for the inherited bleeding disorder hemophilia B

GSK to withdraw blood cancer drug from U.S. market following confirmatory study setback

Pharmalittle: Type 1 diabetes drug is priced at $194,000; abortion opponents sue FDA over abortion pill approval

To gin up opposition to the proposed menthol ban, tobacco companies are turning to gas station ads

FDA formally warns companies behind Family Guy vapes, other illegal products marketed at kids

The FDA has banned certain vapes and medicines. We still bought these 13 products in its backyard

Immunogen wins FDA approval for targeted medicine to treat advanced ovarian cancer

FDA panel votes against Veru’s drug for severe Covid

Here’s why we’re not prepared for the next wave of biotech innovation

FDA panel asks for improvements in pulse oximeters

Pulse oximeters and their inaccuracies will get FDA scrutiny. What took so long?

Pharmalittle: FDA advisers vote down pediatric brain cancer drug; AbbVie drops out of psoriasis partnership

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