A 3D rendering of a neuron
Independent FDA Advisory Panel Recommends Approving ALS Drug
The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.
Independent FDA Advisory Panel Recommends Approving ALS Drug
Independent FDA Advisory Panel Recommends Approving ALS Drug

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

The group’s 7-2 ruling in favor of the therapeutic represents a shift from previous deliberations, in which data on its effectiveness was deemed insufficient.

drug approval
Building with sign reading “Novartis”
Two Children Die After Receiving Novartis Gene Therapy
Andy Carstens | Aug 12, 2022
No deaths had previously been associated with the muscle-wasting treatment Zolgensma.
EXCLUSIVE
Colorful pills and capsules on a calendar background
Clinical Trial Registry Errors Undermine Transparency
Catherine Offord | Aug 2, 2022
A lack of comprehension among some researchers about how to use ClinicalTrials.gov may be hindering public access to trial information and holding up drug study results, an investigation by The Scientist finds.
Child getting a bandaid put on arm by doctor.
FDA Green Lights COVID-19 Vaccines for Kids Under 5
Andy Carstens | Jun 17, 2022
Moderna and Pfizer-BioNTech shots could be given to the youngest kids as early as June 21.
A conceptual 3D illustration of motor neurons degrading
Canada Approves Experimental ALS Therapy
Andy Carstens | Jun 14, 2022
The country’s provisional go-ahead could increase pressure already being exerted on the US Food and Drug Administration to approve the therapy.
US Capitol with Senate building in the foreground
Robert Califf Confirmed to Lead FDA
Shawna Williams | Feb 15, 2022
A narrow Senate vote ends a 13-month period during which the agency has lacked a permanent commissioner.
Updated
Photograph of the US Food and Drug Administration’s sign outside their offices in Washington, D.C.
Lawmakers Request Information About Alzheimer’s Drug Approval
Annie Melchor | Sep 3, 2021
The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.
A stamp with a checkmark and the word FDA approved lying on its side on a white background.
Biogen Defends Newly Approved Alzheimer’s Drug
Jef Akst | Jul 27, 2021
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.
Biopharma Looks to the Netherlands as European Hub
Jef Akst | Feb 1, 2021
The recent move of the European Medicines Agency from London to Amsterdam is a reflection of the city’s vibrant life sciences and health sector and supporting industries.
Concerns over Efficacy and Cost of Muscle Wasting Treatments
Ruth Williams | Nov 11, 2020
Two new medications for treating a rare and deadly neuromuscular disease have high prices and questionable efficacies, say scientists.
Remdesivir Works Against Coronaviruses in the Lab
Abby Olena | Mar 20, 2020
The antiviral disables RNA replication machinery in MERS and SARS viruses. Can it beat back SARS-CoV-2?
2019 in Quotes
Catherine Offord | Dec 23, 2019
Scientists speak up about landmark drug approvals, political and environmental activism, and the redefinition of death.
an illustration showing amyloid plaques around brain cells
Biogen Presents Data on Efficacy of Alzheimer’s Drug
Shawna Williams | Dec 6, 2019
The company and its partner halted two clinical trials for futility early this year, but now say they’ll seek approval for aducanumab.
Ebola Vaccine Approved for Use in Europe
Jef Akst | Nov 11, 2019
Merck’s Ervebo gets its first regulatory greenlight. A decision from the US Food and Drug Administration is expected in the next few months.
a photo of the packaging for the drug Trikafta
FDA Approves New Cystic Fibrosis Drug
Shawna Williams | Oct 24, 2019
The treatment, Trikafta, increases lung function in most patients with the disease—but comes with a hefty price tag.
Antidepressant Approvals Could Herald New Era in Psychiatric Drugs
Bianca Nogrady | Oct 1, 2019
The FDA has given the green light to the first major new classes of antidepressant therapies in decades, opening up new avenues for therapeutic development.
First New Tuberculosis Drug Approved in 50 Years
Jef Akst | Aug 15, 2019
The US Food and Drug Administration green lights a therapy for an extreme form of multidrug resistant TB.
gene therapy approval used manipulated data
Some Data Backing Novartis Gene-Therapy Approval Manipulated: FDA
Nicoletta Lanese | Aug 7, 2019
The agency is now evaluating the implications of the corrupted data behind Zolgensma and whether to “take action” against the pharmaceutical company.
Esketamine, a Treatment for Depression, Receives FDA Approval
Carolyn Wilke | Mar 6, 2019
The nasal spray to ease intractable depression appears on the US market after decades without novel antidepressant treatments.
Genetic Sequencing Uncovers New Options for Multiple Myeloma Patients
Shawna Williams | Nov 1, 2018
A small pilot study suggests the approach can identify effective treatments already approved for other cancers.