Lawmakers Request Information About Alzheimer’s Drug Approval
Lawmakers Request Information About Alzheimer’s Drug Approval
The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.
Lawmakers Request Information About Alzheimer’s Drug Approval
Lawmakers Request Information About Alzheimer’s Drug Approval

The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.

The FDA granted the drug, called Aduhelm, accelerated approval earlier this summer in a process that’s since drawn scrutiny.

drug approval
Biogen Defends Newly Approved Alzheimer’s Drug
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
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
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
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
2019 in Quotes
Catherine Offord | Dec 23, 2019
Scientists speak up about landmark drug approvals, political and environmental activism, and the redefinition of death.
Biogen Presents Data on Efficacy of Alzheimer’s Drug
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
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.
FDA Approves New Cystic Fibrosis Drug
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
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
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.
Some Data Backing Novartis Gene-Therapy Approval Manipulated: FDA
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
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
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.
Hundreds of Supplements Spiked with Pharmaceuticals
Hundreds of Supplements Spiked with Pharmaceuticals
Ashley P. Taylor | Oct 14, 2018
FDA does little about it, study finds.
Two CAR T-Cell Therapies Greenlighted in Europe
Two CAR T-Cell Therapies Greenlighted in Europe
Jef Akst | Aug 28, 2018
Cancer treatments from Novartis and Gilead earn approval from EU regulators, but a first pass by the UK’s state-funded health service finds CAR T is too expensive. 
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Catherine Offord | Jul 17, 2018
Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.
FDA Approves Drug to Ease Symptoms of Opioid Withdrawal
FDA Approves Drug to Ease Symptoms of Opioid Withdrawal
Catherine Offord | May 17, 2018
Lucemyra is the first non-opioid drug to be approved in the U.S. specifically for this purpose.
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Advisors to FDA Recommend Approval of Gene Therapy for Blindness
Jef Akst | Oct 12, 2017
Spark Therapeutics’s Luxturna would be the first approved therapy in the U.S. that replaces or repairs a defective gene inherited from one’s parents.
Right-to-Try Bill Passes the Senate
Right-to-Try Bill Passes the Senate
Catherine Offord | Aug 4, 2017
The legislation removes restrictions for seriously ill patients to access experimental treatments that have not received FDA approval.