FDA: Page 34
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Jacob Bell/BioPharma Dive
AstraZeneca and Merck drug wins approval for rare cancer after failing elsewhere
Koselugo, as the drug will be sold, is now cleared to treat an inherited disorder that affects around one in 3,000 people in the U.S.
By Jonathan Gardner • Updated April 13, 2020 -
Eye drug side effects are real, Novartis confirms in new warning
A recent review by the Swiss pharma found Beovu caused potentially serious side effects about once in every 1,000 injections.
By Jonathan Gardner • April 9, 2020 -
FDA delays decision on Roche spinal muscular atrophy drug
Roche says the three-month delay is needed for the FDA to review new data for risdiplam, which could become the first oral option for the disabling and often fatal disorder.
By Jonathan Gardner • April 7, 2020 -
FDA's new Keytruda review is a step for genetic medicine, immunotherapy
A decision on approval, expected by June 16, would be the fourth tissue-agnostic drug approval — and could help to validate an emerging immunotherapy biomarker.
By Ben Fidler • April 7, 2020 -
Contamination concerns spur FDA call for nationwide withdrawal of heartburn drug
Some pharmacies and manufacturers had already discontinued distribution of Zantac due to impurities involving a probable human carcinogen.
By Jonathan Gardner • April 1, 2020 -
Master Sgt. Hecht, Matt. (2020). [Photograph]. Retrieved from Flickr.
Under pressure, FDA touts speedy coronavirus drug development
By redeploying staff and request "triaging," the agency says it has streamlined its process for approving use of experimental drugs for COVID-19.
By Jonathan Gardner • April 1, 2020 -
With latest FDA submission, Bristol Myers keeps pace with Celgene milestones
Bristol Myers' second cancer cell therapy is now on track to be approved before the deadline set in its $74 billion acquisition of Celgene last year.
By Jonathan Gardner • March 31, 2020 -
Permission granted by Novartis
No sanctions for Novartis as FDA ends review of gene therapy violations
Quietly completing an inspection review, the FDA indicated it will not penalize Novartis for submitting altered data in its approval application for Zolgensma.
By Ned Pagliarulo • March 30, 2020 -
FDA clears emergency use of malaria pills to treat COVID-19
The unusual authorization, granted by the agency over the weekend, allows the federal government to distribute millions of doses of the drug to states.
By Ned Pagliarulo • March 30, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
5 FDA approval decisions to watch in the 2nd quarter
The FDA's focus is squarely on responding to COVID-19, yet the agency continues to review new drugs for other diseases. Among them: Roche's SMA therapy risdiplam and Intercept's NASH drug.
By Jacob Bell , Ben Fidler • March 30, 2020 -
Despite another delay, Intercept says its NASH drug remains on track
The coronavirus outbreak, though, adds more uncertainty to what will be a closely watched regulatory review of Intercept's therapy.
By Ben Fidler • March 26, 2020 -
Bristol Myers investors breathe easier as multiple sclerosis drug approved by FDA
Regulatory clearance for Zeposia is the first of three drug approval milestones that must be met for former Celgene shareholders to see the full value of the 2019 acquisition.
By Jonathan Gardner • March 26, 2020 -
In rare move, Gilead gives up 'orphan' status for experimental coronavirus drug
After sparking controversy, the biotech asked the FDA to rescind a designation designed to encourage research into therapies for rare diseases.
By Jonathan Gardner • March 25, 2020 -
Permission granted by Roche
Leukemia drug from Roche, AbbVie extends survival, study finds
Paired with chemotherapy, Venclexta succeeded in a Phase 3 acute myeloid leukemia trial just weeks after falling short in another combination study.
By Jonathan Gardner • March 23, 2020 -
Remdesivir, chloroquine move to forefront as White House tries to speed coronavirus response
Neither drug is approved for COVID-19, but officials seek to quickly study both in hopes of finding an answer for U.S. coronavirus patients.
By Jonathan Gardner • March 19, 2020 -
FDA scales back domestic inspections amid coronavirus outbreak
The agency's announcement comes a little over a week after it postponed nearly all overseas inspections, which are a critical oversight tool.
By Kristin Jensen • March 19, 2020 -
Jacob Bell/BioPharma Dive
FDA maps out plan for trials as coronavirus starts to threaten drug research
The agency is trying to get ahead of what could be widespread protocol changes to ongoing clinical trials.
By Ben Fidler • March 18, 2020 -
Courtesy of Regeneron Pharmaceuticals
Regeneron and Sanofi speed Kevzara into coronavirus trials
Positive signs from a Chinese test of Roche's Actemra support the companies' decision to start studying their anti-inflammatory drug against COVID-19.
By Jonathan Gardner • March 16, 2020 -
Yujin Kim / MedTech Dive, original photo courtesy of U.S. Food and Drug Administration
Coronavirus spread prompts FDA to postpone nearly all overseas inspections
The agency's decision was based on U.S. government travel restrictions, but it said "alternative tools and methods" will help it maintain oversight.
By Jonathan Gardner • March 10, 2020 -
Brian Tucker/BioPharma Dive
FDA, FTC put drugmakers on notice about tactics to block biosimilars
A joint agency meeting called out deceptive advertising and anti-competitive practices that may have kept the U.S. from catching up to Europe in establishing a market for lower-priced biologics.
By Jonathan Gardner • March 9, 2020 -
National Institute of Allergy and Infectious Diseases. (2020). "Novel Coronavirus SARS-CoV-2" [Image]. Retrieved from https://www.flickr.com/photos/nihgov/49565662436/in/album-72157713108522106/.
Tracking biopharma's response to the new coronavirus
The ongoing outbreak is a huge test for the biopharmaceutical industry and its ability to supply, develop, and test new drugs without disruption. Keep up with all of BioPharma Dive's coverage here.
By Jacob Bell • Updated July 7, 2020 -
Courtesy of Centers for Disease Control and Prevention
$8.3B in coronavirus funding set in motion as federal agencies ramp up response
The bill approved by both houses of Congress provides more than $2 billion to BARDA, and requires treatments developed using taxpayer money be available to the U.S. government at a "fair and reasonable price."
By Shannon Muchmore • Updated March 5, 2020 -
Courtesy of Sanofi
Sanofi wins US approval for myeloma drug key to its cancer ambitions
Sarclisa is the first cancer drug wholly owned by Sanofi to win an FDA OK in a decade — a milestone in the pharma's bid to play a larger role in oncology.
By Ned Pagliarulo • March 2, 2020 -
FDA seeks 'right balance' as it allows immediate use of coronavirus tests
"We are not changing our standards for issuing emergency use authorizations," said agency chief Stephen Hahn as the FDA works to expand U.S. testing.
By Susan Kelly • March 2, 2020 -
FDA reports first drug shortage due to coronavirus impact
Supplies of the drug, which the FDA did not identify, ran short as a result of issues at a site that produces the active ingredient. Other options are available, the agency said.
By Ned Pagliarulo • Updated March 2, 2020
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