FDA: Page 2

As Ebola drug review starts, Regeneron hopes to chart similar path for coronavirus therapy

Technology used to develop the antibody cocktail for Ebola is now being tapped by Regeneron to ready a COVID-19 treatment for clinical testing. 

By Ned Pagliarulo • April 16, 2020

Moderna's coronavirus vaccine plan may be possible, but a lot has to go in its favor

While Moderna has advanced rapidly in the month since this story was published, the biotech still faces many of the same challenges in the path to proving its vaccine.

By Ben Fidler • April 14, 2020

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 at 2:13 p.m.

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 09, 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 07, 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 07, 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 01, 2020

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 01, 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

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

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

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

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

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

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

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 5, 2020 at 2:36 p.m.

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 09, 2020

$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 at 4:55 p.m.

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 02, 2020