FDA approves Rezvoglar as second ‘interchangeable’ insulin biosimilar

Eli Lilly’s long-acting copycat drug, first approved in late 2021, now has a designation that will allow pharmacists to swap it for Sanofi’s Lantus.

By Christopher Newman • Nov. 18, 2022

FDA panel votes in favor of Ardelyx’s once-rejected kidney disease drug

The recommendation represents a surprising turnaround for Ardelyx’s drug, which the FDA put before an advisory committee only after the biotech appealed its rejection last year.

By Kristin Jensen • Nov. 17, 2022

For ImmunoGen, persistence pays off as FDA clears ovarian cancer drug

The approval makes Elahere the first wholly owned medicine the biotech has brought to market in its lengthy history.

By Jonathan Gardner • Nov. 15, 2022

Moderna data supports use of omicron booster over original vaccine

New results show the two-pronged booster the FDA cleared in August sparks a stronger immune response against omicron and its subvariants than Moderna’s original shot.

By Jonathan Gardner • Nov. 14, 2022

Under FDA pressure, GSK limits use of ovarian cancer drug

The drugmaker’s decision is the latest fallout from safety concerns that have emerged in testing of so-called PARP inhibitors, resulting in withdrawals by Merck & Co., AstraZeneca and Clovis Oncology. 

By Jonathan Gardner • Nov. 11, 2022

Regeneron wins broader US use of cancer immunotherapy

The FDA cleared Libtayo and chemotherapy for use in a broader group of lung cancer patients, a step forward in the company’s plan to compete with rivals Merck and Bristol Myers.

By Kristin Jensen • Nov. 9, 2022

FDA halts Verve plans to test gene editing therapy for heart disease in US

Verve didn’t say what led to the FDA’s decision, but claimed it hasn’t observed any safety issues in an ongoing trial in New Zealand and the U.K, where enrollment will continue.

By Ben Fidler • Nov. 7, 2022

FDA again delays review of Amicus rare disease drug

For the second time this year, the agency has put off a decision on Amicus' therapy for Pompe disease. European regulators are also reviewing the treatment and could soon issue an opinion.

By Christopher Newman • Oct. 31, 2022

What the FDA’s guidance on diversity means for rare disease sponsors

Bringing more diversity to clinical trials is a slow process and it takes time to get right. Learn how Worldwide Clinical Trials can diversify the reach of your orphan drug trial.

Oct. 31, 2022

FDA advisers split vote on GSK kidney disease drug, complicating regulatory path

The anemia pill could become the first drug of its kind to avoid a rejection from U.S. regulators. But an expert panel only supported its use in patients on dialysis, limiting its potential market.

By Kristin Jensen • Oct. 27, 2022

Speedy FDA approvals in focus as agency weighs withdrawal of preterm birth drug

The FDA will soon decide whether to pull Covis’ Makena from the market, more than three years after its confirmatory study failed. The delay highlights the need for reforms to the accelerated approval program, critics say.

By Jonathan Gardner , Christopher Newman • Oct. 21, 2022

FDA advisers back withdrawal of controversial drug for preterm birth

A committee of independent experts voted 14-1 that the agency shouldn’t allow the treatment from Covis Pharma to remain on the market while further testing is conducted.

By Jonathan Gardner • Updated Oct. 19, 2022

FDA opens case to withdraw controversial drug for preterm births

Beginning a high-stakes advisory meeting, CDER head Patrizia Cavazzoni said that Covis Pharma’s drug is ineffective and should not remain on the market.

By Ned Pagliarulo • Oct. 17, 2022

‘We have to find a way’: FDA seeks solutions to aid bespoke gene therapy

Gene therapies could help treat many ultra-rare diseases. But they may not get developed if drugmakers can’t build a sustainable business around them, CBER director Peter Marks said at a conference. 

By Ned Pagliarulo • Oct. 13, 2022

Omicron boosters from Pfizer, Moderna cleared by FDA for younger children

Pfizer's reformulated vaccine is now authorized for use in children at least 5 years of age, while Moderna's will be available for kids as young as 6.

By Ned Pagliarulo • Oct. 12, 2022

FDA rejects Supernus’ drug infusion device for Parkinson’s

The company said it will work with the FDA to address issues flagged by the agency in a complete response letter for the apomorphine infusion device.

By Delilah Alvarado • Oct. 10, 2022

Lilly looks to speed FDA review of new diabetes drug in obesity

A new fast track designation allows Lilly to begin the process of seeking approval of tirzepatide for obesity, though the drug will need to succeed in a second trial to get to market.  

By Jonathan Gardner • Oct. 6, 2022

FDA clears Roche test for AstraZeneca, Daiichi’s breast cancer drug

The diagnostic will support rollout of Enhertu, which recently became the first drug for breast tumors with low, but still detectable, levels of the protein HER2. 

By Nick Paul Taylor • Oct. 5, 2022

5 FDA decisions to watch in the fourth quarter

The regulator could soon approve medicines from Apellis, Gilead and GSK, and decide whether to pull a controversial preterm birth drug from the market.

By Ben Fidler , Ned Pagliarulo , Delilah Alvarado , Jacob Bell , Jonathan Gardner • Oct. 3, 2022

Federal watchdog highlights flaws in speedy FDA approvals

A newly published report by the HHS inspector general found that a substantial number of drugs given an accelerated approval by the FDA still haven’t proven whether they help patients.

By Jonathan Gardner • Sept. 30, 2022

BioMarin resubmits its hemophilia gene therapy to the FDA

The resubmission has been long awaited after BioMarin’s original application was unexpectedly rejected by the FDA two years ago. The company expects a decision around the middle of next year.

By Delilah Alvarado • Sept. 30, 2022

[PODCAST] Evolution and Innovation in Oncology Therapeutics Development

The “Evolution and Innovation in Oncology Therapeutics Development” podcast series explores the role of multi-biomarkers in precision oncology.

By BioPharma Dive's studioID • Sept. 30, 2022

ALS drug approved by FDA in closely watched decision, marking win for patients, developer

The drug, which will be sold as Relyvrio, showed modest benefits in function and survival in testing. It also became the latest test of the FDA's flexibility toward new therapies for neurological disorders.

By Jacob Bell • Updated Sept. 30, 2022

Pfizer, BioNTech seek FDA clearance for updated COVID-19 booster in children

The request, if cleared, would make U.S. kids between 5 through 11 eligible to receive a "bivalent" shot targeting components of the omicron variants currently circulating. 

By Delilah Alvarado • Sept. 26, 2022

FDA user fee package to be included in bill to fund government, avoid shutdown, senators say

A “practically clean” version of the bill will allow the FDA to continue its review and testing programs, while leaving more ambitious goals to be dealt with in a funding bill later this year.

By Elise Reuter • Sept. 23, 2022