FDA

MEI, Kyowa stop lymphoma drug trials after FDA meeting

The decision not to run a Phase 3 trial is the latest fallout from U.S. regulators’ recent moves to closely evaluate a class of drugs called PI3 kinase inhibitors. 

By Jonathan Gardner • Dec. 6, 2022

Verve shares slide after company reveals details on FDA trial hold

In a letter to the biotech, the regulator asked for more information on its gene editing medicine for heart disease as well as on its potential risks.

By Delilah Alvarado • Dec. 6, 2022

Rigel wins US approval of rival drug to Servier leukemia treatment

The approval gives Rigel, a biotech that’s been around since the mid-1990s, its second marketed medicine and a competitor to Servier’s Tibsovo.

By Christopher Newman • Dec. 2, 2022

FDA approves first microbiota-based treatment

The regulatory OK, a milestone for microbiome-based drug research, is for a medicine from Ferring Pharma that treats a recurrent type of gut infection.

By Christopher Newman • Dec. 1, 2022

Roche pulls Tecentriq in bladder cancer, completing sweep of ‘dangling’ accelerated approvals

The pharma will no longer market the immunotherapy in the U.S. for urothelial carcinoma, the indication for which the drug was first approved six years ago.

By Jonathan Gardner • Nov. 29, 2022

Spectrum to lay off R&D staff after FDA drug rejection

The company will cut its R&D workforce by 75% and discontinue development of its experimental lung cancer drug poziotinib.

By Delilah Alvarado • Nov. 28, 2022

FDA grants speedy review to Sarepta’s Duchenne gene therapy

The agency will decide on an accelerated approval of Sarepta’s treatment by May 29, months before results are expected from a potentially confirmatory Phase 3 trial.

By Jonathan Gardner • Nov. 28, 2022

FDA approves first gene therapy for hemophilia B

The one-time treatment, which is for the less common “B” form of the bleeding disorder, will be sold in the U.S. by maker CSL for $3.5 million per infusion. 

By Ned Pagliarulo • Updated Nov. 23, 2022

GSK to pull blood cancer drug from US market after study failure

The British drugmaker has begun the process of withdrawing its multiple myeloma treatment Blenrep following a request from the FDA.

By Ned Pagliarulo • Nov. 22, 2022

First-of-its-kind Type 1 diabetes drug wins FDA approval

Provention Bio’s teplizumab is meant to prevent the onset of Type 1 diabetes. To be sold as Tzield, the drug will cost $193,900 for a typical full regimen. 

By Delilah Alvarado • Nov. 18, 2022

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