资讯

BioPharma Dive1 小时

Rocket can resume gene therapy trial after FDA lifts hold

The company plans to continue with a lower dose and a change in the pre-treatment regimen after a trial participant died ...

Gene Therapy Trial Can Restart After Patient Death, FDA Says. The Sector Remains Depressed.

Rocket’s relatively quick reprieve is good news for the stock, and suggests that the FDA remains actively supportive of gene ...
BioSpace2 小时

FDA Looks to Raise Survival Bar for Cancer Drug Approvals in New Draft Guidance

The FDA recommends that companies use overall survival as a primary endpoint for clinical trials where feasible. The new ...
Michigan Advance3 小时

Kennedy’s anti-vaccine strategy risks forcing shots off market, manufacturers warn

Dining under palm trees on a patio at Mar-a-Lago in December, President-elect Donald Trump reassured chief executives at ...
BioSpace10 小时

With Prasad Back at FDA, Capricor To Fight CRL for DMD Cardiomyopathy

Capricor Therapeutics met with the FDA last week for a type A meeting, during which CEO Linda Marbán aimed to explain to the ...
Fierce Biotech1 天

FDA pushes back PDUFA date for Regenxbio’s Hunter syndrome gene therapy

Delays from the Food and Drug Administration continue to pile up, with Maryland-based Regenxbio the latest to report the review of one of its assets ...
Fierce Pharma2 天

Sarepta shares more Elevidys safety data in response to patient group's FDA petition

Sarepta Therapeutics has provided additional safety data on its gene therapy Elevidys as a Duchenne muscular dystrophy ...
MedPage Today4 天

First Therapy Approved for HPV-Related Respiratory Disease

This first approved medical therapy for RRP generates an immune response against the causative HPV strains. It uses ...
Healio4 天

FDA approves Papzimeos as first therapy for recurrent respiratory papillomatosis

The FDA approved the adenoviral vector-based immunotherapy, zopapogene imadenovec-drba, for treatment of certain patients ...
Dermatology Advisor5 天

Vinay Prasad Returns to FDA After Being Ousted

Dr Vinay Prasad will return to head the FDA’s Center for Biologics Evaluation and Research less than 2 weeks after being ousted.

Precigen shares jump after US FDA approves first therapy for rare respiratory disease

Precigen's immunotherapy for a rare respiratory disease has become the first treatment to win U.S. regulatory approval for ...

Precigen surges on FDA approval for immunotherapy

Precigen (PGEN) stock jumps as the FDA approves the company's gene therapy Papzimeos for adults with recurrent respiratory ...