Top

Tag: FDA


FDA, Regulations

FDA Approves Radicava ORS (edaravone) for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

May 13, 2022

Via: Drugs.com

Mitsubishi Tanabe Pharma Corporation (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved Radicava ORS (edaravone), the oral form of edaravone, for the treatment of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that currently has no cure […]


Cell and Gene Therapy, Industry

FDA tags Editas’ thalassemia cell therapy an orphan drug as it rounds final bend in race to clinic

May 13, 2022

Via: FierceBiotech

Editas Medicine has picked up more regulatory privileges for its ex vivo gene-edited medicine, securing FDA orphan-drug designation in beta thalassemia ahead of the start of a clinical trial in the indication. The candidate, EDIT-301, is in development as a […]


News

Ready to go to FDA, can Hengrui’s China-made PD-1 liver cancer immunotherapy change the tides?

May 12, 2022

Via: FiercePharma

After two FDA rejections against China-made cancer immunotherapies this year, another Chinese pharma hopes it has the data to crack the agency’s doors open. But one major uncertainty remains. Thursday, Jiangsu Hengrui Medicine said a global phase 3 trial of […]


News

Bora Pharmaceuticals Acquires Eden Biologics

May 12, 2022

Via: Contract Pharma

Taiwan-based contract development and manufacturing organization (CDMO) Bora Pharmaceuticals recently announced the establishment of Bora Biologics Co., Ltd., to focus on the development of bio-pharmaceuticals. Bora Biologics has investors Taishin Healthcare Limited Partnership and Dr. Allen Chao, founder of Tanvex […]


FDA, Regulations

Company Hid Problems With COVID Vaccines From FDA

May 10, 2022

Via: Drugs.com

Evidence of quality control problems was hidden by a company contracted by the U.S. government to produce hundreds of millions of COVID vaccine doses, a new House committee report shows. It noted that Emergent BioSolutions didn’t disclose the issues at […]


FDA, Regulations

With spotlight on FDA, Congress weighs reforms to accelerated drug approvals

May 10, 2022

Via: Biopharma Dive

Over the past few years, the Food and Drug Administration has come increasingly under scrutiny for its program to grant speedy approvals to drugs that show early signs of benefiting patients with life-threatening diseases. These so-called accelerated approvals have ushered […]


Cell and Gene Therapy, Industry

LogicBio’s sun and shares rise again after FDA releases clinical hold on pediatric genome editing therapy

May 9, 2022

Via: FierceBiotech

The sun and shares are rising again at LogicBio after the FDA lifted a clinical hold on a genome editing therapy for children with a rare disorder. Shares of the Lexington, Massachusetts-based biotech were sent skyward by 60% as the […]


Industry, Vaccines

FDA Limits Use of Janssen COVID-19 Vaccine

May 6, 2022

Via: Biopharm International

FDA announced on May 5, 2022 that it has limited the emergency use authorization (EUA) of the Janssen COVID-19 vaccine to individuals 18 years of age and older for whom other authorized or approved COVID-19 vaccines are not accessible or […]


FDA, Regulations

Congress Presses FDA on Key Policies and Operations

May 4, 2022

Via: Biopharm International

FDA officials have faced a range of tough questions on Capitol Hill in recent weeks as part of the process for gaining timely agreement on legislation to reauthorize user fees for the agency’s medical product regulatory programs. On April 26, […]


FDA, Regulations

FDA Issues Warning Letters to Companies Illegally Selling CBD and Delta-8 THC Products

May 4, 2022

Via: Drugs.com

Today, the U.S. Food and Drug Administration issued warning letters to five companies for selling products labeled as containing delta-8 tetrahydrocannabinol (delta-8 THC) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). This action is the […]


FDA, Regulations

FDA spurns Coherus and Junshi’s China-made PD-1 cancer drug

May 3, 2022

Via: FiercePharma

The next China-developed immuno-oncology therapy to cross the FDA’s desk has been hit with bad news. Still, it will be half a year at least before Coherus BioScience and Junshi Bioscience get another crack at U.S. approval of their cancer […]


FDA, Regulations

No go for Zosano as FDA knockback triggers suspension of transdermal migraine patch program

May 3, 2022

Via: FiercePharma

Zosano Pharma’s headaches are intensifying. With the FDA again knocking back its transdermal migraine patch, the biotech has suspended its M207 program and made more layoffs to preserve its dwindling cash reserves. The patch uses microneedles to deliver zolmitriptan, a […]