Top

Category: Regulations


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 […]


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 […]


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 […]


FDA, Regulations

Opiant beats path to FDA after nasal overdose drug matches Narcan

May 3, 2022

Via: FiercePharma

Opiant Pharmaceuticals’ opioid overdose drug candidate has held its own against nasal naloxone in a trial of healthy volunteers, giving the company the data it needs to file for approval in the second half of the year. The candidate, OPNT003, […]


FDA, Regulations

FDA Issues Final Guidance on Electronic Postmarketing Safety Reports

May 3, 2022

Via: Biopharm International

FDA has issued the final guidance, Providing Submissions in Electronic Format– Postmarketing Safety Reports, the last in a series of guidance documents intended to assist industry when making certain regulatory submissions in electronic format to FDA’s Center for Drug Evaluation […]


FDA, Regulations

FDA Warns of Counterfeit Home COVID-19 Test Kits

May 3, 2022

Via: Drugs.com

The U.S. Food and Drug Administration is warning Americans to watch out for phony at-home, over-the-counter COVID-19 tests that look a lot like the real things. The counterfeit test kits may put you at risk of unknowingly spreading the disease […]


FDA, Regulations

FDA Approves Cuvrior (trientine tetrahydrochloride) for the Treatment of Wilson’s disease

May 2, 2022

Via: Drugs.com

Orphalan SA (“Orphalan” or “the Company”), an international orphan drug development and commercialisation company, today announces approval of Cuvrior™, a new salt of trientine (trientine tetrahydrochloride) by the United States Food and Drug Administration (FDA). Cuvrior™ is approved for the […]


FDA, Regulations

FDA clears Pfizer to restart Duchenne gene therapy trial, with new safeguards

April 28, 2022

Via: Biopharma Dive

Pfizer’s program, as well as a rival treatment from Sarepta Therapeutics, are among the most closely watched in all of gene therapy research. Both are in the final stages of testing and have shown they can help Duchenne patients produce […]