Clinical Trials Arena

FDA reversal on mRNA-1010 could transform the seasonal influenza vaccines market

Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010.

Pretzel recall update as FDA sets risk level

Exposure to the product "may cause temporary or medically reversible adverse health consequences," according to the FDA.

FDA Accepts Viatris Supplemental New Drug Application for MR-141 (Phentolamine Ophthalmic Solution 0.75%) for the Treatment of Presbyopia

Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for ...
STAT

Brain implants: What’s standing in the way of pivotal trials, FDA approval

Thirty years after scientists demonstrated how brain implants can help rhesus monkeys move robotic limbs using only their ...

A New FDA Plan Could Transform Treatment Access for Rare Disease Patients

Federal health officials yesterday issued a proposal that would make it easier for patients with rare diseases to receive treatment.

uniQure falls after FDA commissioner’s comments on rare disease therapy

Qure (QURE) stock plunged 30% as FDA’s Makary warned against approving drugs with morbidity risks. Read more here.
BMJ

The FDA and Moderna’s cosy relationship: how lax rules enable a revolving door culture

After holding oversight roles for covid vaccines, two regulators from the US Food and Drug Administration went to work for Moderna. Peter Doshi reports The physician-scientist Doran Fink worked his ...

FDA proposes new system for approving customized drugs and therapies for rare diseases

Federal health officials on Monday laid out a proposal to spur development of customized treatments for patients with hard-to-treat diseases, including for rare genetic conditions that the ...

FDA's vaccine advisory committee to meet in March for influenza virus strain

The U.S. Food and Drug Administration said on Wednesday its advisory committee is set to meet on March 12 to discuss and make recommendations on the strain composition of influenza virus vaccines for ...

Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s ...
SunStar

FDA delists hypertension med from VAT-exempt list

A MEDICINE for hypertension has been delisted by the Food and Drug Administration (FDA) from the updated list of Value-Added ...
Endocrinology Advisor

FDA Moves Toward Faster Drug Approvals

The US Food and Drug Administration (FDA) is relaxing a long-standing drug approval requirement for common diseases.