Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.

Mindset Pharma was granted allowance by the U.S. Patent and Trademark Office for its application for a psilocybin-based family of drugs to treat central nervous system disorders.

In patients stricken with ulcerative colitis for less than five years, AMT-101 was nearly three times more effective in inducing clinical remission than the placebo after eight weeks.

Eisai and Biogen's BLA for lecanemab for Alzheimer's disease received FDA Priority Review with a target action date of January 6, 2023, while Roche's lymphoma drug scored the same designation.

A cancer drug co-developed by Coherus BioSciences and Junshi Biosciences, toripalimab, is getting another opportunity before the U.S. Food and Drug Administration.

Findings from a study support the claim that the risk of developing a serious issue, such as respiratory or cardiac issues, is much more probable in the first 30 days following infection from COVID-19.

A new study on gut microbiome activity suggests that diet and eating schedules may affect the body's propensity to become obese and unhealthy.

Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.

BioSpace connected with Theodore Laetsch, M.D., lead investigator of the pediatric larotrectinib trial (SCOUT), to gain more insight into the drug, the trial and how patients' lives are being affected.

During the past two years, life sciences companies have made a commitment to DEI - but have they taken internal action that increases diversity and promotes inclusive measures?

eFFECTOR Therapeutics is pioneering the development of selective translation regulation inhibitors (STRIs), a class of therapies that block the production of disease-driving proteins in cancer.

Researchers have created an inhalable COVID-19 vaccine that is shelf stable at room temperature for up to three months, targets the lungs specifically and effectively, and allows for self-administration via an inhaler. The researchers also found that the delivery mechanism for this vaccine - a lung-derived exosome called LSC-Exo - is more effective at evading the lung's mucosal lining than the lipid-based nanoparticles currently in use, and can be used effectively with protein-based vaccines.

Seagen announced positive data from its Phase II trial in colorectal cancer, and the FDA provided positive feedback supporting a Phase IIIb trial for ANeuroTech’s MDD drug.

The FDA lifted its clinical hold on Vertex Pharmaceuticals' Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).

As the calendar pages continue to turn, the FDA has a slew of novel drugs awaiting approval, several of which are likely to become game-changers for patients and key assets for companies.

The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.

Following the Supreme Court’s decision to overturn Roe v. Wade, abortion rights activists are calling for the FDA to consider making abortion medication Mifeprex an over-the-counter option for patients.

Quris has developed an alternative to testing on animal models, and each one is smaller than the head of a pin. It holds the potential to increase the currently terrible odds in drug development.

Many of Innate Pharma’s cancer-fighting products are making clinical progress. BioSpace spoke with the company's head of product portfolio strategy and business development, Yannis Morel, Ph.D.

Research scientists have found that a colony-stimulating factor 1 receptor inhibitor may also be a potential treatment for Duchenne muscular dystrophy.