The Latest Breaking News from FDA

Ampio Pharmaceuticals Inc (NYSE: AMPE) received written responses from the FDA pursuant to a Type C meeting request regarding the AP-013 Phase 3 trial results. 

The U.S. FDA is warning that noninvasive prenatal screening (NIPS) tests may provide false results, such as stating a fetus may have a genetic abnormality when the fetus was healthy. FDA issues warning on possible false results from noninvasive prenatal screening tests. The agency noted that these tests, also known as…

Finch Therapeutics Group Inc (NASDAQ:FNCH) announced the layoff of 20% of its staff in a regulatory filing. The cuts will impact 37 full-time employees. The FDA in March placed a clinical hold on the Phase 3 trial for CP101, a donor-derived microbiome drug for Clostridioides difficile, as well as a partial hold…

Here's a roundup of top developments in the biotech space over the last 24 hours.

Teva Pharmaceutical Industries Ltd's (NYSE:TEVA) U.S. affiliate and MedinCell SA (OTC:MDCLF) have received FDA Complete Response Letter (CRL) regarding TV-46000/mdc-IRM for schizophrenia. The drug candidate is risperidone extended-release injectable suspension for subcutaneous use. Teva is reviewing its next steps based on the letter and will work closely with FDA to address their recommendations. Related: Teva Reports…

The demise of the federal transportation mask mandate was particularly jarring for many parents of children under five anxiously waiting for word on when COVID shots will become available to their kids.

Vaccine resisters have accused the federal government of pushing COVID-19 shots without ensuring that the benefits outweigh the risks. But what about when one of the people raising questions about the latest round of jabs is Paul A. Offit, arguably the most prominent supporter of vaccines in the nation, a…

Moderna’s updated COVID-19 booster shot shows even more efficiency against variants, the pharmaceutical company announced Tuesday, citing preliminary results from a trial.

Any biotech investor knows how important catalysts are for the companies in the space. One FDA approval or denial can make or break the price of the stock.  In the psychedelic space, catalysts could be even more important, as the industry as a whole is still in its infancy. 

The Checks and Balances Letter delivers news and information from Ballotpedia’s Administrative State Project, including pivotal actions at the federal and state levels related to the separation of powers, due process, and the rule of law.

BioXcel Therapeutics Inc (NASDAQ:BTAI) received strategic financing from Oaktree Capital Management and Qatar Investment Authority (QIA) for gross funding of $260 million. The Company will use the funding to support the commercial activities of Igalmi (dexmedetomidine) sublingual film indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder.…