The Latest Breaking News from FDA

FDA clears Moleculin's IND application to Conduct Phase 1 Study of WP1066 for Recurrent Malignant Glioma

Moleculin Biotech, Inc. (MBRX) today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application of the drug candidate WP1066 for Recurrent Malignant Glioma The company plans to evaluate strategic partnerships and collaborations to conduct a Phase 1 open label clinical study of oral…

Benzinga · Apr 21, 2022

The Daily Biotech Pulse: Ampio Falls On Knee Osteoarthritis Trial Update, AstraZeneca's COVID-19 Antibody Data, CureVac-GSK's Bivalent COVID-19 Vaccine Data

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

Benzinga · Apr 21, 2022

Ampio Pharma Shares Fall As FDA Rejects Proposed Change In Knee Osteoarthritis Trial

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. 

Benzinga · Apr 21, 2022

Parents of kids under 5 still waiting for COVID shots

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.

Axios · Apr 20, 2022

Commentary: Confused about the second COVID booster? So are some of the experts

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…

Los Angeles Times · Apr 20, 2022

Moderna says redesigned COVID-19 vaccine booster may work better against variants

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

Tribune News Service · Apr 20, 2022

EXCLUSIVE: Catalysts To Watch For In The Psychedelic Space

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. 

Benzinga · Apr 19, 2022

Checks and Balances: SEC publishes proposed climate disclosures rule

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.

Ballotpedia · Apr 19, 2022

Oaktree, Qatar Investment Inject $260M In BioXcel To Fund Commercialization Of Schizophrenia Med

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.…

Benzinga · Apr 19, 2022

Civil service unions condemn Rees-Mogg’s ‘vindictive’ back-to-office drive

Bosses of FDA and PCS criticise attempt by efficiency minister to name and shame departments with more remote workers

The Guardian - UK · Apr 19, 2022