Tag: FDA
-
Trial Cleared for Lab-Grown Replacement Knee Cartilage
A biotechnology company creating living tissue from a person’s stem cells says it received FDA clearance for a clinical trial of its replacement knee cartilage.
-
Cancer Immunotherapy Biotech Issues $80M IPO
A biotechnology company designing immunotherapies for solid tumor cancers with a patient’s white blood cells is raising $80 million in its initial public offering or IPO.
-
One-Time Crispr HIV Therapy Given Fast-Track Status
A treatment for HIV taken just once, using the genome-editing technology Crispr, is receiving fast-track designation from the U.S. Food and Drug Administration.
-
Low-Dose Oral Film Reduces Mental Disorder Agitation
Interim results from a clinical trial show a drug given as a dissolvable oral film in a lower dose reduces agitation in people with bipolar disorder and schizophrenia.
-
Brain-Computer Device Company Gains $33M in Early Funds
A company creating brain-computer interface devices to help people with disabling communications impairments is raising $33 million in its first venture round.
-
Real World Evidence Shown to Emulate Some Clinical Trials
A study of insurance claims records matching the design of randomized clinical trials shows claims data can in some cases resemble clinical trial results to make causal inferences.
-
Biotech Gains $53.7M Infectious Disease Test Award
A maker of diagnostics for infectious diseases is receiving a $53.7 million contract to develop and validate reliable home molecular tests for Covid-19 and flu infections.
-
Biotech Group Blasts Reproductive Drug Ruling
A biotechnology industry group calls Friday’s ruling in a Federal district court to suspend approval of the drug mifepristone “an assault on science.”
-
Trial Okayed for Glaucoma Treatment Implant
A developer of treatments for eye diseases says it received clearance from FDA to begin a clinical trial of a sustained-release implant therapy for glaucoma.
-
Trial to Test Low-Dose Psilocybin for Mental Distress
A developer of mental health therapies from psychedelic compounds says it received FDA clearance for a clinical trial testing low doses of psilocybin.