FDA Approval

Clinical-stage biopharma company Ceruvia Lifesciences recently received FDA  approval for its Investigational New Drug (IND) application for a Phase 2 clinical trial to determine the efficacy and safety of proprietary synthetic psilocybin (SYNP-101) in treating obsessive-compulsive...

Psychedelic biopharma company Cybin Inc. (NEO: CYBN) has received FDA  Investigational New Drug Application (IND) approval for a Phase 1/2a clinical trial evaluating its proprietary CYB003 for treating major depressive disorder (MDD). The company had previously been granted...

The U.S. Food and Drug Administration (FDA) has approved Rhythm Pharmaceuticals’ (NASDAQ: RYTM) supplemental New Drug Application (sNDA) for IMCIVREE® (setmelanotide), a melanocortin-4 receptor (MC4R) agonist, for patients with Bardet-Biedl syndrome (BBS). The regulatory...

The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi’s (NASDAQ: SNY) lead drug candidate Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. The regulatory approval was supported by...

Cybin Inc. (CYBN), a biopharmaceutical company focused on progressing “Psychedelics to Therapeutics," has submitted an Investigational New Drug (or “IND”) application to the FDA. The aim is to begin the first phase (1/2a) of what would be the first human...

The meeting, which took place on May 18 between the psychedelic pharmaceutical biotech company Clearmind Medicine Inc. (CMNDF) and the US Food and Drug Administration marks the completion the pre-IND New Drug Application stage. This will allow Clearmind to move forward in the...

On Tuesday, three public companies in the psychedelics/biotech space announced significant milestones in their drug development pipelines. Field Trip Receives Notice Of Patent Allowance For Proprietary Psychedelic Molecule Field Trip Health (NASDAQ: FTRP) received a notice of allowance for a US...

The FDA has given 510(k) clearance for Boston Scientific Corp's (NYSE: BSX) Exalt Model B single-use bronchoscope for use in bedside procedures within the intensive care unit and operating room. The device can be used for a wide range of bronchoscopy procedures, including secretion...

Biotech stocks made a steady recovery over the week ended Oct. 2, although Friday's weakness trimmed some of the gains of the week. Companies working on anti-COVID-19 antibody treatments were in the news during the week. Sorrento Therapeutics Inc. (NASDAQ: SRNE) announced a second more...

Epidyolex, the first FDA approved CBD medicine for severe epilepsy in children, received Australian Therapeutic Goods Administration approval. GW Pharmaceuticals plc (NASDAQ: GWPH) confirmed Wednesday that TGA authorized the medicine to treat Lennox-Gastaut syndrome (LGS) or Dravet...

The U.S. Food and Drug Administration has issued a nine-page document to lead and encourage cannabis research. The guideline expands on FDA’s position regarding clinical research linked to the development of new drugs containing cannabis or cannabis derivatives. This...

Life sciences and healthcare company Thermo Fisher Scientific (NYSE: TMO) shipped the first batch of its novel coronavirus (COVID-19) testing kits to laboratories across the United States by Monday, chief executive officer Marc Casper told CNBC. What Happened Thermo Fisher currently has about 1.5...

Roche Holding AG (OTC: RHHBY) is shipping COVID-19 test kits approved under emergency use authorization (EUA) by the FDA. What Happened Roche’s Sars-CoV-2 Test for COVID-19 has begun shipping to hospitals and laboratories across the U.S. The test will enable high-volume, automated...

Biopharmaceutical company Epizyme Inc. (NASDAQ: EPZM) on Thursday said that its tazemetostat drug for the treatment of patients with epithelioid sarcoma had been approved by the Food and Drug Administration. What Happened The TAZVERIK drug has been approved, particularly for the...