BioSpace News Archive

Today, the U.S. Food and Drug Administration issued warning letters to 10 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, advising them that selling these products, which lack premarket authorization, is illegal, and therefore they cannot be sold or distributed in the U.S

The U.S. District Court for the Eastern District of Washington entered a consent decree between the U.S. Food and Drug Administration and Valley Processing, Inc. of Sunnyside, Washington, along with the company’s owner and president, Mary Ann Bliesner, to stop distributing adulterated juice products until the company complies with the Federal Food, Drug, and Cosmetic Act and other requirements listed in the consent decree.

Beyond Air, Inc. (NASDAQ: XAIR), a clinical-stage medical device and biopharmaceutical company focused on developing inhaled nitric oxide (NO) for the treatment of patients with respiratory conditions, including serious lung infections and pulmonary hypertension, and gaseous NO (gNO) for the treatment of solid tumors, today announced that it will report financial results for its third fiscal quarter ended December 31, 2020 on Tuesday, Februa

Accelerated approval of DARZALEX FASPRO®-based combination regimen supported by the Phase 3 ANDROMEDA study demonstrating a significantly higher hematologic complete response rate in this rare and serious blood cell disorder [15-January-2021] HORSHAM, Pa. , Jan. 15, 2021 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the

- DARZALEX FASPRO® Utilizing ENHANZE® Represents First and Only Approved Treatment for Patients with Newly Diagnosed AL Amyloidosis - - Accelerated Approval of DARZALEX FASPRO®-based Combination Regimen Supported by the PHASE 3 ANDROMEDA Study Demonstrating a Significantly Higher Hematologic Complete Response Rate in this Rare and Serious Blood Cell Disorder -

- Enveric Biosciences, Inc. (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, today announced the closing on January 14, 2021 , of its $10 million registered direct offering consisting of the purchase and sale

Cipher Pharmaceuticals Inc. (TSX: CPH) (“Cipher” or “the Company”) today announced it has received an arbitration award in the previously announced dispute between the Company and Bausch Health Ireland (“Bausch Health”) relating to the License, Development and Commercialization Agreement (the “Agreement”) of Trulance®

Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Australian-based regenerative medicine company, Orthocell Ltd, has achieved US 510k clearance to market and supply its collagen medical device Striate+TM in the US dental bone and tissue regeneration market.

Diaphragm pacing involves electrically stimulating a patient’s diaphragm muscles and nerves using a lightweight, battery-powered system. This causes the diaphragm to contract so that air is pulled into the lungs. It helps the patient to breathe normally.