BioSpace News Archive

The results of a new study recently published in Spine Deformity explore how quickly athletes can return to baseline sports activity following posterior spinal fusion, a treatment option for patients with severe adolescent idiopathic scoliosis.

COPAN Diagnostics Inc. is proud to announce the second FDA clearance of Colibrí™, a semi-automated pre-analytical processor that is a complementary part of WASPLab®, COPAN’s full laboratory automation system.

Renovacor, Inc. (NYSE: RCOR) today announced that the results of analytical and biophysical assays conducted as part of the company’s chemistry, manufacturing, and controls (CMC) development process for REN-001 will be featured in an upcoming poster presentation at the 29th European Society of Gene & Cell Therapy (ESGCT) Congress.

Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) today announced that it has received guidance from the U.S. Food and Drug Administration (FDA)'s review of the Company’s re-analysis of data from the FORWARD Phase 3 trial of fostamatinib for the treatment of patients with warm autoimmune hemolytic anemia (wAIHA).

scPharmaceuticals Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for the treatment of congestion due to fluid overload in adults with New York Heart Association Class II/III chronic heart failure.

Surrozen, Inc. today announced the presentation of data supporting the continued development of its lead therapeutic programs at United European Gastroenterology Week (UEGW), being held Oct. 8-11 in Vienna.

IRADIMED CORPORATION (the “Company”) (NASDAQ: IRMD) today announced that the Company voluntarily withdrew its 510(K) application on October 5, 2022, for its next-generation MR IV pump.

Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food & Drug Administration (FDA) approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive efficacy study of Ovaprene®, an investigational hormone-free monthly intravaginal contraceptive.

scPharmaceuticals Inc. today announced that the company has entered into a binding term sheet with respect to a $100 million secured debt facility with funds managed by Oaktree Capital Management, L.P. (“Oaktree”).

JW Therapeutics announced that the National Medical Products Administration (NMPA) of China has approved the supplemental New Drug Application (sNDA) for its anti-CD19 autologous chimeric antigen receptor T.