BioSpace News Archive

Inari Medical, Inc. a medical device company with a mission to treat and transform the lives of patients suffering from venous and other diseases, announced the first patient enrollment in the PEERLESS II study.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) of reproxalap, an investigational drug candidate, for the treatment of dry eye disease.

ACELYRIN, INC. provided an update on its izokibep clinical development program, including its ongoing global Phase 2b/3 trial for izokibep in psoriatic arthritis.

Arcus Biosciences, Inc. announced that the Compensation Committee of the Company’s Board of Directors granted four new employees options to purchase a total of 12,600 shares of the Company’s common stock at an exercise price per share of $14.06, which was the closing price on November 24, 2023, and restricted stock units to acquire a total of 6,300 shares of the Company’s common stock.

Today, the U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment.

RemeGen Co. Ltd. (“RemeGen” or “the Company”) (9995.HK, SHA: 688331), a commercial-stage biotechnology company, today announced its two Phase II, open-label, multicenter, single-arm studies for Disitamab Vedotin (RC48-C005 and RC48-C009) have demonstrated consistent efficacy in patients with HER2-positive (immunohistochemistry 3+ or 2+) locally advanced or metastatic urothelial carcinoma (mUC) who have progressed through at least one previous line of systemic chemotherapy.

ENDRA Life Sciences to Participate in The Benchmark Company’s 12th Annual Discovery One-on-One Investor Conference.

Takeda to Present Data at 65th American Society of Hematology (ASH) Annual Meeting, Demonstrating Continued Commitment to Patients with Hematologic Diseases.

Biomea Fusion, Inc. today announced the acceptance of three abstracts presenting new clinical data from the ongoing escalation portion of its COVALENT-111 trial, evaluating BMF-219 as a potential treatment for people with type 2 diabetes, at the 17th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) taking place in Florence, Italy, 6-9 March 2024.

Evoke Pharma, Inc. announced that its recently issued U.S. patent related to GIMOTI, No. 11,813,231 is now listed in the U.S. Food and Drug Administration (FDA) publication, “Approved Drug Products with Therapeutic Equivalence Evaluations”, commonly known as the “Orange Book”.