BioSpace News Archive

Following a series of stumbles in Type 1 diabetes, Lexicon’s dual SGLT inhibitor sotagliflozin finally won the FDA’s approval in heart failure and will be marketed as Inpefa.

Marstacimab decreased bleeding rates by 92% in patients with severe hemophilia A and moderately severe to severe hemophilia B without inhibitors.

Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.

Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.

DUO-E trial data show AstraZeneca’s Imfinzi, either alone or in combination with Lynparza, boosts progression-free survival in endometrial cancer.

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healthŌme™ Inc., a leading genomics-based, health navigation company, today announced its acquisition of Kailos Genetics, LLC, a CLIA-certified and CAP-accredited genetic testing laboratory and supplier of clinical grade laboratory reagents for next-generation sequencing.

Following a special meeting of its stockholders, Seagen Inc. (Nasdaq: SGEN) today announced that its stockholders voted to approve a proposal to adopt the previously announced merger agreement under which Pfizer will acquire Seagen for $229 per share in cash.

Anika Therapeutics, Inc. (NASDAQ: ANIK), a global joint preservation company focused on early intervention orthopedics, today announced that it has completed enrollment of the pivotal Phase III clinical study for Hyalofast (Hyalofast 15-01) on its path to achieving FDA approval in the United States.

Miromatrix Medical Inc. (NASDAQ: MIRO), a life sciences company pioneering a novel technology for bioengineering fully transplantable organs to help save and improve patients’ lives, announced that members of the management team will participate in the upcoming 20th Annual Craig-Hallum Institutional Investor Conference on May 31st, 2023.