AbbVie

Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...

Acoramidis Joins Bayer's Robust Lineup, Boosting Cardiology Solutions Bayer has obtained the exclusive rights to market acoramidis in Europe from Eidos Therapeutics Inc., BridgeBio International GmbH, and BridgeBio Europe B.V. Acoramidis, a highly potent and selective small molecule given orally, functions as a ...

Lutikizumab Showed Positive Results in a Phase II Trial of Adults with Moderate to Severe Hidradenitis Suppurativa as Program Advances to Phase III AbbVie has reported the results of Phase II trials indicating that adults experiencing moderate to severe hidradenitis suppurativa, and who had previously not respon...

FDA Grants Priority Review to Merck’s Application for KEYTRUDA Plus Padcev for the First-Line Treatment of Patients With Locally Advanced or Metastatic Urothelial Cancer Merck, operating as MSD internationally, reported that the U.S. Food and Drug Administration (FDA) has prioritized the review of a supplementar...

AbbVie Presents Results from Phase III CANOVA Study of Venetoclax in Patients with Relapsed or Refractory Multiple Myeloma AbbVie has released findings from its Phase III CANOVA trial, which assessed the safety and effectiveness of venetoclax (marketed as VENCLEXTA®/VENCLYXTO®) in combination with dexamethasone ...

Disc Medicine Receives FDA Fast Track Designation for MWTX-003 for the Treatment of Polycythemia Vera On Sept. 20, 2023, Disc Medicine, Inc. (NASDAQ: IRON) announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation to MWTX-003 for the treatment of patients with Polycyt...

Abbvie-Genmab’s EPKINLY, the first CD20XCD3 Bispecific Antibody gets US approval for Relapsed/Refractory DLBCL treatment. Roche’s Glofitamab is expected to garner benefits in Europe first. Let's have a glimpse of evolving DLBCL treatment landscape in Relapsed/Refractory setting and if bi-specific as a class can be...

FDA Approves RINVOQ as a Once-Daily Pill for Moderately to Severely Active Crohn's Disease AbbVie announced that the FDA had approved RINVOQ® (upadacitinib) for treating people with moderately to highly active Crohn's disease who have had an unsatisfactory response or intolerance to one or more TNF blockers. Thi...

AbbVie Announces Positive Results of Study Evaluating SKYRIZI in Plaque Psoriasis Patients AbbVie announced new 52-week data from an open-label, a single-arm study demonstrating improved plaque psoriasis signs and symptoms in a difficult-to-treat patient population who received SKYRIZI® (risankizumab), an IL-23 ...

FDA Approves Luye Pharma’s Rykindo for Schizophrenia Luye Pharma has received its first FDA approval for Rykindo, an injectable formulation of the antipsychotic risperidone administered every two weeks. Rykindo has been approved by the US Food and Drug Administration for the treatment of schizophrenia as well as...