Category Press Releases

Opdivo® in Combination with CABOMETYX® Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ: EXEL) today announced four-year follow-up results from the CheckMate -9ER trial evaluating Opdivo® (nivolumab) in combination with CABOMETYX® (cabozantinib) vs. sunitinib in patients with previously untreated advanced or metastatic renal cell carcinoma (RCC). Results continued to show…

Read MoreOpdivo® in Combination with CABOMETYX® Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma

Sanofi to acquire Inhibrx, Inc., adding potential best-in-class rare disease asset for Alpha-1 Antitrypsin Deficiency to pipeline

Sanofi and Inhibrx, Inc. (“Inhibrx”), a publicly traded clinical-stage biopharmaceutical company focused on developing a broad pipeline of novel biologic therapeutic candidates, have entered into a definitive agreement under which Sanofi has agreed to acquire Inhibrx following the spin-off of…

Read MoreSanofi to acquire Inhibrx, Inc., adding potential best-in-class rare disease asset for Alpha-1 Antitrypsin Deficiency to pipeline

WuXi Biologics Granted U.S. Patent for Proprietary Bispecific Antibody Technology Platform WuXiBodyTM

WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that a patent for WuXiBodyTM – a proprietary, highly flexible engineering platform that greatly enhances the developability characteristics of bispecifics – was granted by…

Read MoreWuXi Biologics Granted U.S. Patent for Proprietary Bispecific Antibody Technology Platform WuXiBodyTM

Bristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers

Bristol Myers Squibb (NYSE: BMY) today announced the presentation of data at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU) to be held from January 25-27 in San Francisco, California, highlighting the company’s progress in making long-term…

Read MoreBristol Myers Squibb Data at ASCO GU 2024 Showcase Transformative Research in the Treatment of Genitourinary Cancers

U.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy

Takeda today announced that the U.S. Food and Drug Administration (FDA) has approved HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent the relapse of neuromuscular…

Read MoreU.S. FDA Approves Takeda’s HYQVIA® as Maintenance Therapy in Adults with Chronic Inflammatory Demyelinating Polyneuropathy

European Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted marketing authorisation for Tecentriq® SC (atezolizumab), the European Union (EU)’s first PD-(L)1 cancer immunotherapy for subcutaneous (under the skin) injection. Last year, more than 38,000 people…

Read MoreEuropean Commission approves Roche’s Tecentriq SC, the EU’s first PD-(L)1 cancer immunotherapy subcutaneous injection for multiple cancer types

“LEQEMBI®” Approved for the Treatment of Alzheimer’s Disease in China

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, “Biogen”) announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody “LEQEMBI®” (brand name in China: “乐意保®”, generic…

Read More“LEQEMBI®” Approved for the Treatment of Alzheimer’s Disease in China

Nucala approved in China for use in severe asthma with an eosinophilic phenotype

GSK plc (LSE/NYSE: GSK) today announced that the China National Medical Products Administration has approved Nucala (mepolizumab), as an add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older. Nucala is the first anti-Interleukin-5 (IL-5) targeting treatment approved…

Read MoreNucala approved in China for use in severe asthma with an eosinophilic phenotype

Vertex Announces Approval of First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™, for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia in Kingdom of Saudi Arabia

 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the Saudi Food and Drug Authority (SFDA) granted Marketing Authorization for CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT). CASGEVY is approved…

Read MoreVertex Announces Approval of First CRISPR/Cas9 Gene-Edited Therapy, CASGEVY™, for the Treatment of Sickle Cell Disease and Transfusion-Dependent Beta Thalassemia in Kingdom of Saudi Arabia

TIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer

 Pfizer Inc. (NYSE: PFE) and Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) seeking to convert the accelerated approval of TIVDAK® (tisotumab vedotin-tftv) to full approval, for the treatment of…

Read MoreTIVDAK® Supplemental Biologics License Application Accepted for Priority Review by FDA for Patients with Recurrent or Metastatic Cervical Cancer