Category Press Releases

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…

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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…

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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

FDA Approves Merck’s KEYTRUDA® Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemoradiotherapy (CRT) for the treatment of patients with FIGO…

Read MoreFDA Approves Merck’s KEYTRUDA® Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer