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Eisai submitted a rolling sBLA to the U.S. FDA for LEQEMBI® IQLIK™ as a subcutaneous starting dose to treat early Alzheimer’s, under Fast Track status

Eisai Co., Ltd. and Biogen Inc. announced that Eisai has initiated the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI®)...

Innovent Biologics announces U.S. FDA IND approval for Phase 3 MarsLight-11 study of IBI363 in squamous NSCLC

Innovent Biologics, Inc. a world-class biopharmaceutical company committed to developing, manufacturing and commercializing high-quality medicines in oncology, cardiovascular and metabolic diseases, autoimmune, ophthalmology and other major...

Theravance Biopharma completes enrollment in Phase 3 CYPRESS study of Ampreloxetine for neurogenic orthostatic hypotension

Theravance Biopharma, Inc. announced completion of enrollment in the open-label portion of its pivotal Phase 3 CYPRESS study in patients with symptomatic neurogenic orthostatic hypotension (nOH) due to multiple system atrophy (MSA), a rare and...

Abcentra LLC Commences Phase 2b 'FORTIFY' Trial with First Patient Dosed, Evaluating Orticumab for Cardiovascular Disease

Abcentra LLC, a clinical-stage biopharmaceutical company pioneering targeted therapies for cardiovascular inflammation, today announced the successful dosing of the first patient in its Phase 2b trial, FORTIFY, evaluating orticumab in patients...

Jazz Pharmaceuticals announces the U.S. FDA approval of Modeyso™ (dordaviprone) as the first and only treatment for recurrent H3 K27M-mutant diffuse midline glioma

Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Modeyso™ (dordaviprone) for the treatment of adult and pediatric patients 1 year of age and older with diffuse midline glioma...

Made Scientific and Sentinel BioTherapeutics Announce a Strategic Manufacturing Partnership to Advance the Phase I/II Allogeneic ePP Encapsulated Cell Therapy Program

Made Scientific, a leading U.S.-based cell therapy contract development and manufacturing organization (CDMO), and Sentinel BioTherapeutics, a clinical-stage biotechnology company advancing encapsulated cell-based immunotherapies for solid tumors,...

Phase 1/2 Clinical Study of Novel EGFR/HER3 Bispecific Antibody-Drug Conjugate AVZO-1418/DB-1418 Begins with First Patient Dosed

Duality Biotherapeutics' partner Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, announced the first patient has been dosed in the Phase 1 portion of a Phase 1/2 clinical...

Innovent Announces Approval from China's NMPA for Mazdutide, the First Dual GCG/GLP-1 Receptor Agonist, for Chronic Weight Management

Innovent Biologics, Inc. a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major...

enGene’s Detalimogene Receives RMAT Designation from the FDA, Opening the Path for Expedited Review in High-Risk, Non-Muscle Invasive Bladder Cancer

enGene Holdings Inc. a clinical-stage, non-viral gene-based immunotherapy company, announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to detalimogene voraplasmid (also...

Nuvation Bio’s IBTROZI™ (taletrectinib), a next-generation oral treatment for advanced ROS1-positive non-small cell lung cancer, has been approved by the U.S. Food and Drug Administration

Nuvation Bio Inc. a global oncology company focused on tackling some of the toughest challenges in cancer treatment, announced that the U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult...

Lubrizol reveals a significant milestone for its innovative, patented Apisolex™ polymer excipient

Lubrizol announces that an Apisolex™ polymer excipient-enabled drug formulation is in Phase 1 clinical trials. Introduced to the market in 2022, Apisolex polymer excipient is a polyamino acid-based polymer that enhances the solubility of BCS Class...

Otulfi® (ustekinumab-aauz) by Fresenius Kabi Now FDA-Approved as an Interchangeable Biosimilar

Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable biosimilar to the reference product Stelara® (ustekinumab)....

Rein Therapeutics announces the initiation of the RENEW Phase 2 trial of LTI-03 in patients with IPF

Rein Therapeutics a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, announced that the RENEW Phase 2 trial of its lead asset,...

Serge Messerlian Appointed CEO of Creyon Bio, Leveraging Decades of Experience in Company Building and Strategic Collaborations

Creyon Bio, Inc. announced the appointment of industry leader, Serge Messerlian as Chief Executive Officer, effective immediately. Mr. Messerlian brings Creyon Bio a track record in both multinational pharmaceutical and biotechnology leadership as...

HighField Biopharmaceuticals Files INDs for Two ADCplex™ Immunoliposomes with Distinct Payloads to Address Limitations of Current ADCs

HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer and other diseases, announced today it has filed two investigational new drug (IND) applications (HF158K1 and HFK2) with China’s National Medical...

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