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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...

In Afghanistan, WHO and UNICEF will launch a polio vaccination campaign utilizing the PharmaJet® Tropis® ID delivery system

PharmaJet®, a company that strives to improve the performance and outcomes of injectables with its enabling needle-free injection technology, announced that the WHO prequalified Tropis ID delivery system will be used to support a polio eradication...

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...

Boehringer Ingelheim and the Lung Cancer Research Foundation Announce New Research Collaboration

The Lung Cancer Research Foundation (LCRF) announces a new research collaboration with Boehringer Ingelheim creating two funding mechanisms designed to address HER2 mutations in lung cancer: a new Team Science Award and an Early Career...

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...

Samsung Bioepis and Organon’s HADLIMA™ Gains FDA Interchangeability Designation, Expanding Access to Adalimumab Alternative

Samsung Bioepis Co., Ltd. and Organon & Co. announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration...

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,...

At the Longhorn Vaccines and Diagnostics Presents Compelling Data on the LHNVD-303 Vaccine for Sepsis Linked to Bacterial Infections

Longhorn Vaccines and Diagnostics, a One Health company developing vaccines and diagnostic tools for global public health and zoonosis concerns, presented new data on LHNVD-303, the company's composite peptide vaccine for sepsis due to bacterial...

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...

Beacon Therapeutics has been granted FDA Regenerative Medicine Advanced Therapy (RMAT) designation for laru-zova (AGTC-501)

Beacon Therapeutics Holdings Limited a leading ophthalmic gene therapy company with a mission to save and restore the vision of patients with blinding retinal diseases, announced that the U.S. Food and Drug Administration (FDA) has granted...

Pilatus Biosciences Inc. earns FDA Orphan Drug Designation for PLT012, targeting liver and intrahepatic bile duct cancer

Pilatus Biosciences Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its leading molecule, PLT012, for treating liver and intrahepatic bile duct cancer (HCC/ICCA). Achieved in November...

UroMems Appoints Former Axonics Executive Rinda Sama to Board of Directors

UroMems, a global medical technology company developing the first smart automated implant to treat stress urinary incontinence (SUI), today announced the appointment of medical device veteran Rinda Sama to its board of directors. "We are thrilled...

Leqembi® approved in Mexico

BioArctic AB's partner Eisai announced that the Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) in Mexico has approved Leqembi (lecanemab) for the treatment of early Alzheimer's disease (AD)1. Leqembi selectively binds to...

SciTech Development reveals promising Phase 1A trial results for T-cell non-Hodgkin lymphoma therapy

SciTech Development, a clinical-stage pharmaceutical company focused on advancements in cancer treatment, is excited to share promising updates from its clinical trial of ST-001 nanoFenretinide (ST-001). Preliminary Trial Findings: Preliminary...

AISA Pharma receives FDA orphan drug designation for AISA-021, a treatment for systemic sclerosis

Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AISA-021(cilnidipine), a fourth-generation calcium channel antagonist. Aisa is...

Gilead’s Livdelzi (Seladelpar) receives FDA accelerated approval for primary biliary cholangitis

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Livdelzi® (seladelpar) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in...

Citius Pharmaceuticals' LYMPHIR™ wins FDA approval for relapsed/refractory cutaneous T-cell lymphoma

Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior...

Cytonics Begins First-In-Human Phase 1 Clinical Study for CYT-108 in Osteoarthritis Knee Patients

Cytonics Corporation, a private biotechnology company developing biologic therapies for musculoskeletal ailments, announced initiation of enrollment for its Phase 1 clinical study of CYT-108. A recombinant variant of the alpha-2-macroglobulin...

CalciMedica Announces Positive Topline Data from Phase 2b CARPO Trial of Auxora™ in Acute Pancreatitis

CalciMedica Inc. a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic illnesses, announced positive topline...

Lykos Therapeutics Provides Update on FDA Advisory Committee Meeting for Investigational MDMA-Assisted PTSD Therapy

Lykos Therapeutics ("Lykos"), a company dedicated to transforming mental healthcare, announced the outcome of the U.S. Food and Drug Administration's ("FDA") Psychopharmacologic Drugs Advisory Committee ("PDAC"), which discussed the Company's new...

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