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Building on a previous 2021 collaboration, Bristol Myers Squibb is paying $100 million upfront for the development of five cardiovascular targets utilizing Avidity Biosciences’ antibody oligonucleotide conjugates.
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The Dutch biotech’s stock dropped about 10% Tuesday morning after the company reported that its injectable Vyvgart Hytrulo missed the primary and secondary endpoints in an immune thrombocytopenia study.
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The biotech blames contract research organization Fortrea for incorrectly coding the dosing sequence in a psoriatic arthritis trial, which it contends resulted in some patients being given the wrong treatments.
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Aldeyra Therapeutics is planning to run another trial, in line with the regulator’s requirements, and is expecting top-line data and a New Drug Application resubmission in the first half of 2024.
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Advancements in asthma biologics spell future hope for patients with severe asthma.
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The Ogsiveo tablets are the first approval therapy for the rare subtype of soft tissue sarcomas, which can lead to severe pain and disability and previously were treated primarily through surgery.
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Follow along as BioSpace keeps you up-to-date on the latest pharma and biotech layoffs.
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Keep up with the regulator’s latest rulings on novel drugs and expanded indications, as the second half of 2023 promises some major milestone FDA approvals.
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Banjo Health and Opala Announce Strategic Partnership to Revolutionize Prior Authorization with AI and Interoperability
11/28/2023
Banjo Health, a leader in generative AI-powered prior authorization software, and Opala, an interoperability platform for seamless real-time data integration in healthcare, are excited to announce their strategic partnership.
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Ambrx Provides Update On APEX-01, an On-Going Phase 1 / 2 Dose Escalation Study Evaluating ARX517, a Proprietary PSMA-Targeting ADC, in Metastatic Castration-Resistant Prostate Cancer
11/28/2023
Ambrx Biopharma today announced a clinical update regarding its proprietary anti-PSMA antibody drug conjugate (ADC) ARX517 in the ongoing APEX-01 Phase 1 / 2 dose escalation and dose expansion clinical trial in metastatic castration-resistant prostate cancer (mCRPC).
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Escient Pharmaceuticals Initiates Clinical Proof-of-Concept Study of EP262, a First-in-Class Oral MRGPRX2 Antagonist, in Atopic Dermatitis
11/28/2023
Escient Pharmaceuticals, a clinical-stage drug development company advancing novel small molecule therapeutics for systemic neuro-immune disorders, today announced that the first subject has been dosed in EASE, a Phase 2a clinical proof-of-concept study of EP262 in subjects with atopic dermatitis (AD).
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Vaxcyte Appoints Jacks Lee to Board of Directors
11/28/2023
Vaxcyte, Inc. today announced the appointment of Jacks Lee to its Board of Directors.
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iCAD’s AI-powered solutions to Help Accelerate Breast Cancer Detection in New Collaboration with GE Healthcare
11/28/2023
iCAD, Inc. (NASDAQ: ICAD), a global medical technology leader in innovative cancer-detection solutions, today announced that key artificial intelligence (AI) powered solutions from iCAD’s ProFound Breast Health Suite are the first applications to be offered in GE HealthCare’s new MyBreastAI Suite* offering.
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Avidity Biosciences Announces Expansion of Cardiovascular Collaboration with Bristol Myers Squibb for up to Five Targets Utilizing Avidity's Proprietary AOC™ Platform Technology
11/28/2023
Avidity Biosciences, Inc. (Nasdaq: RNA) today announced a global licensing and research collaboration with Bristol Myers Squibb (NYSE: BMY) focused on the discovery, development and commercialization of multiple cardiovascular targets with potential cumulative payments of up to $2.3 billion.
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Femasys Inc. Completes Enrollment of FemaSeed Pivotal Trial in Support of Commercial Launch
11/28/2023
Femasys Inc. today announced completion of enrollment in the LOCAL FemaSeed® pivotal clinical trial, designed to evaluate women undergoing FemaSeed cycles due to male factor infertility.
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Immunovant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential
11/28/2023
Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults.
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Roivant Announces Positive IMVT-1402 Initial 600 mg MAD Results that Confirm Best-in-Class Potential
11/28/2023
Immunovant, Inc. (Nasdaq: IMVT), a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases, today announced initial data from 600 mg MAD cohort of a Phase 1 clinical trial of IMVT-1402 in healthy adults.
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The Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company’s Broad-Spectrum Antiviral Drug, Has Successfully Completed the First Part (Phase 1a), Reports NanoViricides
11/28/2023
NanoViricides, Inc. (NYSE American:NNVC) (the "Company"), a leader in the development of highly effective antiviral therapies based on a novel nanomedicines technology, reported today that the Single-Ascending Dose part of the Phase 1a/1b Human Clinical Trial of NV-CoV-2, the Company's broad-spectrum antiviral drug, was completed successfully.
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Anika Announces First Surgeries Performed using the Integrity™ Implant System, a Regenerative Hyaluronic Acid-Based Patch System for Rotator Cuff Repairs, Commencing Limited Market Release
11/28/2023
Anika Therapeutics, Inc. today announced that the first surgeries using the Integrity Implant System were successfully performed by Dr. Christopher Baker at the Florida Orthopaedic Institute in Tampa, FL.
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Derm-Biome Pharmaceuticals Announces Collaboration with Massachusetts General Hospital in Skin Cancer Study
11/28/2023
Derm-Biome Pharmaceuticals Inc is excited to announce that it is collaborating with Dr. Anna Mandinova from the Department of Dermatology at Massachusetts General Hospital in a skin cancer study.