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FDA approves Xolair as first and only medicine for children and adults with one or more food allergies

February 18th, 2024 2:41 am

Basel, 16 February 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy. People taking Xolair for food allergies should continue to avoid all foods they are allergic to (commonly referred to as “food allergen avoidance”). Xolair should not be used for the emergency treatment of any allergic reactions, including anaphylaxis. Immunoglobulin E (IgE)-mediated food allergies are the most common type and are typically characterised by the rapid onset of symptoms following exposure to certain food allergens.3 Xolair is the first and only FDA-approved medicine to reduce allergic reactions in people with one or more food allergies. Xolair is widely available and can now be prescribed for appropriate patients with IgE-mediated food allergy in the U.S.

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FDA approves Xolair as first and only medicine for children and adults with one or more food allergies

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Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

February 18th, 2024 2:41 am

AMTAGVI is the first FDA-approved T cell therapy for a solid tumor cancer and first treatment option for advanced melanoma after anti-PD-1 and targeted therapy

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Iovance’s AMTAGVI™ (lifileucel) Receives U.S. FDA Accelerated Approval for Advanced Melanoma

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Iovance Biotherapeutics to Host Conference Call and Webcast on Friday, February 16, 2024

February 18th, 2024 2:41 am

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, will host a conference call and live audio webcast to discuss the FDA approval announced earlier today at 4:15 p.m. ET, February 16, 2024.

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Iovance Biotherapeutics to Host Conference Call and Webcast on Friday, February 16, 2024

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Lifecore Biomedical, Inc. Announces Receipt of Nasdaq Notice of Delisting and Intention to Appeal

February 18th, 2024 2:41 am

Notice of Delisting Will Not Immediately Result in the Suspension or Delisting of the Company’s Securities Notice of Delisting Will Not Immediately Result in the Suspension or Delisting of the Company’s Securities

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Lifecore Biomedical, Inc. Announces Receipt of Nasdaq Notice of Delisting and Intention to Appeal

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Motus GI Holdings, Inc. Announces Adjournment of the February 16, 2024 Special Meeting of Stockholders

February 18th, 2024 2:41 am

FORT LAUDERDALE, Fla., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc. (“the Company”) (NASDAQ: MOTS), today announced that its special meeting of stockholders held on February 16, 2024 (the “Special Meeting”) was convened and then adjourned, without conducting any business, in order to provide stockholders additional time within which to vote on the proposal described in the Company’s definitive proxy statement filed with the Securities and Exchange Commission (the “SEC”) on January 24, 2024 (the “Proxy Statement”).

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Motus GI Holdings, Inc. Announces Adjournment of the February 16, 2024 Special Meeting of Stockholders

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Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

February 18th, 2024 2:41 am

SAN CARLOS, Calif., Feb. 16, 2024 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) ("Iovance" or the “Company”), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that on February 15, 2024 (the “Date of Grant”), the Company approved the grant of inducement stock options covering an aggregate of 40,450 shares of Iovance’s common stock to sixteen new non-executive employees.

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Iovance Biotherapeutics Reports Inducement Grants under NASDAQ Listing Rule 5635(c)(4)

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Where Does SpringWorks Therapeutics Inc (SWTX) Stock Fall in the Biotechnology Field After It Has Gained 12.41% This Week? – InvestorsObserver

February 18th, 2024 2:37 am

Where Does SpringWorks Therapeutics Inc (SWTX) Stock Fall in the Biotechnology Field After It Has Gained 12.41% This Week?  InvestorsObserver

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Where Does SpringWorks Therapeutics Inc (SWTX) Stock Fall in the Biotechnology Field After It Has Gained 12.41% This Week? - InvestorsObserver

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Where Does Candel Therapeutics Inc (CADL) Stock Fall in the Biotechnology Field After It Has Gained 22.38% This Week? – InvestorsObserver

February 18th, 2024 2:37 am

Where Does Candel Therapeutics Inc (CADL) Stock Fall in the Biotechnology Field After It Has Gained 22.38% This Week?  InvestorsObserver

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Where Does Candel Therapeutics Inc (CADL) Stock Fall in the Biotechnology Field After It Has Gained 22.38% This Week? - InvestorsObserver

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Should Biotechnology Stock Axsome Therapeutics Inc (AXSM) Be in Your Portfolio Wednesday? – InvestorsObserver

February 18th, 2024 2:37 am

Should Biotechnology Stock Axsome Therapeutics Inc (AXSM) Be in Your Portfolio Wednesday?  InvestorsObserver

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Should Biotechnology Stock Axsome Therapeutics Inc (AXSM) Be in Your Portfolio Wednesday? - InvestorsObserver

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Regenerative medicine | NIST

February 10th, 2024 2:33 am

Regenerative medicine therapy, including cell therapy, gene therapy, and therapeutic tissue engineering, provides unprecedented potential to treat, modify, reverse, or cure previously intractable diseases, such as cancer and organ failures. This class of therapy has completely changed the paradigm and the trajectory for medical treatment. Broad clinical translation and patient access requires advances in manufacturing technologies and measurements to ensure the safety, quality, and consistency of the therapy and to reduce the cost.

NIST is committed to solving the measurement challenges of this fast-moving sector of the bioeconomy by providing underpinning measurement infrastructure and platform technologies, as well as standards to promote manufacturing innovation, improve supply chain resilience, and support characterization and testing to facilitate regulatory approval.

The NIST Regenerative Medicine program is working closely with the U.S. Food and Drug Administration'sCenter for Biologics Evaluation and Research(FDA/CBER) and the Standards Coordinating Body (SCB) as well as the broader industry to develop global manufacturing and measurement standards underpinned by a robust measurement infrastructure needed to advance product development and translation as directed by Sec. 3036 of the 21st Century Cures Act.

The NIST laboratory programs support this growing industry as well as the broader industry ecosystem by:

NIST has developed a suite of standards and tools for characterizing biological systems and components using advanced measurement science strategies that enable the generation of high-quality data. Some recent examples of NISTs work include:

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Regenerative medicine | NIST

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Ophthalmologists Near Me in Hollywood, FL | Healthgrades

February 2nd, 2024 2:37 am

Anoptometristis a healthcare provider who specializes in routine and preventive eye and vision care. Optometrists diagnose vision abnormalities and prescribe eyeglasses and contacts. They detect and treat cataracts, glaucoma, and eye infections. Optometrists also screen for conditions that affect the eyes and vision, includinghigh blood pressureand diabetes.

An optometrist typically:

Evaluates a patients medical and vision history

Educates the patient about eye and vision disease prevention and health

Performs a comprehensive eye and vision exam and evaluates blood pressure

Performs and interprets specialized eye tests

Diagnoses and often treats acute and chronic eye diseases and conditions that affect vision, including eye injuries, vision problems, cataracts, and glaucoma

Screens for conditions that increase the risk of eye and vision conditions including diabetes and high blood pressure

Prescribes eye glasses, contacts, and certain medications

Refers patients to an ophthalmologist for serious eye problems and most eye surgeries

Performs laser or glaucoma surgeries in some cases

Provides eye and vision care before and after eye surgery

An optometrist may also be known by the following names:eye doctor, vision care specialist, and Doctor of Optometry (OD).

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Ophthalmologists Near Me in Hollywood, FL | Healthgrades

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CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody® Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a…

January 25th, 2024 2:42 am

- Initiation of CX-2051 Phase 1 clinical study in EpCAM positive tumors including colorectal cancer anticipated in 1H 2024 -

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CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody® Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a...

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Soleno Therapeutics Strengthens Leadership Team with Key Appointments

January 25th, 2024 2:42 am

REDWOOD CITY, Calif., Jan. 24, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced the appointments of Meredith Manning, M.B.A as Chief Commercial Officer, Dairine Dempsey, Ph.D. as Vice President, Europe and Lauren Budesheim, M.S. as Vice President of Human Resources. The Company also announced the appointment of key advisors with Shamim Ruff, M.S. joining as Chair of the Development Advisory Board and James (Jim) Geraghty, J.D., M.S. as a Board Advisor.

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Soleno Therapeutics Strengthens Leadership Team with Key Appointments

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nmible partners with Velocity Clinical Research to streamline clinical trials patient stipends

January 25th, 2024 2:42 am

•  nmible’s solution expected to save more than 650 working days per year, administering payments

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nmible partners with Velocity Clinical Research to streamline clinical trials patient stipends

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Evaxion to Develop Tailored Novel Cancer Vaccines Based upon a New Untapped Source of AI-Discovered Targets

January 25th, 2024 2:42 am

COPENHAGEN, Denmark, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, announces an expanded commitment to developing tailored cancer vaccines by targeting a novel category of AI-identified tumor antigens, named Endogenous Retroviruses (ERVs).

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Evaxion to Develop Tailored Novel Cancer Vaccines Based upon a New Untapped Source of AI-Discovered Targets

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Immix Biopharma Statement On January 2024 FDA Labeling Change Notification For Approved CAR-T Products

January 25th, 2024 2:42 am

LOS ANGELES, CA, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“Immix Biopharma”, “Company”, “We” or “Us”, Nasdaq:IMMX), a clinical-stage biopharmaceutical company trailblazing cell therapies in autoimmune disease, today announced a statement on January 2024, FDA labeling change notifications for approved CAR-T products:

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Immix Biopharma Statement On January 2024 FDA Labeling Change Notification For Approved CAR-T Products

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Altamira Therapeutics Files Second Provisional Patent Application for OligoPhore Nanoparticles Targeting Different KRAS Mutations in Cancer Treatment

January 25th, 2024 2:42 am

HAMILTON, BERMUDA, Jan. 24, 2024 (GLOBE NEWSWIRE) -- HAMILTON, BERMUDA, Jan. 24, 2024 -- Altamira Therapeutics Ltd. (Nasdaq: CYTO) ("Altamira" or the "Company"), a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets, today announced that it has filed a second provisional patent application with the United States Patent and Trade Office (USPTO) to provide broad coverage of different KRAS mutations in human cancer treatment with nanoparticles comprising the Company’s OligoPhore™ platform and a single siRNA sequence, polyKRASmut. The nanoparticles are developed by Altamira as AM-401.

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Altamira Therapeutics Files Second Provisional Patent Application for OligoPhore Nanoparticles Targeting Different KRAS Mutations in Cancer Treatment

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AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced…

January 25th, 2024 2:42 am

Subject enrollment is expected in Q1 2024 Subject enrollment is expected in Q1 2024

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AIM ImmunoTech Receives Erasmus Medical Center Ethics Board Authorization for Phase 2 Study of Ampligen® for the Treatment of Locally Advanced...

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Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine…

January 25th, 2024 2:42 am

-Project NextGen Collaboration will Support Capricor’s StealthX™ Exosome Platform and Provide Non-Dilutive Support for Advancement into the Clinic-

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Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine...

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PharmAla receives new “MDXXF” ticker from FINRA for OTCQB Listing

January 25th, 2024 2:42 am

New ticker symbol goes into effect immediately New ticker symbol goes into effect immediately   

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PharmAla receives new “MDXXF” ticker from FINRA for OTCQB Listing

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