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Following a months-long safety review, the regulator on Thursday said it is now requiring black box warnings for all commercially available CAR-T therapies to reflect the risk of secondary malignancies.
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Roche’s subsidiary Genentech has successfully expanded the label of Alecensa to include the adjuvant treatment of anaplastic lymphoma kinase-positive, early-stage non-small cell lung cancer following resection.
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French healthcare and pharma company Sanofi will terminate an undisclosed number of positions in its U.S. vaccines commercial unit in an effort to streamline the strategic sales structure.
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Fierce competition. Thin pipelines. Patent cliffs. The stakes are sky-high for pharmaceutical companies and investors alike.
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If a company’s final sales end up falling short of the consensus analyst estimate, then they have missed their number. Johnson & Johnson was close in the first quarter of 2024 but ultimately no cigar.
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Alvotech signs U.S. agreement to expand access for newly approved high-concentration interchangeable biosimilar to Humira® (adalimumab)
4/19/2024
Alvotech announced a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration approved high-concentration interchangeable biosimilar to Humira.
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Vaccinologists Keith Klugman and Shabir Madhi Awarded Sabin’s Prestigious Gold Medal; Infectious Diseases Epidemiologist Nicole Basta Receives Rising Star Award
4/19/2024
The Sabin Vaccine Institute yesterday presented the Albert B. Sabin Gold Medal to physician-researchers Keith Paul Klugman and Shabir Ahmed Madhi, and its Rising Star award to infectious diseases epidemiologist Nicole Elaine Basta at a ceremony in the National Academy of Sciences building in Washington D.C.
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Amarna Therapeutics announces appointment of Aurelia Caparrós as new Chief Business Officer
4/19/2024
Amarna Therapeutics, a privately-held biotechnology company developing transformative gene therapies in a range of rare and prevalent diseases, including Type 1 Diabetes Mellitus, announces the appointment of Aurelia Caparrós as the Company’s new Chief Business Officer, effective 1st of April 2024.
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ARTHEx Biotech Announces Oral Presentation on ATX-01 at the Oligonucleotide & Peptide Therapeutics (TIDES) Conference 2024
4/19/2024
ARTHEx Biotech S.L. announced an oral presentation at the upcoming Oligonucleotide & Peptide Therapeutics Conference 2024, being held in a hybrid format May 14-17, 2024 in Boston and online.
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ProQR Achieves Successful Defense of New Challenge to its Axiomer™ IP Portfolio
4/19/2024
ProQR Therapeutics N.V. today announced it has again successfully defended against opposition filed against a key patent for its ADAR-mediated RNA editing platform Axiomer™.
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Tiziana Life Sciences Announces Study Results from Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients with PIRA Highlighted in Neurology Today®
4/19/2024
Tiziana Life Sciences, Ltd. today announced that a study related to its lead candidate, foralumab, was highlighted in Neurology Today®, the official news source of the American Academy of Neurology (AAN), in an article titled, “Anti-CD3 Antibody Foralumab Shows Promise in PIRA, Measured by Novel PET Ligand.”
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GenFleet Therapeutics Announces FDA's Clinical Trial Approval for GFH925 (KRAS G12C Inhibitor) Monotherapy in Phase III Registrational Study Treating Metastatic Colorectal Cancer
4/19/2024
GenFleet Therapeutics announced US Food and Drug Administration (FDA) has granted the clinical trial approval for GFH925 (KRAS G12C inhibitor) in a multi-center, open-label, randomized and controlled phase III study treating refractory metastatic colorectal cancer (CRC) patients.
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YS Biopharma Announces Unaudited Financial Results for the First Nine Months of Fiscal Year 2024
4/19/2024
YS Biopharma Co., Ltd. today announced its unaudited consolidated financial results for the first nine months of the fiscal year ended March 31, 2024.
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Health Canada Approves KEYTRUDA as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma
4/19/2024
Merck announced that Health Canada has granted approval of KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with fluoropyrimidine- and platinum-containing-chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.
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Cresilon Announces Distribution Partnerships for VETIGEL with Leading Animal Health and Veterinary Product Suppliers
4/19/2024
Cresilon Inc. today announced it has entered into distribution agreements for its revolutionary hemostatic gel, VETIGEL®, to be sold directly to veterinary surgeons through several of the leading animal health and veterinary product suppliers in the U.S., including Covetrus, MWI Animal Health, and Patterson Veterinary Supply.
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Legacy Medical Consultants Announces Reeva FT™, a Full-Thickness Allograft for Wound Covering and Protection During Treatment
4/19/2024
Legacy Medical Consultants (LMC) announces its newest product portfolio addition with the recent Q code approval for Reeva FT™, a terminally sterilized, full-thickness, dual-layered amnion/chorion allograft designed for covering and protection during advanced wound treatment.
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La Jolla Institute for Immunology and RevolKa started a Research Collaboration
4/19/2024
RevolKa Ltd., a venture-backed biotech company providing a game-changing protein engineering technology platform and La Jolla Institute for Immunology agreed to start a research collaboration to create antigens for the next-generation vaccines to deliver innovative solutions to unmet medical need in infectious diseases.
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Antibe Provides Update on CCAA Proceedings
4/19/2024
Antibe Therapeutics Inc. (“ Antibe ” or the “ Company ”) (TSX: ATE) announced that the Company sought an extension of its previously announced stay of proceedings (“ Stay ”) under the Companies’ Creditors Arrangement Act (the “ CCAA ”) at a hearing before the Ontario Superior Court of Justice (Commercial List) (the “ Court ”) on April 18, 2024.
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Ensysce Biosciences' Presentation from the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference Published
4/19/2024
Ensysce Biosciences, Inc. today announced the Company's webcast presentation and discussion during the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference on April 17, 2024 is available on Ensysce's Investor Relations website at ir.ensysce.com and can also be viewed here.
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Sunshine Biopharma's Nora Pharma Receives Health Canada Approval for Niopeg(R), a Biosimilar of Neulasta(R)
4/19/2024
Sunshine Biopharma Inc. is happy to announce that its wholly owned generic pharmaceutical subsidiary, Nora Pharma, has received approval for its first Biosimilar product.