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The United States’ relatively high costs have become a political issue on both sides of the aisle. Here’s how international pharmaceutical prices stack up.
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The agency on Tuesday said it is investigating the “serious risk” of T cell malignancy outcomes, including hospitalization and death, and evaluating the need for potential regulatory action.
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FDA Cautions Public of Safety Issue with Philips' DreamStation 2 CPAP Machines
11/28/2023
As part of the U.S. Food and Drug Administration's continued commitment to protect and promote the public health, the agency is alerting patients and healthcare providers of an emerging safety issue involving Philips Respironics' DreamStation 2 Continuous Positive Airway Pressure machines used for treatment of obstructive sleep apnea.
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FDA Roundup: November 28, 2023
11/28/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Pfizer and BioNTech scored a win over Moderna on Tuesday as the European Patent Office decided that a key patent held by the Massachusetts biotech related to its COVID-19 vaccine is invalid.
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White House and Congress Propose AI Legislation as FDA Continues to Act as AI Regulatory Gatekeeper
11/22/2023
Both the White House and Congress have proposed legislation for the appropriate use of AI while the FDA continues to serve as the gatekeeper for patient privacy and safety. -
FDA Roundup: November 21, 2023
11/21/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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Diakonos Oncology Names Ian H. Bellayr, Ph.D. Chief Regulatory Officer
11/20/2023
Diakonos Oncology Corporation announced that Ian H. Bellayr, Ph.D., a regulatory expert with the U.S. Food and Drug Administration and National Institutes of Health, has joined the company as its Chief Regulatory Officer.
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FDA Roundup: November 17, 2023
11/17/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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ADMA BioCenters Receives FDA Approval for its Tenth Plasma Collection Center, Located in Laurel, MD FDA Approval Signifies the Accomplishment of ADMA’s Corporate Goal of Plasma Supply Self-Sufficiency
11/16/2023
ADMA Biologics, Inc. announced that it has received U.S. Food and Drug Administration approval for its tenth ADMA BioCenters plasma collection facility located in Laurel, Maryland.
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FDA Roundup: November 14, 2023
11/14/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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STADA and Alvotech receive positive CHMP opinion for Europe’s first ustekinumab biosimilar to Stelara
11/10/2023
Partners STADA and Alvotech announced that the Committee for Medicinal Products for Human Use within the European Medicines Agency has adopted a positive opinion for Uzpruvo, a biosimilar candidate to Stelara®.
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U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) for Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
11/9/2023
Bristol Myers Squibb announced that the U.S. Food and Drug Administration has accepted the supplemental Biologics License Application for Breyanzi to expand its current indication to include the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor.
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FDA Clears First COVID-19 Home Antigen Test
11/9/2023
The U.S. Food and Drug Administration cleared for marketing the first over-the-counter antigen test for COVID-19. ACON Laboratories' Flowflex COVID-19 Antigen Home Test, originally authorized for emergency use in 2021, is now the second home COVID-19 test to successfully complete a traditional FDA premarket review pathway, and the first indicated for use in children under 18.
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FDA Approves First Treatment for Patients with Rare Inherited Blood Clotting Disorder
11/9/2023
The U.S. Food and Drug Administration approved Adzynma, the first recombinant protein product indicated for prophylactic or on‑demand enzyme replacement therapy in adult and pediatric patients with congenital thrombotic thrombocytopenic purpura, a rare and life-threatening blood clotting disorder.
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Battelle Part of Team Selected to Support New Technologies to Prepare for Future COVID-19 Outbreaks
11/8/2023
As part of the federal $5 billion Project NextGen program, Battelle was awarded $6.1 million from the BARDA to advance human lung and airway tissue chip platform technology, also known as “organ on a chip.” The award is part of BARDA’s indefinite delivery/indefinite quantity contract with Battelle.
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The Department of Health and Human Services in a court filing last week said that the blockbuster treatment could be “deselected” from the drug price negotiation list, given the recent approval of Amgen’s Stelara biosimilar.
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Alucent Biomedical Receives Regulatory Approval for Second U.S. Clinical Study
11/7/2023
Alucent Biomedical Inc. announced that the U.S. Food & Drug Administration granted an Investigational Device Exemption for a U.S. clinical study of its AlucentNVS technology for promoting the maturation of arteriovenous fistulas in patients requiring hemodialysis.
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FDA Roundup: November 7, 2023
11/7/2023
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
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CMS Posts Proposed Medicare DMEPOS Fee Schedule Rate for the MyoPro® for Review at the Upcoming HCPCS Public Meeting
11/6/2023
Myomo, Inc. announced that the Centers for Medicare & Medicaid Services posted a proposed Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies fee schedule payment rate for the MyoPro® to be discussed at CMS’ bi-annual Healthcare Common Procedure Coding System Public Meeting, scheduled for November 29, 2023.