U.S. Food and Drug Administration– tag –
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U.S. FDA Approves Pfizer and BioNTech’s XFG-Adapted COVID-19 Vaccine, Aligned with 2026 Fall Vaccination Guidance
Pfizer USA Overview Pfizer and BioNTech have received U.S. FDA approval for their XFG-adapted COVID-19 vaccine. This approval aligns with the FDA's guidance on the recommended composition for COVID-19 vaccines to be used in the United St... -
NJ Cancer Care Offers New Hope for Refractory Cancer Patients with Bispecific Antibody Therapy
NJ Cancer Care USA Overview NJ Cancer Care highlights bispecific antibody therapy as a groundbreaking treatment utilizing the patient's immune system to target and destroy cancer cells, offering new hope for those unresponsive to standar... -
Eli Lilly’s Oral GLP-1 Agonist ‘Foundayo (orforglipron)’ Receives FDA Approval for Obesity and Overweight Treatment
Drugs.com USA Overview Eli Lilly's Foundayo (orforglipron), a once-daily oral GLP-1 receptor agonist, has received FDA approval for adults with obesity or certain weight-related conditions. This small-molecule, non-peptide GLP-1 receptor... -
FDA Grants Fast Track Designation to Erasca’s Oral Pan-RAS Molecular Glue ERAS-0015 for Metastatic Pancreatic Adenocarcinoma
OncLive USA Overview Erasca's oral pan-RAS molecular glue, ERAS-0015, has received FDA Fast Track Designation for metastatic pancreatic adenocarcinoma. The drug demonstrated promising initial activity in a Phase 1 study for KRAS G12-muta... -
siRNA Therapy Successfully Switches Off Harmful Genes: FDA-Approved Patisiran and Other Drugs for Hereditary Amyloidosis
Works in Progress Magazine UK Overview siRNA therapy is emerging as a promising treatment to slow or halt disease progression by temporarily silencing specific genes. For conditions like hereditary transthyretin amyloidosis, FDA-approved... -
Bispecific Antibodies Revolutionize Cancer Therapy: 15 FDA-Approved, Over 600 in Clinical Trials as T-Cell Engagers
BroadPharm USA Overview Bispecific antibodies (BsAbs) are engineered to simultaneously bind two different antigens or epitopes, offering superior disease target recognition and biological effect modulation compared to conventional monocl... -
FDA Grants Breakthrough Therapy and Fast Track Designations to Norroy Bioscience’s 68Ga-NYM096 for Clear Cell Renal Cell Carcinoma PET Imaging, First Chinese-Origin Radiopharmaceutical to Receive BTD
Targeted Oncology USA Overview The U.S. FDA has granted Breakthrough Therapy Designation (BTD) and Fast Track Designation (FTD) to Norroy Bioscience's investigational PET imaging agent, 68Ga-NYM096, for detecting clear cell renal cell ca... -
FDA Approves Novo Nordisk’s Pasatru for FOP, Accelerates Approval for Tudriqev Combination in Melanoma, and Greenlights mFLUSIVA mRNA Flu Vaccine
Drugs.com USA Overview In August 2026, the FDA approved several key new drugs. Novo Nordisk's Pasatru (garetosmab-grts) gained approval for adults with Fibrodysplasia Ossificans Progressiva (FOP). An accelerated approval was granted for ... -
Unicorn Bioscience Report: Exosome Therapy Market Valued at $58.1 Billion Despite No FDA Approvals, 240 Clinical Trials Underway
Unicorn Bioscience Unknown Overview This article provides an overview of a market research report published by Unicorn Bioscience. As of 2026, the global therapeutic exosome market is valued at $58.1 billion, a paradoxical valuation give... -
FDA Grants Accelerated Approval to BMS’s Zenbexus for Multiple Myeloma in Combination with Daratumumab
U.S. Food and Drug Administration (FDA) USA Overview The U.S. FDA has granted accelerated approval to Bristol Myers Squibb's (BMS) Zenbexus (iberdomide), a novel CELMoD (cereblon E3 ligase modulator), for the treatment of multiple myelom...
