Fake Ozempic – FDA and Novo Nordisk Warn Against Counterfeit Ozempic Penetrating US Market Amid High Demand
The FDA on Thursday said it continues to investigate counterfeit Novo Nordisk A/S's&n
New Hope for Nerve Damage Patients as AstraZeneca/Ionis’ Eplontersen Receives FDA Nod for Hereditary Amyloidosis Treatment
Friday, FDA approved AstraZeneca
FDA Refuses Neurology-Focused Clene’s Accelerated Approval For Amyotrophic Lateral Sclerosis Treatment, Shares Fall
Clene Inc (NASDAQ: CLNN) provided an amyotrophic lateral sclerosis (ALS) regulatory update from its recent meeting with the FDA to discuss CNM-Au8 for ALS, presenting initial clinical and Neurofilament Light Chain (NfL) biomarker results from the completed
New Hope In Cancer Battle: FDA Grants Breakthrough Device Status To Vivos Inc.’s RadioGel
In a significant advancement for cancer therapy, the Food and Drug Administration (FDA) has awarded RadioGel Precision Radionuclide Therapy the coveted Breakthrough Device Designation.
Why Is Complement-Mediated Focused Annexon Stock Trading Higher Today?
On Wednesday, Annexon Inc (NASDAQ: ANNX) reported results from the Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) healthy volunteer study of ANX1502 that targets the active form of C1s responsible for propagating classical pathway
Philips Recalls Medical Imaging Device Due To A Risk Of Explosion; FDA Identifies Recall As Most Serious Type
Koninklijke Philips N.V. (NYSE: PHG) has recalled some Panorama 1.0T HFO machines. The magnetic resonance (MR) system is used to take different kinds of images that show what's inside the body and can help health care providers make a diagnosis.
Calliditas Therapeutics Scores Complete FDA Approval, Broader Label For Lead Kidney Disease Drug
The FDA approved Calliditas Therapeutics AB's (NASDAQ: CALT) Tarpeyo (budesonide) delayed-release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) at
Merck’s Chronic Cough Treatment Candidate Receives Second Time FDA Rejection
The FDA issued a Complete Response Letter (CRL) regarding Merck & Co Inc's (NYSE: MRK) New Drug Application (NDA) for gefapixant under development for the treatment of refractory chronic cough (RCC) or unexplained chronic
Calliditas Therapeutics AB Announced That The FDA Approved TARPEYO Delayed Release Capsules To Reduce The Loss Of Kidney Function In Adults With Primary Immunoglobulin A Nephropathy At Risk For Disease Progression
TARPEYO (investigational name NEFECON) is the only FDA-approved treatment for IgAN to significantly reduce the loss of kidney function. TARPEYO is now
Blood-Based Colorectal Cancer CRC Screening Market Likely to Benefit From FDA’s Panel Surprise Advisory Possibility: Analyst
Tuesday, Guardant Health Inc (NASDAQ: GH) announced that the FDA's Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee is tentatively scheduled to review the premarket approval application (PMA) for its Shield blood test to screen for colorectal