Thursday, November 21, 2024

Thursday, November 21, 2024

Latest News

FDA Approves First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer

The U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

NOVARTIS: Announces FDA approval of Xolair® (omalizumab) for adults with nasal polyps

Xolair is the first biologic for the treatment of nasal polyps that targets and blocks immunoglobulin E (IgE), a key driver of inflammation

BLUEPRINT MEDICINES: Announces FDA Approval of GAVRETO™ (pralsetinib) for the Treatment of Patients with Advanced or Metastatic RET-Mutant and RET Fusion-Positive Thyroid Cancer

Once-daily treatment with GAVRETO demonstrated robust efficacy in patients with RET-altered thyroid cancers, including prolonged duration of response

Eurofins U.S. Clinical Diagnostic Laboratories Partner with Insurance Providers to Cover FDA-Authorized At-Home COVID-19 Test

Eurofins announces that its FDA-authorized At-Home COVID-19 Nasal PCR Test is now being covered by Medicare, Medicaid and commercial insurance providers.

CORVENT MEDICAL: Receives FDA Emergency Use Authorization Of Its Novel RESPOND-19™ Ventilator For Multiple Patient Use

CorVent Medical, a Coridea portfolio company focused on developing versatile, reusable, lifesaving ventilators, announced today that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for primary critical care use of the company's RESPOND-19™ Ventilator.

NATIONAL KIDNEY FOUNDATION: Hundreds of IgA Nephropathy Patients Share Experience with FDA, Professionals, Drug-makers

The National Kidney Foundation presents "Voice of the Patient Report: IgA Nephropathy" to federal agency

MICHAEL J. FOX FOUNDATION FOR PARKINSON'S RESEARCH: Honored with Advocacy/Policy Award from Reagan-Udall Foundation for the FDA

The Michael J. Fox Foundation for Parkinson's Research (MJFF) has received the Advocacy/Policy Award from the Reagan-Udall Foundation for the Food and Drug Administration.

OBLATO: Announces Discussion Outcome with FDA for Development of OKN-007 for Diffuse Intrinsic Pontine Glioma

Oblato, Inc. (the Company), a wholly owned U.S. subsidiary of the Korean biotech company GtreeBNT Co., Ltd., announced it had official discussions with the FDA on a detailed plan for a phase 1/2 clinical trial to start developing a new treatment for Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric disease, using its proprietary drug, OKN-007.

Pharmacy Organizations Welcome FDA Authorization of COVID Vaccine: "We Stand Ready to Serve"

The leaders of 18 pharmacy organizations today issued the following statement following the Food and Drug Administration's approval of the first Emergency use Authorization for the COVID-19 vaccine.

FDA Approves Novadoz Pharmaceuticals Toremifene and Aminocaproic Acid, Bolstering their Continued Growth in Generics

MSN Labs, based in Hyderabad India, recently received FDA approval to market their generic versions of Toremifene 60mg tablets, (AB rated to Kyowa Kirin's Fareston©) & Aminocaproic Acid 500mg tablet, (AB rated Clover's Amicar©) under the Novadoz label.

FDA: Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

Test is authorized for individuals two years of age or older, including those not showing symptoms

FDA: Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test

The U.S. Food and Drug Administration issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription.

FDA: Warns Consumers to Avoid Certain Male Enhancement and Weight Loss Products Sold Through Amazon, eBay and Other Retailers Due to Hidden, Potentially Dangerous Drug Ingredients

Agency Urges Online Marketplaces, Other Websites and Retailers to Stop Selling These Male Enhancement and Weight Loss Products to American Consumers

BLUEPRINT MEDICINES: Submits Supplemental New Drug Application to FDA for AYVAKIT™ (avapritinib) for the Treatment of Advanced Systemic Mastocytosis

Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for AYVAKIT™ (avapritinib) for the treatment of adult patients with advanced systemic mastocytosis (SM).

THERAPEUTIC SOLUTIONS INTERNATIONAL: Files Investigational New Drug Application (IND) with FDA for Treatment of Chronic Traumatic Encephalopathy Using Clinically Validated JadiCell® Universal Donor Stem Cell

Therapeutic Solutions International, Inc., (OTC Markets: TSOI), announced today filing of an Investigational New Drug (IND) application seeking permission from the Food and Drug Administration (FDA) to initiate a Phase I/II clinical trial assessing safety and signals of efficacy for treatment of Chronic Traumatic Encephalopathy (CTE) patients with JadiCells™.

FDA Health News