FDA Newswatch Today's News
AxioMed LLC Submits Final Module III to the FDA Becoming the First and Only Lumbar Viscoelastic Total Disc Replacement Company to Complete a USA IDE Clinical Trial
08 Aug 2022 22:17:44 UT
On August 8, 2022, AxioMed LLC submitted to the FDA all the required documents for Module III. This is the final Module containing all the data tables comparing AxioMed to the Prodisc as the control....
FDA Delays Enforcement of UDI Reporting Requirements for Consumer Health Products
08 Aug 2022 21:36:06 UT
With a September 24, 2022 compliance date looming, the U.S. Food and Drug Administration (FDA) announced that will delay enforcement of its requirement to submit Unique Device Identifier (UDI) data...
FDA Approves sNDA for Nubeqa With Docetaxel to Treat Hormone-Sensitive Prostate Cancer
08 Aug 2022 20:49:22 UT
The approval is based on results of the phase 3 study, ARASENS, that demonstrated a statistically significant increase in overall survival, the trial’s primary endpoint. The FDA has approved a...
FDA Approves Acalabrutinib Tablet Formulation for All Approved Indications
08 Aug 2022 20:14:37 UT
Based on overall response rate, acalabrutinib in tablet form is now FDA approved for all approved indications, enabling co-administration alongside a proton pump inhibitor. The FDA granted...
FDA Clears AI Software for MRI-Based Prostate Diagnosis
08 Aug 2022 20:03:40 UT
Bot Image announced the FDA has cleared the company’s artificial intelligence (AI) driven medical device CAD software designed to improve the accuracy and speed of prostate cancer detection (CADe)...
FDA OKs Juvéderm Volux XC to Improve Jawline Definition
08 Aug 2022 18:30:01 UT
Allergan Aesthetics, an AbbVie company, announces the U.S. FDA approval of Juvéderm Volux™ XC for the improvement of jawline definition in adults over the age of 21 with moderate to severe loss of...
FDA Approves Intravenous Fam-Trastuzumab Deruxtecan-Nxki for Human Epidermal Growth Factor Receptor 2-Low Breast Cancer
08 Aug 2022 18:46:58 UT
The Food and Drug Administration (FDA) granted approval to fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody and topoisomerase inhibitor conjugate to be administered intravenously, to treat...
USPTO Underscores Duty of Disclosure Pertaining To FDA Submissions
08 Aug 2022 18:10:06 UT
Article By The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability...
Brand Institute Partners on Brand Name Development for FDA Approved Treatment to Help Retinal Disease Patients Maintain or Gain Vision
08 Aug 2022 17:24:06 UT
This Week at FDA: EtO, user fee woes, and product specific guidances
05 Aug 2022 20:24:21 UT
Regulatory NewsThis Week at FDA | 05 August 2022 | By Ferdous Al-Faruque  2842 Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and...
FDA announces website for complex generics
05 Aug 2022 19:27:54 UT
2860 The US Food and Drug Administration (FDA) just launched a new webpage to share recent actions and activities related to complex generic drugs to spur their development.   “Since these products...
FDA Approves First Targeted Therapy for HER2-Low Breast Cancer
05 Aug 2022 20:06:36 UT
FDA Approves Acalabrutinib Tablet Formulation in CLL/SLL and Relapsed/Refractory MCL
05 Aug 2022 16:00:42 UT
Acalabrutinib tablet formulation was approved by the FDA for patients with chronic lymphocytic leukemia/small lymphocytic leukemia and relapsed or refractory mantle cell lymphoma. Acalabrutinib...
FDA Grants Breakthrough Therapy Designation to Taletrectinib for ROS1+ Non–Small Cell Lung Cancer
05 Aug 2022 14:00:00 UT
Supported by data from an ongoing phase 2 trial, the ROS1 inhibitor taletrectinib was granted breakthrough therapy designation for the treatment of certain patients with advanced or metastatic...
FDA Approves Oral Darolutamide/Docetaxel for Metastatic HSPC
05 Aug 2022 17:20:31 UT
Patients with metastatic hormone-sensitive prostate cancer can now receive treatment with oral darolutamide plus docetaxel following its approval by the FDA. The FDA has granted approval to oral...
FDA Rejects Pimavanserin sNDA for Alzheimer Disease Psychosis
05 Aug 2022 16:15:00 UT
The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Acadia Pharmaceuticals regarding the supplemental New Drug Application (sNDA) for pimavanserin, for the treatment...
FDA Roundup: August 5, 2022
05 Aug 2022 17:48:58 UT
Anonymous (not verified) Fri, 08/05/2022 - 13:48 Short Title FDA Roundup: August 5, 2022 FDA Statement No Press Release Date August 05, 2022 Detailed Description The U.S. Food and Drug...
Cure: FDA approves tablet form of blood cancer treatment
05 Aug 2022 17:56:00 UT
Marker Therapeutics Announces FDA Clearance of IND for MT-601, the six-antigen targeted T Cell Therapy for the treatment of relapsed/refractory Non-Hodgkin Lymphoma
04 Aug 2022 21:48:53 UT
FDA considering dividing Jynneos doses into fifths to increase vaccine supply
04 Aug 2022 20:33:20 UT
A registered nurse prepares a dose of a Monkeypox vaccine. (AP Photo/Rick Bowmer) The Biden administration is considering splitting doses of the smallpox vaccine, which are being used to prevent...