| FDA Newswatch Today's News |
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| First oral diabetes treatment for cats receives FDA approval |
| 08 Dec 2022 20:46:21 UT |
| The bexagliflozin product (Bexacat; Increvet Inc) is also the first SGLT2 inhibitor new animal drug approved by the FDA in any animal species. Officials with the FDA have approved the first oral new... |
| Pharvaris Shares Surges On Positive Data From HAE Attacks Study, Makes Way For FDA To Remove Clinical Hold |
| 08 Dec 2022 18:15:43 UT |
| Pharvaris NV (NASDAQ: ) from the RAPIDe-1 Phase 2 study, demonstrating statistically significant results of PHVS416 as an oral on-demand treatment for hereditary angioedema (HAE) attacks. The... |
| FSIS and FDA Continue to Investigate Food-Borne Illnesses |
| 08 Dec 2022 19:39:48 UT |
| Article By The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Food and Drug Administration (FDA) continue to investigate and report recent food-related... |
| Lasik Surgery Should Carry Warnings of Possible Complications, FDA Says |
| 08 Dec 2022 00:00:00 UT |
| Latest Eyesight News By Cara Murez HealthDay Reporter THURSDAY, Dec. 8, 2022 (HealthDay News) – Lasik eye surgery is a common vision-correcting procedure that many Americans view as safe and... |
| Shineco granted US patent, FDA marketing approval for fecal specimen sampling device |
| 08 Dec 2022 19:47:26 UT |
| Shineco Inc. announced it has been granted a United States Patent and Trademark Office patent and FDA marketing approval for its in-situ fecal specimen sampling device intended for stool test sample... |
| Next-generation Dexcom G7 CGM receives FDA clearance for use in type 1 and type 2 diabetes |
| 08 Dec 2022 19:38:59 UT |
| The FDA has granted clearance to a next-generation continuous glucose monitoring system for people with all types of diabetes aged 2 years and older, according to a press release. Dexcom’s G7 CGM,... |
| FDA grants priority review for Pfizer’s RSV vaccine candidate for older adults |
| 08 Dec 2022 19:04:11 UT |
| The FDA has granted priority review to a biologics license application for Pfizer’s respiratory syncytial virus vaccine candidate, RSVpreF, for older adults, according to the company. “With no RSV... |
| FDA accepts NDA for intranasal epinephrine from ARS Pharmaceuticals |
| 08 Dec 2022 16:48:22 UT |
| neffy intranasal epinephrine. [Image from ARS Pharmaceuticals]ARS Pharmaceuticals announced today that the FDA accepted its new drug application (NDA) for neffy, its intranasal epinephrine. The... |
| Dewei Medical Equipment Co. Recalls DNA/RNA Preservation Kits That Are Not Authorized, Cleared, or Approved by the FDA |
| 08 Dec 2022 05:00:00 UT |
| The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Product Name: Dewei Medical Equipment... |
| Inhibikase Therapeutics Provides Update to FDA Clinical Hold of IkT-148009 Programs |
| 07 Dec 2022 21:14:55 UT |
| BOSTON and ATLANTA, Dec. 7, 2022 /PRNewswire/ -- Inhibikase Therapeutics, Inc. (Nasdaq: IKT) ("Inhibikase" or the "Company"), a clinical-stage pharmaceutical company developing protein kinase... |
| Imfinzi Receives New FDA Indication for Advanced or Metastatic Biliary Tract Cancer |
| 07 Dec 2022 05:00:00 UT |
| On September 2, 2022, the FDA accelerated the approval of durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, in combination with gemcitabine and cisplatin, for adults with locally advanced or... |
| Drug Products Labeled as Homeopathic Guidance for FDA Staff and Industry |
| 07 Dec 2022 16:44:49 UT |
| Docket Number: FDA-2017-D-6580 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance describes how we intend to... |
| FDA Collaborates with MITRE to update Medical Device Cybersecurity Playbook |
| 07 Dec 2022 19:11:06 UT |
| On November 14, 2022, under contract with the United States Food and Drug Administration (FDA), the MITRE Corporation (MITRE), an organization that administers the National Cybersecurity Center of... |
| FDA Grants Priority Review For Pfizer's RSV Vaccine |
| 07 Dec 2022 16:23:00 UT |
| The United States Food and Drug Administration has granted a priority review for Pfizer's respiratory syncytial virus (RSV) vaccine. Pfizer is seeking approval for its vaccine, RSVpreF, for adults... |
| FDA draft says Lasik patients should be wary of complications |
| 07 Dec 2022 17:21:18 UT |
| Patients considering LASIK surgery should be warned that they may experience double vision, dry eyes, difficulty driving at night and, in rare cases, persistent eye pain, according to draft guidance... |
| FDA draft guidance addresses complexities in establishing active ingredient sameness in an ANDA |
| 07 Dec 2022 17:12:35 UT |
| [co-author: Bryan Walsh, Deborah Cho] The U.S. Food and Drug Administration (FDA) recently published the draft guidance “Sameness Evaluations in an ANDA – Active Ingredients,” which aims to assist... |
| A Dubious Eye Cast on FDA Accelerated Approval |
| 07 Dec 2022 16:09:35 UT |
| It’s more than just a matter of time. I have discussed many times on Monitor Mondays the controversial Food and Drug Administration (FDA) accelerated approval of Aduhelm, the intravenous medication... |
| Report offers options for FDA food program reorganization |
| 07 Dec 2022 16:31:27 UT |
| The Food and Drug Administration Human Foods Program needs a single leader and a clear mission and vision to overcome recent problems including the unexpected shortage of infant formula, an outside... |
| Narcan maker says over-the-counter nasal spray fast-tracked by FDA |
| 06 Dec 2022 21:59:03 UT |
| Emergent BioSolutions Inc., the maker of narcotic overdose treatment Narcan, said on Tuesday that the Food and Drug Administration (FDA) has accepted its application to grant priority review of its... |
| Raj Chovatiya, MD, PhD: Psoriasis Treatment Developments, FDA Approvals in 2022 |
| 06 Dec 2022 22:15:17 UT |
| In an interview with HCPLive, Dr. Chovatiya spoke about recent FDA approvals for psoriasis treatments, including deucravacitinib, spesolimab, roflumilast, and tapinarof. During an interview with... |
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