FDA Newswatch Today's News
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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