FDA Archives - Page 106 of 220

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Akebia Therapeutics Received Interim Response From The FDA To Appeal For Vadadustat For The Treatment Of Anemia Due To Chronic Kidney Disease

February 21, 8:33 AM

Akebia Therapeutics®, Inc. (NASDAQ:AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company received a second interim

AKBA

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FDA
News

Regeneron Says Pozelimab (C5 Antibody) BLA For Treatment Of Children And Adults With Ultra-rare CHAPLE Disease Accepted For FDA Priority Review

By Benzinga Newsdesk

February 21, 8:07 AM

Regeneron announced the U.S. Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for pozelimab as a treatment for adults and children as young as 1 year of age with

REGN

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The FDA Has Completed A Filing Review Of Valneva’s Biologics License Application For Its Single-shot Chikungunya Vaccine Candidate, VLA1553

By Benzinga Newsdesk

February 21, 5:10 AM

VLA1553 has been assigned a Prescription Drug User Fee Act (PDUFA) review goal date at the end of August 2023.

VALN

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Travere Therapeutics FILSPARI New Drug Application For Type 1 – New Molecular Entity Was Approved On 02/17/2023

By Happy Mohamed

February 17, 4:17 PM

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216403

TVTX

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Stryker’s Q Guidance System Scores FDA Clearance For Cranial Applications

By Vandana Singh

February 17, 12:27 PM

Stryker Corporation (NYSE:SYK) announced that its Q Guidance System with Cranial Guidance Software received FDA510(k) clearance. The Q Guidance System…

SYK

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ReShape Lifesciences Has Received A Notice Of Allowance For Its U.S. Patent Application 16/326,607 Titled “Gastric Vest For Restriction Of The Stomach To Treat Obesity”

By Happy Mohamed

February 17, 11:34 AM

https://patentcenter.uspto.gov/#!/applications/16326607/ifw/docs

RSLS

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Bristol Myers Squibb Announces Adjuvant Opdivo Continues To Provide Significant, Durable Clinical Benefits For Patients With Radically Resected, High-Risk Muscle-Invasive Urothelial Carcinoma After Three Years In CheckMate -274 Trial

By Happy Mohamed

February 17, 11:02 AM

Three-year median follow-up data demonstrate significantly improved disease-free survival, non-urothelial tract recurrence-free survival, distant metastasis-free survival and second progression-free survival with

BMY

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‘Maker Of Promising Alzheimer’s Drug Leqembi Expects Full FDA Approval This Summer, Expanded Medicare Coverage’ – CNBC

By Happy Mohamed

February 17, 10:52 AM

https://www.cnbc.com/2023/02/17/maker-of-promising-alzheimer-drug-leqembi-expects-fdas-full-approval-this-summer.html Eisai is anticipating full FDA approval of its early Alzheimer’s treatment, Leqembi, as soon

BIIB

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Trodelvy Demonstrates Efficacy Treating Both Platinum-Ineligible And Rapidly Progressing, Post-Platinum Metastatic Urothelial Cancer

By Happy Mohamed

February 17, 10:01 AM

– Oral Presentation Highlights Trodelvy Efficacy of 13.5 Months Overall Survival in Patients with Platinum-Ineligible Metastatic UC After Checkpoint Inhibitor Therapy – – Trodelvy Demonstrated

GILD

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Court of Appeals Affirms District Court Decision Invalidating Minerva Surgical Patent Asserted Against Hologic; The U.S. Court Of Appeals Rejected Minerva’s Arguments On Appeal And As A Result, Minerva Had To Pay Hologic More Than $7.4M

By Happy Mohamed

February 17, 9:09 AM

Hologic, Inc. (NASDAQ:HOLX) announced today that the U.S. Court of Appeals for the Federal Circuit unanimously affirmed a 2021 district court ruling that invalidated a Minerva patent asserted against Hologic. The

HOLX