FDA - Spark Newswire

1 minute read

Cognition Therapeutics Has Received A Notice Of Allowance For Its U.S. Patent Application 16/783,943 Titled “Isoindoline Compositions And Methods For Treating Neurodegenerative Disease (Including Alzheimer’s Disease)”.

By Happy Mohamed

Today, 2:06 PM

https://patentcenter.uspto.gov/#!/applications/16783943/ifw/docs

CGTX

3 minute read

PharmaTher Holdings Nabs New Orphan Drug Status, Discusses Further Fast-Track, Partners For MDMA Patch

By Lara Goldstein

Today, 2:06 PM

Ketamine products manufacturer PharmaTher Holdings Ltd. (OTCQB: PHRRF) had lots happening this past week. Here are the company's top three news items.

PHRRF

1 minute read

Gilead Sciences’ Trovelvy Scores FDA Approval For Advanced/Metastatic Breast Cancer Setting

By Vandana Singh

Today, 2:06 PM

The FDA has approved Gilead Sciences Inc’s (NASDAQ:GILD) Trodelvy (sacituzumab govitecan-hziy) for adult patients with advanced or metastatic breast cancer. The…

GILD

1 minute read

The PTAB Denies United Therapeutics Request For A Rehearing Of The $UTHR ‘793 Patent Invalidation Decision

By Happy Mohamed

Today, 2:06 PM

https://ptacts.uspto.gov/ptacts/public-informations/petitions/1545682/download-documents?artifactId=170521156

LQDA

2 minute read

Attorney Generals Of Several States Warn CVS, Walgreens Against Mailing Abortion Medication

By Vandana Singh

Today, 2:06 PM

Republican attorneys general in 20 states warned CVS Health Corp (NYSE: CVS) and Walgreens Boots Alliance Inc (NASDAQ: WBA) against mailing abortion pills in their jurisdictions.

CVS

1 minute read

Cyngn Has Received A Notice Of Allowance For Its U.S. Patent Application 17/453,457 Titled “Obstacle Detection Systems (For Autonomous Vehicles Using Lidar And Camera Sensors)”

By Happy Mohamed

Today, 2:06 PM

https://patentcenter.uspto.gov/#!/applications/17453457/ifw/docs

CYN

1 minute read

SiNtx Technologies Has Received A Notice Of Allowance For Its U.S. Patent Application 17/156,188 Titled “Antifungal Composites And Methods Thereof”

By Happy Mohamed

Today, 2:06 PM

https://patentcenter.uspto.gov/#!/applications/17156188/ifw/docs

SINT

1 minute read

FDA
News

XORTX Announced Submission of Orphan Drug Designation Request for XRx-008 Program to Treat Autosomal Dominant Kidney Disease

By Charles Gross

Today, 2:06 PM

- XORTX Therapeutics Inc.

TSXV:XRTX

5 minute read

Mesoblast Says Resumbits Biologic License Application To FDA For Remestemcel-L In Children With With Steroid-Refractory Acute Graft Versus Host Disease (Sr-aGVHD)

By Michael Horton

Today, 2:06 PM

Validation of Remestemcel-L Potency Assay used in the Phase 3 Trial which Measures In-Vivo Activity based on Mechanism of Action Assay Identifies High-Potency Product Lots Associated with Enhanced Survival New Data Show that Remestemcel-L Improves Inflammatory Biomarkers and Survival in Children at Highest Risk of Mortality

MESO

5 minute read

February PDUFA Catalysts Biotech Investors Must Know: Sanofi’s Bleeding Disorder Drug, Regeneron’s Twin Eylea Label Expansions, 3 Delayed Approvals And More

By Shanthi Rexaline

Today, 2:06 PM

The year has started well for biopharma companies on the regulatory front, as most decisions handed out during January were positive. The Food and Drug Administration has already cleared four new molecular entities for the year.

APLS