FDA Archives - Page 126 of 220

1 minute read

Unicycive Issued Notice Of Acceptance To Initiate Phase 1 Study Of UNI-494 Following Review Of Clinical Trial Application By The Medicines And Healthcare Products Regulatory Agency In The United Kingdom

December 22, 8:02 AM

Unicycive Therapeutics, Inc. (NASDAQ:UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, announced today that the Medicines and Healthcare Products Regulatory Agency

UNCY

2 minute read

Rocket Pharmaceuticals Provides Update on Anticipated Registration Path for RP-A501 in Danon Disease Following End-of-Phase 1 FDA Meeting

By Charles Gross

December 22, 7:04 AM

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare childhood disorders with high unmet need, today announces updates from the Company's end-of-Phase 1 meeting with the U.S.

RCKT

9 minute read

FDA
News

PureTech Health Plc Provides Update On Progress Made Across Its Wholly Owned Programs And Founded Entities In 2022

By Benzinga Newsdesk

December 22, 5:42 AM

Rapid advancement of PureTech's Wholly Owned Pipeline, with three clinical trials now underway and five completed this year that demonstrated compelling safety and tolerability data for LYT-100 (deupirfenidone) and proof of principle, oral bioavailability and tolerability for LYT-300 (oral allopregnanolone).

AKLI

2 minute read

Alvotech Provides Update On U.S. Regulatory Status Of AVT02, Co’s Proposed High-Concentration, Interchangeable Biosimilar To Humira

By Benzinga Newsdesk

December 22, 5:37 AM

U.S. Food and Drug Administration (FDA) has confirmed that the goal date for an approval decision on Alvotech's license application for AVT02 is April 13, 2023 FDA has completed review of

ALVO

2 minute read

Reported Late Wednesday, Natera Supports Updated ISHLT Guidelines For The Care Of Heart Transplant Patients In The Journal Of Heart And Lung Transplantation

By Benzinga Newsdesk

December 22, 1:10 AM

Natera, Inc. (NASDAQ:NTRA), a global leader in cell-free DNA (cfDNA) testing, announced its support for a recent guideline update…

NTRA

1 minute read

Akero Therapeutics Completes Enrollment Of Phase 2b SYMMETRY Study And Announces Expected 2023 Milestones

By Benzinga Newsdesk

December 21, 5:01 PM

Results of the main study in patients with compensated cirrhosis due to NASH (F4) expected in fourth quarter of 2023 Results of the cohort D expansion to evaluate EFX in combination with GLP-1 therapy in patients with

AKRO

5 minute read

Vidprevtyn Beta Covid-19 Booster Vaccine, Developed By Sanofi And GSK, Approved For Use In Great Britain

By Benzinga Newsdesk

December 21, 12:11 PM

https://www.gsk.com/en-gb/media/press-releases/vidprevtyn-beta-covid-19-booster-vaccine-approved-for-use-in-great-britain/ SARS-CoV-2 spike protein (B.1.351 strain) vaccine is the first and only protein-based variant

GSK

3 minute read

Melt Pharmaceuticals’ MELT-300, Midazolam 3mg And Ketamine 50mg Sublingual Tablet, Achieves Top-Line Results In Primary Sedation Endpoint In Phase 2 Pivotal Efficacy And Safety Study

By Benzinga Newsdesk

December 21, 10:22 AM

MELT-300 Statistically Superior for Procedural Sedation Compared to All Comparator Treatment Arms, Including Midazolam 3mg (P=0.0129) and Ketamine 50mg (P=0.0096) MELT-300 Treatment Arm 50% Less Likely to Require Rescue Sedation Compared to Midazolam (P=0.0198)

HROW

1 minute read

AstraZeneca Announced Earlier Lynparza Approved in EU for Prostate Cancer; AstraZeneca to Receive $105M Milestone Payment from Merck

By Charles Gross

December 21, 5:49 AM

AstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated.

AZN

3 minute read

ADC Therapeutics And Sobi Announce European Commission Approval Of ZYNLONTA For The Treatment Of Relapsed Or Refractory Diffuse Large B-Cell Lymphoma; Approval Triggers $50M Milestone Payment To ADC Therapeutics

By Benzinga Newsdesk

December 21, 3:36 AM

Approval triggers $50 million milestone payment to ADC Therapeutics ADC Therapeutics SA (NYSE:ADCT) and Swedish Orphan Biovitrum AB (Sobi®) today announced the European Commission (EC) has granted

ADCT