FDA Archives - Page 181 of 220

Follow-up data further demonstrate encouraging signs of clinical anti-tumor activity and a manageable safety and tolerability profile, building on the positive interim data presented at AACR in April Strongest

BNTX

1 minute read

U.S. FDA And European Medicines Agency Accepted Pfizer’s Hair Loss Candidate Submission For Review

By Ragothaman Srinivasan

September 9, 9:06 AM

The U.S. Food and Drug Administration (FDA) has accepted for review Pfizer’s (NYSE: PFE) New Drug Application (NDA) for ritlecitinib for adults and adolescents 12 years of age and older with alopecia areata. The regulatory agency is expected to make a decision in the second-quarter of 2023.

PFE

1 minute read

FDA Warns of Clip Lock Malfunctions With Abbott’s MitraClip Heart Valve Devices

By Vandana Singh

September 9, 6:23 AM

The FDA alerted healthcare providers about the potential for clip lock malfunctions with Abbott Laboratories (NYSE: ABT) MitraClip's delivery system to stop heart valve leakage.

ABT

4 minute read

Important Biotech Catalysts For September 8, 2022 – End Of The Day Summary

By Ragothaman Srinivasan

September 8, 6:17 PM

The United States Food and Drug Administration (FDA) has approved Revance Therapeutics’ (NASDAQ:RVNC) lead asset DAXXIFY (DaxibotulinumtoxinA-lanm) for…

ALNY

1 minute read

FDA
News

FDA Warns Of Potential Clip Lock Issue With Abbott’s Heart Valve Repair Device

By Benzinga Newsdesk

September 8, 4:25 PM

-Reuters

ABT

3 minute read

Intellia Therapeutics Announces Upcoming Investor Event To Present Interim Clinical Data From Ongoing First-In-Human Studies Of NTLA-2002 And NTLA-2001 On September 16

By Benzinga Newsdesk

September 8, 4:02 PM

Review of first clinical data from ongoing Phase 1/2 Study of NTLA-2002 for the treatment of hereditary angioedema (HAE) presented at the 2022 Bradykinin Symposium Event to include interim safety and serum TTR

NTLA

1 minute read

Regeneron Highlights Dupixent (dupilumab) Late-Breaking Phase 3 Data At The EADV 2022 Congress; Says Data Show Significant Improvements In Signs And Symptoms Of Prurigo Nodularis

By Benzinga Newsdesk

September 8, 11:30 AM

early three times as many Dupixent patients experienced clinically meaningful reductions in itch and skin lesions at 24 weeks compared to placebo There are currently no approved medicines specifically indicated to treat

REGN

2 minute read

Needham Gives Revance Therapeutics Buy Rating With Note Titled: FDA Approves Daxxify With Anticipated Product Label Differentiation; Raises Price Target From $25 To $35

By Benzinga Newsdesk

September 8, 11:19 AM

https://needham.bluematrix.com/sellside/EmailDocViewer?encrypt=b39360c5-a6d8-49eb-ab7d-06a90478a63f&mim

RVNC