FDA Archives - Page 142 of 220

1 minute read

November 21, 5:19 PM

Treace Medical Concepts, Inc. ("Treace") (NASDAQ:TMCI), a medical technology company driving a fundamental shift in the surgical treatment of hallux valgus (commonly known as bunions) through its

TMCI

2 minute read

Zymeworks Announces Abstract For Zanidatamab In Late-Line HER2-Positive Hormone-Receptor Positive Metastatic Breast Cancer At The San Antonio Breast Cancer Symposium

By Benzinga Newsdesk

November 21, 10:07 AM

Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the publication of an abstract highlighting new clinical data for zanidatamab, a

ZYME

2 minute read

Biofrontera To Launch Phase 3 Clinical Study Evaluating Ameluz-PDT For The Treatment Of Actinic Keratosis On The Extremities, Neck and Trunk

By Benzinga Newsdesk

November 21, 9:49 AM

Biofrontera Inc. (NASDAQ:BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of a randomized, double-blind, vehicle-controlled,

BFRI

2 minute read

Cellectar Biosciences Announces Presentation Of Data On CLR 12120 Series Of Targeted Alpha-Emitting Therapies At The 13th Annual World ADC Conference

By Benzinga Newsdesk

November 21, 9:43 AM

Cellectar Biosciences, Inc. (NASDAQ:CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of drugs for the treatment of cancer, today announced the

CLRB

3 minute read

Genmab Announces FDA Acceptance For Priority Review Biologics License Application For Epcoritamab For The Treatment Of Relapsed/Refractory Large B-Cell Lymphoma

By Benzinga Newsdesk

November 21, 9:02 AM

Epcoritamab BLA accepted for FDA Priority review; FDA action date is May 21, 2023 Epcoritamab could become the first subcutaneous bispecific antibody approved for the treatment of LBCL BLA submission supported by Epcoritamab BLA accepted for FDA Priority review; FDA action date is May 21, 2023

ABBV

2 minute read

Avadel Pharmaceuticals PR Confirms Favorable Ruling On Motion To Delist REMS Patent From FDA’s Orange Book

By Benzinga Newsdesk

November 18, 3:46 PM

Avadel Pharmaceuticals plc (NASDAQ:AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, announced today that the United States District Court for the District of Delaware (the

AVDL

1 minute read

Apellis Pharma Shares Jump As FDA Accepts Its Lead Product Application For Eye Disease

By Vandana Singh

November 18, 1:12 PM

The FDA has accepted for review Apellis Pharmaceuticals Inc’s (NASDAQ:APLS) unsolicited major amendment to the New Drug Application (NDA) for intravitreal…

APLS

1 minute read

Iovance Biotherapeutics Pushes FDA Rolling Submission Deadline Into Next Year For Its Lead Skin Cancer Candidate

By Vandana Singh

November 18, 1:09 PM

Iovance Biotherapeutics Inc (NASDAQ:IOVA) announced that its ongoing rolling Biologics License Application (BLA) submission to the FDA for lifileucel…

IOVA

5 minute read

Three Months Wait Time For Twitter Blue Mark Verification, Zuckerberg’s WhatsApp And Metaverse Plans, China’s COVID-19 Measures Hurt Alibaba’s Biggest Event: Top Stories Friday, Nov. 18

By Vandana Singh

November 18, 9:59 AM

Reuters

AAPL

1 minute read

IVERIC bio Secures Breakthrough Therapy Tag For Its Flagship Geographic Atrophy Candidate

By Vandana Singh

November 18, 7:58 AM

The FDA has granted Breakthrough Therapy designation to IVERIC bio Inc’s (NASDAQ:ISEE) avacincaptad pegol (ACP, also known as Zimura), a novel investigational…

ISEE