Biotech Archives - Page 730 of 795

1 minute read

Back-To-Back Three Japanese Approvals For AstraZeneca’s Rare Disease Treatments

August 25, 8:50 AM

The Japan regulatory authority has approved AstraZeneca Plc (NASDAQ:AZN) and Merck Co Inc’s (NYSE:MRK) Lynparza (olaparib) for the adjuvant treatment of patients with…

AZN

3 minute read

FDA
News

Bidi Vapor Wins Merits Case Against FDA; Anticipates Revenue Growth

By Benzinga Newsdesk

August 25, 8:43 AM

GRANT, Fla., Aug. 25, 2022 (GLOBE NEWSWIRE) -- Kaival Brands Innovations Group, Inc. (NASDAQ:KAVL) ("Kaival Brands," the "Company," or "we"), the exclusive U.S. distributor of

KAVL

2 minute read

MindMed Announces First Patient Dosed In Phase 2b Trial Of MM-120 In Generalized Anxiety Disorder

By Benzinga Newsdesk

August 25, 7:39 AM

Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (NEO: MMED) (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today

MNMD

2 minute read

Iovance Biotherapeutics Initiates Biologics License Application Submission For Lifileucel In Advanced Melanoma

By Benzinga Newsdesk

August 25, 7:38 AM

Iovance Biotherapeutics, Inc. (NASDAQ:IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced that it has initiated a rolling Biologics License Application (BLA)

IOVA

1 minute read

Century Therapeutics Receives Study May Proceed Notification From FDA For CNTY-101

By Benzinga Newsdesk

August 25, 7:36 AM

– Investigational New Drug Application for CNTY-101, a CAR-iNK product candidate targeting CD19 for B-cell malignancies, cleared by FDA – – First cell product candidate engineered with six

IPSC

1 minute read

EXCLUSIVE: Longeveron’s Heart Disease Cell Therapy Poised To Secure European Patent

By Vandana Singh

August 25, 7:30 AM

The European Patent Office has issued a notice of its intent to grant Longeveron Inc (NASDAQ: LGVN) a patent related to methods to treat endothelial dysfunction and monitor the efficacy of allogeneic mesenchymal cell therapies, also known as medicinal signaling cells (MSCs).

LGVN

2 minute read

FDA
News

AstraZeneca Announced Ultomiris Approved in Japan for gMG

By Charles Gross

August 25, 5:07 AM

Ultomiris (ravulizumab) has been approved in Japan for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmaphaeresis.

AZN

3 minute read

FDA
News

AbbVie Announced FDA Approved the Use of Imbruvica for the Treatment of Pediatric Patients One Year and Older With cGVHD After Failure of One or More Lines of Systemic Therapy

By Charles Gross

August 24, 7:26 PM

AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved the use of IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.

ABBV

2 minute read

Recap Of Wednesday’s Biotech Catalysts – End Of the Day Summary

By Ragothaman Srinivasan

August 24, 6:53 PM

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ:BMRN) lead asset ROCTAVIAN (valoctocogene…

AIMD

2 minute read

BioMarin Receives European Commission’s Conditional Marketing Authorization For Gene Therapy Candidate

By Ragothaman Srinivasan

August 24, 5:49 PM

The European Commission (EC) has granted conditional marketing authorization (CMA) to BioMarin Pharmaceutical’s (NASDAQ: BMRN) lead asset ROCTAVIAN (valoctocogene roxaparvovec) gene therapy for the treatment of severe hemophilia A in adult patients.

BMRN