Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT®

The FDA clearance opens the door to the world's largest medical device market. With the cost effectiveness and demonstrated ability of our cardiac monitori...

April 07, 2023 | Friday | News
Accord BioPharma's Biosimilar Trastuzumab HLX02 BLA Accepted by US FDA

Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on development of oncology, immunology, and critical care therapies, ...

April 06, 2023 | Thursday | News
Perfuse Therapeutics' PER-001 Intravitreal Implant clears FDA IND application for Glaucoma trial

Perfuse Therapeutics, a biopharmaceutical company pioneering transformational therapies to treat ischemia-induced ocular diseases announced today that the ...

April 05, 2023 | Wednesday | News
InflaRx's Gohibic (vilobelimab) receives FDA Emergency Use Authorization for critically ill COVID-19 patients

Vilobelimab is the first authorized drug to control complement factor C5a, a protein that plays an important and often harmful role in the body's immune ...

April 05, 2023 | Wednesday | News
Vertex, CRISPR submit BLAs to FDA for exa-cel in sickle cell and beta thalassemia

-EU and UK filings completed in 2022; submissions validated by EMA and MHRA and the review procedure has begun as of January 2023-   -Vertex Pharmac...

April 04, 2023 | Tuesday | News
FDA Grants Accelerated Approval for PADCEV® with KEYTRUDA® for Urothelial Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Seagen Inc. (Nasdaq: SGEN) announced the U.S. Food and Drug Administrati...

April 04, 2023 | Tuesday | News
FDA Roundup: March 31, 2023

This week, the FDA approved three first-time generic animal drugs, bringing additional options to the table for veterinarians, pet owners and animal prod...

April 01, 2023 | Saturday | News
FDA approves RGVax's (HPV16 RG1-VLP) IND for Phase 1 clinical trials.

PathoVax LLC ("PathoVax"), a biotech company focused on developing a universally preventative Human Papillomavirus (HPV) vaccine - "RGVax", today announced...

March 31, 2023 | Friday | News
American Regent introduces FDA-approved Epinephrine Injection, USP

Epinephrine Injection, USP, is indicated for emergency treatment of allergic reactions (Type I), including anaphylaxis, which may result from insect stings...

March 31, 2023 | Friday | News
Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201 for Treatment of Systemic Lupus Erythematosus

CABA-201 data package and experience from prior autoimmune cell therapy INDs informed Phase 1/2 clinical trial design, including the initial dose to be eva...

March 31, 2023 | Friday | News
Tiziana Life Sciences Announces Anti-CD3 mAb Research for the Treatment of Alzheimer’s Disease

Data shows reduction of microglia activation and improvement in behavior in rodent model of Alzheimer’s disease (AD) Modulation of neuroinflammati...

March 31, 2023 | Friday | News
Piramal Pharma collaborates with Theracosbio for Bexagliflozin program.

TheracosBio recently received FDA approval for Brenzavvy™ (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor Piramal suppor...

March 30, 2023 | Thursday | News
Iovance Biotherapeutics Submits BLA for Lifileucel in Advanced Melanoma

Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel T cell-based cancer immunotherapies, today announced it h...

March 26, 2023 | Sunday | News
Commercial Supply Agreement Signed for Naloxone Nasal Spray to Reverse Opioid Overdoses

Harm Reduction Therapeutics, a 501(c)(3) non-profit pharmaceutical company whose mission is to prevent opioid overdose deaths by making low-cost naloxone a...

March 26, 2023 | Sunday | News

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