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
FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval

"The FDA's accelerated approval program has provided patients with cancer earlier access to novel treatments that can be practice changing," said Richard P...

March 26, 2023 | Sunday | News
Pharming's Joenja® approved by US FDA for APDS treatment.

APDS (activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome) is a rare and progressive primary immunodeficiency Joenja® is a targeted treat...

March 26, 2023 | Sunday | News
Carina Biotech Receives FDA “Safe to Proceed” Letter

Receives greenlight from the FDA for Phase 1/2a clinical trial of CNA3103 On track to commence patient enrollment during the first half 2023 Carina B...

January 24, 2023 | Tuesday | News

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