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FDA Issues Draft Guidance Aimed at Improving Oncology Clinical Trials for Accelerated Approval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
US FDA accepts supplemental New Drug Application for Jardiance® for adults with chronic kidney disease

The U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Jardiance® (empagliflozin) tablets, which ...

January 24, 2023 | Tuesday | News
Acer Therapeutics and Relief Therapeutics Announce U.S. FDA Approval of OLPRUVA for Patients with Urea Cycle Disorders

“The FDA’s approval of OLPRUVA™, an innovative formulation of sodium phenylbutyrate packaged for the first time in single-dose envelopes,...

January 03, 2023 | Tuesday | News

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