FDA Archives - Page 8 of 220

2 minute read

Penny Stock PaxMedica’s African Sleeping Sickness Candidate Moves Closer To FDA Marketing Application Submission, Stock Rallies

April 12, 12:02 PM

PaxMedica achieves pivotal milestone with completion of three registration/validation batches for PAX-101, an IV suramin formulation, advancing towards FDA submission in Q4 2024. Potential breakthrough treatment for Stage 1 HAT, a fatal tropical disease.

PXMD

4 minute read

Candel Therapeutics Receives FDA Orphan Drug Designation For CAN-2409 For The Treatment Of Pancreatic Cancer

By Benzinga Newsdesk

April 11, 9:05 AM

Candel Therapeutics, Inc. (Candel or the Company) (NASDAQ:CADL), a clinical stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that

CADL

2 minute read

Why Is European Healthcare Tech Giant Philips Stock Trading Higher On Wednesday?

By Vandana Singh

April 10, 9:47 AM

Philips has finalized an agreement with US authorities and the FDA regarding the recall of Respironics ventilators. Consent decree mandates remediation prioritization and operational focus in the US. Business outlook and financial guidance remain stable.

PHG

1 minute read

FDA
News

BriaCell Highlights Data For Antibody-Drug Conjugate Resistant And Central Nervous System Metastatic Breast Cancer At AACR 2024

By Benzinga Newsdesk

April 9, 8:49 AM

PFS of 4.2 months in Phase 2 ADC resistant patients receiving Bria-IMT™ pivotal Phase 3 formulation is twice that of controls in similar studiesPFS results reinforced by larger number of prior treatments in

BCTX

2 minute read

Johnson & Johnson’s Carvykti Stands Ahead Of Bristol Myers’ Rival Blood Cancer Therapy With FDA Approval For Wider Population

By Vandana Singh

April 8, 2:19 PM

FDA approves Johnson & Johnson's Carvykti, a BCMA-targeted therapy for relapsed or refractory multiple myeloma patients, offering hope with increased manufacturing capacity and extended collaboration efforts.

JNJ

2 minute read

AstraZeneca/Daiichi’s Flagship Drug Enhertu Secures Accelerated FDA Approval For Pretreated Cancer Patients With Solid Tumor

By Vandana Singh

April 8, 10:34 AM

FDA approves Daiichi Sankyo's and AstraZeneca's Enhertu for unresectable or metastatic HER2+ solid tumors. Accelerated approval based on ORR and DOR. Boxed warnings for ILD/pneumonitis and embryo-fetal toxicity. ENHERTU's efficacy demonstrated in DESTINY trials.

AZN

2 minute read

Supernus Pharmaceuticals Faces Second FDA Rejection For Investigational Device For Parkinson’s Disease

By Vandana Singh

April 8, 10:11 AM

Supernus Pharmaceuticals receives FDA Complete Response Letter for SPN-830, an investigational apomorphine infusion device for Parkinson's disease. CRL indicates additional review needed for product quality and infusion device master file. No clinical safety or efficacy issues identified.

SUPN

3 minute read

On Friday April 5, 2024, Legend Biotech Reported CARVYKTI Becomes The First And Only BCMA-Targeted CAR-T Cell Therapy Approved By The FDA For Second-Line Treatment Of Multiple Myeloma

By Benzinga Newsdesk

April 8, 3:42 AM

New indication for this one-time infusion may provide patients with a treatment-free respite as early as first relapseLegend Biotech Corporation (NASDAQ:LEGN) (Legend Biotech), a global leader in cell therapy, announced

LEGN

2 minute read

FDA Approves Bristol-Myers/2seventy Bio’s Abecma For Earlier Use In Pretreated Blood Cancer Patients With Updated Boxed Warning On Secondary Cancer

By Vandana Singh

April 5, 1:37 PM

FDA approves Bristol-Myers Squibb and 2seventy Bio Abecma (ide-cel) for relapsed or refractory multiple myeloma after ≥2 prior therapies. Extends progression-free survival by 13.3 months vs. standard care.

BMY

2 minute read

Protara Therapeutics Shares Interim Data From Bladder Cancer Study, Raises $45M Via Equity

By Vandana Singh

April 5, 12:57 PM

Explore TARA-002's data in NMIBC treatment. Discover findings from three trials, including response rates, adverse events, and future plans. Stay updated on Protara Therapeutics' advancements in cancer therapy and FDA alignment for Choline Chloride.

TARA