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BioPharma Drug Approval

Eisai Seeks Approval in Japan for Ultrahigh-Dose Mecobalamin in ALS

This application is based on the results of JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), a Phase III trial to evaluate e...

January 29, 2024 | News

Nanoform Achieves Key Milestone in Clinical Trials for Enhanced Enzalutamide

These were from a relative bioavailability study of nanocrystalline-enabled enzalutamide (nanoenzalutamide) tablet formulation, an alternative to the amorp...

January 29, 2024 | News

Bristol Myers Squibb's Abecma CAR T Therapy Earns Favorable CHMP Opinion for Earlier Lines in Multiple Myeloma

Recommendation for approval based on Phase 3 KarMMa-3 study in which Abecma demonstrated superiority over standard regimens, significantly improv...

January 26, 2024 | News

EMA grants Orphan Drug Designation to GC Biopharma's Sanfilippo Syndrome (Type A) Treatment

GC1130A has previously achieved notable milestones by securing both Rare Pediatric Disease designation (RPDD) and Orphan Drug Designation (ODD) from the U....

January 24, 2024 | News

Australia's Island Pharma Advances ISLA-101 Study: Third Cohort Successfully Dosed

This achievement follows the recent confirmation from the Data Safety Review Committee that ISLA-101 has been deemed safe and well-tolerated in the 16 subj...

January 23, 2024 | News

TGA Grants Approval to Australia's Pioneering RSV Vaccine, AREXVY

AREXVY has been approved by the Therapeutic Goods Administration (TGA) for Australians 60 and over to protect against lower airway infection caused by re...

January 19, 2024 | Regulatory

CARsgen's CT011 Granted NMPA IND Clearance for GPC3-Positive Stage Ⅲa Liver Cancer

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignan...

January 16, 2024 | News

Japan Approves Neurolief's Relivion®, Paving the Way for At-Home Migraine Treatment.

Relivion® is a novel, non-invasive multi-channel brain neuromodulation technology. It stands out by concurrently stimulating the occipital and tri...

January 12, 2024 | News

OBI Pharma's partner Biosion announces FDA clearance for the Phase 1/2 study of OBI-992 (TROP2 ADC)

First clinical trial to evaluate the safety and efficacy of OBI-992 (a.k.a BSI-992), a novel antibody drug conjugate (ADC) targeting TROP2 - Dosing of f...

January 09, 2024 | News

Caliway's CBL-514 IND for Dercum's Disease Phase 2 Study Accepted by FDA

Dercum's disease is a rare disease characterized by the growth of painful lipomas. The pain can be severe, chronic (> 3 months) and often disabling. So ...

January 09, 2024 | News

Akeso's Cadonilimab Granted NMPA Acceptance for First-Line Gastric Cancer Treatment.

This will be the second indication for which cadonilimab has received approval in China, following its use as a monotherapy treatment for recurrent or...

January 08, 2024 | News

EMA Validates Bristol Myers Squibb’s Repotrectinib Application for ROS1-Positive Lung Cancer

-Bristol Myers Squibb (NYSE: BMY) announced that the European Medicines Agency (EMA) has validated its marketing authorization application for t...

January 03, 2024 | News

Mundipharma Greenlights European Approval for REZZAYO® in Treating Adult Invasive Candidiasis

The approval is based on the positive results of the pivotal Phase III ReSTORE clinical trial and is supported by STRIVE's Phase II clinical trials and a...

January 01, 2024 | News

Breakthroughs Unveiled: A Year of Groundbreaking Novel Drug Approvals in 2023

Innovative drugs often mean new treatment options for patients and advances in health care for the American public. When it comes the development of new dr...

December 29, 2023 | News

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