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BioPharma Drug Approval

Acepodia Gains FDA Clearance for ACE2016, Initiates Phase 1 Study on Solid Tumor Treatment

This clearance marks a significant milestone for Acepodia, allowing the initiation of a Phase 1, first-in-human clinical trial to assess th...

February 05, 2024 | News

Biosyngen's BST02 Granted FDA Fast Track for Liver Cancer Treatment

Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an ...

February 02, 2024 | News

Vertex's Breakthrough VX-548: Transforming Pain Management with Rapid Relief and Safety, A New Era in Acute Pain Solutions

Treatment with VX-548 led to statistically significant improvement in pain compared to placebo as well as a clinically meaningful reduction in pain from ...

January 31, 2024 | News

CellVax Therapeutics Receives FDA Clearance for FK-PC101 Cancer Immunotherapy IND

FK-PC101 is CellVax's novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatec...

January 30, 2024 | News

Oricell's OriCAR-017 CAR-T Therapy IND Cleared by FDA for Relapsed/Refractory Multiple Myeloma

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D. The therapy leverages Oricell's proprietary platforms including Ori®Ab...

January 30, 2024 | News

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

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