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BioPharma Drug Approval

FDA Approves First Respiratory Syncytial Virus (RSV) Vaccine

U.S. Food and Drug Administration approved Arexvy, the first respiratory syncytial virus (RSV) vaccine approved for use in the United States. Arexvy i...

May 04, 2023 | News

FDA Approves Teva and MedinCell's UZEDY™ for Adult Schizophrenia Treatment

This new treatment provides adults living with schizophrenia a long-acting formulation that offers flexible 1- and 2-month dosing intervals1 In a ...

May 01, 2023 | Regulatory

RNAimmune's RV-1730 COVID-19 booster vaccine receives FDA clearance for Phase 1 trial.

The proposed clinical study will involve in an evaluation of RV-1730 for its safety and prophylaxis efficacy against SARS-CoV-2 infection with people...

April 28, 2023 | News

Bridge Biotherapeutics Receives FDA Approval for First-in-Human Study of BBT-207, a 4th Gen EGFR TKI.

The company has been notified by the FDA that the Phase 1/2 clinical trial may proceed The latest preclinical data explored the antitumor effica...

April 24, 2023 | News

Quizartinib NDA Review for Patients with Newly Diagnosed FLT3-ITD Positive AML Extended by FDA

The FDA has extended the Prescription Drug User Fee Act (PDUFA) action date by three months to July 24, 2023 to allow additional time to review requested u...

April 21, 2023 | News

CARsgen's CT041 receives IND clearance from NMPA for pancreatic cancer therapy.

Dr Raffaele Baffa, Chief Medical Officer of CARsgen, commented that "We are glad to receive the IND clearance from NMPA for the adjuvant treatment of ...

April 20, 2023 | News

Ajinomoto Bio-Pharma Services Receives FDA Approval for High Potency Fill Line

"Receiving FDA approval on our HPAPI fill line is an exciting milestone for our company, and couldn't have happened without the hard work, hours of prepara...

April 20, 2023 | News

Crystal Formulation Services Receives China Drug Manufacturing License for Milestone Formulation Capability

Crystal Formulation Services, a subsidiary of Crystal Pharmatech, has achieved an exciting new milestone in its formulation capabilities. The company was r...

April 20, 2023 | News

Biosyngen announces FDA IND approval of its second product for EBV-positive lymphoma

A few months earlier, the Company's first product (BRG01) targeting relapsed/metastatic nasopharyngeal cancer has been granted IND approval by both the US ...

April 19, 2023 | News

FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA® (pembrolizumab)

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has accepted for...

April 17, 2023 | News

Minghui Pharma's MH004 Cream Succeeds in Phase 2 Trial for Atopic Dermatitis, Global Phase 3 MRCT Cleared by FDA

Study met both primary and all key secondary endpoints Mean percentage change from baseline in Eczema Area and Severity Index (EASI) score was -78.7% in...

April 14, 2023 | News

Biosyngen received China NMPA IND approval for its T-cell redirection therapy targeting EBV-positive Lymphoma

Currently, commercially available cell therapies, such as CD19 CAR-T, are designed for the treatment of B cell lymphoma or acute lymphoblastic leukemia. Tr...

April 12, 2023 | News

Boan Biotech's Biologics License Application for Boyounuo® (Bevacizumab Injection) Accepted in Brazil

Envisioned to be "a leading global biopharmaceutical company", Boan Biotech develops biologics for both Chinese and international markets, including E...

April 12, 2023 | News

JW Therapeutics' Relma-cel approved for systemic lupus erythematosus trial.

SLE is a complex autoimmune disease with diverse clinical manifestations involving many organs and systems. It is estimated that China has 1 mill...

April 11, 2023 | News

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