BioPharma APAC - Leading Source of Biopharmaceutical Intelligence in Asia Pacific

BioPharma Drug Approval

X-Therma Announces XT-Thrive® Drug Master File (DMF) Accepted by U.S. Food and Drug Administration (FDA)

"This submission was the culmination of several years of development activities and the establishment of a Good Manufacturing Practices (GMP) manufacturing...

April 19, 2024 | News

BioCity Biopharma's Cancer Therapy BC2027 Gets FDA Nod for Phase 1 Trials

BioCity Biopharma announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for a Pha...

April 10, 2024 | News

Dizal's Sunvozertinib Secures FDA Breakthrough Therapy Designation for First-Line EGFR Mutated NSCLC Treatment

Dizal announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the firs...

April 08, 2024 | News

RemeGen's Telitacicept Secures FDA Fast Track Status for Primary Sjögren's Syndrome Treatment

RemeGen , a commercial-stage biotechnology company, obtained Fast Track Designation (FTD) by the United States Food and Drug Administration (FDA) rec...

April 03, 2024 | News

Innovent and HUTCHMED's Endometrial Cancer Therapy Receives Priority Review by China's NMPA

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality me...

April 03, 2024 | News

Eisai and Biogen Seek FDA Approval for Monthly Alzheimer's Treatment Dosing

Eisai Co., Ltd. and Biogen Inc. have taken a significant step forward in the fight against Alzheimer’s disease by submitting a Supplemental Biologics...

April 01, 2024 | News

Alebund Pharmaceuticals Receives FDA Orphan Drug Designation for AP303 in ADPKD Treatment

Alebund Pharmaceuticals ("Alebund" or the "Company"), an integrated biopharmaceutical company focusing on developing innovative therapies for th...

April 01, 2024 | News

FDA Approves Vafseo for Anemia in Dialysis Patients

SL Vifor is pleased that its partner Akebia Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo (vadadustat) ...

March 29, 2024 | News

MSD announces FDA approval of WINREVAIR™ for pulmonary arterial hypertension, introducing a novel class of therapy.

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

March 27, 2024 | News

DigmBio's Breakthrough Cancer Drug Clears Korean Regulatory Hurdle

BioDuro-Sundia's partner, DigmBio, a South Korean biotechnology company, announced its selective PARP1 inhibitor for the treatment of triple-negative breas...

March 26, 2024 | News

Takeda Receives FDA Approval for ICLUSIG as a First-Line Treatment in Ph+ ALL

Takeda Receives FDA Approval for ICLUSIG as a First-Line Treatment in Ph+ ALL Takeda Pharmaceutical Company Limited (TSE: 4502; NYSE: TAK) is plea...

March 25, 2024 | News

Vertex Pharmaceuticals Receives FDA Clearance for Innovative ADPKD Drug Trial

Vertex Pharmaceuticals Incorporated announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug Application (IND) f...

March 22, 2024 | News

Oscotec Inc. Gains FDA Orphan Drug Designation for Promising ITP Treatment Cevidoplenib

Oscotec Inc. has secured orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for its SYK inhibitor, Cevidoplenib, to treat immun...

March 22, 2024 | News

Singapore Approves Everest Medicines' NEFEGAN® for Adult Primary IgA Nephropathy

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, development, manufacturing and commerc...

March 20, 2024 | News

Stay Connected