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BioPharma Drug Approval

FDA Pre-Submission for Saliva-Based Glucose Test to Replace Invasive Finger-Prick

The purpose of this Pre-Submission is to confirm with the FDA the clinical trial design, including trial objectives. This interaction will allow the FDA to...

October 20, 2021 | News

MSN Labs Launches Empagliflozin tablets at an affordable price for Diabetes Management in India

‘EMPAONE’ is intended to provide diabetes patients in need across India with an affordable and accessible therapeutic option. India being the d...

October 19, 2021 | News

Dr. Reddy's Laboratories Announces the Launch of Carmustine for Injection

The BiCNU® brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 a...

October 18, 2021 | News

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

"Today's action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children," said Peter Marks, M.D., Ph.D.,...

October 11, 2021 | News

Japan Approves Pfizer’s CIBINQO® to treat Atopic Dermatitis

Pfizer Inc. (NYSE: PFE) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved CIBINQO® (abrocitinib), ...

October 04, 2021 | News

South Korea Advances Treatment of Polymyositis

Immunoforge (Co-CEOs Sung-min Ahn, Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that th...

September 28, 2021 | News

Mirum. Takeda to Develop and Commercialize Maralixibat for Rare Pediatric Liver Diseases in Japan

Partnership leverages Takeda’s leadership in rare disease, gastroenterology, and hepatology to advance maralixibat in a major market Mirum P...

September 23, 2021 | News

FDA granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test

FDA Approves Tissue-Based NGS Companion Diagnostic for Takeda's Targeted Therapy for NSCLC Patients with EGFR Exon20 Insertion Mutations The U.S. Food and...

September 16, 2021 | News

Yiling Pharmaceutical's Yishen Yangxin Anshen Tablets Granted Drug Certificate

With the functions of reinforcing kidney, nourishing heart, and tranquilizing mind, this drug offers a new treatment for insomnia with the symptoms of slee...

September 08, 2021 | News

Moderna Announces Submission of Data to European Medicines Agency for its COVID-19 Vaccine Booster

-Moderna, Inc. a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced it has submitted for a conditional ...

September 06, 2021 | News

Enzene Biosciences Ltd. obtains a Marketing Authorization for its Denosumab Biosimilar drug in India

Osteoporosis is a commonly occurring condition associated with advanced age, and is frequently caused by oestrogen decline in post-menopausal women. It can...

August 29, 2021 | News

Senhwa's Silmitasertib Receives US FDA Fast Track Designation

Senhwa Biosciences, Inc., a drug development company focused on first-in-class therapeutics for oncology, rare diseases, and novel coronaviruses, today ann...

August 19, 2021 | News

FDA Grants Emergency Use Authorization for Two Next-Generation COVID-19 Assays from Thermo Fisher Scientific

Both PCR-based kits leverage an updated design from the original TaqPath assays, targeting eight different genes across three regions of the virus that cau...

August 17, 2021 | News

InxMed's IN10018 Receives U.S. FDA Fast Track Designation

InxMed (Nanjing) Co., Ltd. ("InxMed" or "Company"), a clinical stage biotech company dedicated to developing innovative, individualized medicines with inte...

August 16, 2021 | News

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