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BioPharma Drug Approval

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

J&J’s single-dose COVID-19 vaccine approved for emergency use in India

In a tweet, Health Minister Mansukh Mandaviya said, now India has five Emergency Use Authorization vaccines. He added that this will further boost the coun...

August 09, 2021 | News

KYOWA Partners with Bora to Manufacture Generic Product for Filing in Japan

This project will coordinate the manufacturing strengths in Taiwan and increase the visibility of Taiwan's pharmaceutical capabilities....

August 06, 2021 | News

Novavax and SII Announce Submission to Regulatory Agencies in India, Indonesia, Philippines

Novavax and Serum Institute of India file regulatory submissions to the Drugs Controller General of India and to regulatory agencies in...

August 06, 2021 | News

Yuyu Pharma Signs Exclusive Distribution Agreement with Novartis Korea

Yuyu Pharma, a pharmaceutical company based in Korea, and Novartis Korea announced today that the companies have entered into an agreement in which Yuyu wi...

August 04, 2021 | News

Vietnam to establish a manufacturing facility for Arcturus’ mRNA Covid-19 vaccine

Arcturus Therapeutics is a leading clinical stage company focused on messenger RNA (mRNA) medicines - one of the most advanced medicinal technologies in th...

August 03, 2021 | News

FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults...

July 29, 2021 | News

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