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Drug Approval

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

DCGI has approved biotechnology Panacea Biotech to manufacture Sputnik V in India.

The license is a necessary condition for using Sputnik V produced by Panacea Biotec in India. The batches produced at Panacea Biotec’s faciliti...

July 05, 2021 | News

BioGX Receives FDA EUA Approvals

BioGX, a global provider of molecular diagnostic solutions, announced that the United States Food and Drug Administration has issued Emergency Use Authoriz...

July 05, 2021 | News

Lupin Announces FDA Approval for SOLOSEC® to Combat STD's

SOLOSEC® demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on a landmark Phase 3 clinical ...

July 04, 2021 | News

Innovent Biologics Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market

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

June 22, 2021 | News

Chinese Bioheng Biotech received ODD from the U.S. FDA

"CTD401 is the first innovative product based on our next-generation generic CAR-T technology platform. It has excellent efficacy and superior safety in ex...

June 21, 2021 | News

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