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BioPharma Drug Approval

Everest Medicines Gets NMPA Approval for Nefecon® in China for IgA Nephropathy

--Nefecon® is the first approved medicine with an IgAN indication in China-- --The approval marks a new era of IgAN treatment for Chinese patient...

November 27, 2023 | News

Ark Biopharmaceutical's AK0610 gets NMPA IND approval for RSV antibody

This antibody drug is bioengineered based on a neutralizing antibody originally isolated from a recovered child from respiratory syncytial virus (RSV) infe...

November 24, 2023 | News

Singapore's Ministry of Health (MOH) adds zanubrutinib to its cancer drug list for six indications

According to recent statistics, from 2017 to 2021, cancer claimed 29,500 lives in Singapore, with a total of 84,002 reported cancer cases[1]. BeiGene's Zan...

November 23, 2023 | News

BeiGene and Ensem Therapeutics Partner to Advance CDK2 Inhibitor

“We are committed to developing novel molecules with the potential to transform the therapeutic landscape for cancer patients, and this partnership f...

November 23, 2023 | News

Merz Therapeutics Receives TGA Approval for XEOMIN® in Australia

This marks a significant milestone as XEOMIN® is the first approved neurotoxin for the treatment of this condition in the Australian market. Addit...

November 23, 2023 | News

Innovent and AnHeart's Taletrectinib NDA Accepted by China's NMPA

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

November 23, 2023 | News

Ark Biopharma's AK0610 Receives NMPA IND Approval for RSV Neutralizing Antibody

It is anticipated to protect infants throughout an entire RSV season. ArkBio licensed the drug's intellectual properties from the Institute of Microb...

November 23, 2023 | News

Senhwa Biosciences Granted FDA IND for Phase II Study of Silmitasertib in Viral Community-Acquired Pneumonia (CAP)

The trial is a phase II multi-center, randomized-controlled interventional prospective study, and the purpose of this trial is to investigate whether ...

November 22, 2023 | News

IASO Bio Sets Up Global CAR-T Center in China for Global MM Patients

On June 30, 2023, the China National Medical Products Administration (NMPA) approved the marketing of Equecabtagene Autoleucel Injection (brand name: FUCAS...

November 22, 2023 | News

KN026 was Granted Breakthrough Therapy Designation by CDE

Gastric cancer is one of the most common gastrointestinal malignancies in the world, and the number of new cases and deaths of gastric cancer in China...

November 08, 2023 | News

Everest Medicines Receives Approval in Macau for Nefecon® in Primary IgA Nephropathy

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

October 30, 2023 | News

Life Molecular Imaging and Sinotau Gain Regulatory Approval for Neuraceq® in China

Life Molecular Imaging (LMI) and Sinotau Pharmaceutical Group are pleased to announce Neuraceq® (with Chinese trade name 欧韦宁®, florbetaben F-...

October 25, 2023 | News

Australia's Certa Therapeutics: FT011 Granted US FDA Orphan Drug Status for Systemic Sclerosis

Orphan Drug Designation is granted by the FDA to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 pe...

October 24, 2023 | News

FDA Approves PENBRAYA™: First Vaccine for 5 Common Meningococcal Serogroups in Teens

PENBRAYA™ provides the broadest serogroup coverage (meningococcal groups A, B, C, W and Y) of any meningococcal vaccine available in the U.S. ...

October 23, 2023 | News

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