BioPharma Drug Approval

Everest Medicines Announces Major Regulatory Updates in Taiwan and South Korea

-- Taiwan Food and Drug Administration grants Accelerated Approval Designation (AAD) to Nefecon -- -- Ministry of Food and Drug Safety in S...

 November 28, 2022 | News

Hugel's 'Letybo' First in Korea to Obtain Marketing Approval from Australia

Obtained marketing approval on the 23rd (local time) from the Therapeutic Goods Administration (TGA) of Australia for the indication of gl...

 November 25, 2022 | News

First Patient Dosed in Phase II 'IPAX-Linz' Study of TLX101 for Glioblastoma Therapy

TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of Telix's lead therapeutic clinical programs and has been granted orphan drug designation ...

 November 22, 2022 | News

Nuance Pharma Announces Clearance of IND Application for Respiratory Syncytial Virus (RSV) Vaccine in China

MVA-BN RSV, is being developed for the prevention of respiratory syncytial virus (RSV) in older adults. The vaccine incorporates five distinct RSV antigens...

 November 15, 2022 | News

U.S. FDA Grants EUA for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases,...

 October 24, 2022 | News

Chinese NMPA Approves Pivotal Phase III Study of TLX591-CDx for Prostate Cancer Imaging

The IND application was submitted in partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix's partner in the Greater China reg...

 October 17, 2022 | News

Kira Pharmaceuticals Announces IND Approval from Chinese NMPA

Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, announced today th...

 October 17, 2022 | News

FDA Accepts BioMarin's Biologics License Application

If Approved, Would Be 1st Gene Therapy in U.S. for Treatment of Severe Hemophilia A PDUFA Target Action Date is March 31, 2023 BioMarin Pharmaceutic...

 October 13, 2022 | News

Lilly receives U.S. FDA Fast Track designation for tirzepatide

Eli Lilly and Company (NYSE: LLY) announced  that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investig...

 October 11, 2022 | News

China NMPA Approves Selpercatinib for the Treatment of Patients with RET-driven Lung and Thyroid Cancers

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

 October 10, 2022 | News

FDA Clears World's First Single-use 5mm Laparoscope with Auto-Focus

"The addition of the auto-focus capability will truly enhance the likelihood of swift adoption in the surgical marketplace. This would especially be true i...

 October 06, 2022 | News

Transcenta Received IND Clearance from FDA

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, resear...

 October 05, 2022 | News

Chinese NMPA Approves Study of Telix Kidney Cancer Imaging Candidate

The investigational new drug (IND) application was submitted by Telix's partner in the Greater China region, Grand Pharmaceutical Group Limited (...

 September 28, 2022 | News

Menarini and SciClone to Develop and Commercialize Vaborem® in China to Treat Antimicrobial Resistant Infections

Vaborem®, a patented combination of meropenem and vaborbactam, is expected to address the rising prevalence of carbapenem-resistant Klebsiella pneumo...

 September 21, 2022 | News


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