BioSpace News Archive

Ascentage Pharma (6855.HK), today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been granted a Fast Track Designation (FTD) by the US Food and Drug Administration (FDA) for the treatment of patients with unresectable or metastatic melanoma, relapsed/refractory to prior immuno-oncologic agent (IO) treatments.

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), today announced that the National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for Sintilimab in combination with chemotherapy (cisplatin plus paclitaxel or cisplatin plus 5-fluorouracil) for the first-line treatment of esophageal squamous cell carcinoma (ESCC).

Innovative California Biosciences International, Inc., (“ICBII”), has announced the approval of its 7th patent for Blood-Brain Barrier (BBB) Permeable Peptide Compositions.

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19.

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

Synlogic a clinical stage company bringing the transformative potential of synthetic biology to medicine, announced the pricing of its underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $3.00 per share.