European Pharmaceutical Review

AUGUST 31, 2023

In addition, radionuclide therapy has the potential to achieve high efficacy rates since the administered drugs spare surrounding healthy tissue, thus, reducing the burden on the patient. 1-4 Besides these drug products, several companies worldwide are developing radiotheranostics in clinical trials built on various radionuclides.

Food and Drug Administration 87

Food and Drug Administration Manufacturing Safety Transportation 87

Pharmaceutical Technology

FEBRUARY 16, 2023

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) for Shanghai Henlius Biotech ’s proposed biosimilar HLX02 (trastuzumab for injection). Accord BioPharma (Accord US), the business partner of Shanghai Henlius Biotech, has submitted the BLA.

Food and Drug Administration 52

Food and Drug Administration FDA Safety Biopharma 52

European Pharmaceutical Review

DECEMBER 14, 2023

This opinion was based on the results from the BRIGHT SKY programme, which included three Phase III clinical trials to monitor efficacy and safety in women with moderate to severe VMS. Fezolinetant, marketed as Veozah, received US Food and Drug Administration approval in May 2023. “We

Food and Drug Administration 82

Food and Drug Administration Biopharma Medicine Food 82

European Pharmaceutical Review

DECEMBER 21, 2022

Most psychedelic drugs are Schedule I controlled substances, which means that very strict legal and regulatory controls accompany their use” Some psychedelics originate in nature and have been used by Indigenous cultures for thousands of years; others are manipulated or manufactured. 1 Such restraints have stood solid for decades.

Food and Drug Administration 115

Food and Drug Administration Medicine Food Government 115

Pharmaceutical Technology

FEBRUARY 15, 2023

Kinnate Biopharma has received Fast Track designation from the US Food and Drug Administration (FDA) for its pan-FGFR inhibitor, KIN-3248, to treat unresectable, locally advanced or metastatic cholangiocarcinoma (CCA). Kinnate Biopharma expects to receive initial dose escalation data in the second half of this year.

Food and Drug Administration 52

Food and Drug Administration FDA Biopharma Safety 52

European Pharmaceutical Review

NOVEMBER 23, 2022

The US Food and Drug Administration (FDA) has approved Hemgenix (etranacogene dezaparvovec), the first gene therapy for adults with Haemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening haemorrhage, or have repeated, serious spontaneous bleeding episodes.

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FDA Food and Drug Administration Biopharma Food 128

pharmaphorum

DECEMBER 9, 2022

Nasdaq: AUTL), a clinical-stage biopharma and a portfolio company of Syncona Ltd., This means that enrolment is now completed for the initial target or morphological cohort to form the basis of a Biological License Application (BLA) submission by the end of CY2023 to the US Food and Drug Administration (FDA).

Food and Drug Administration 79

Food and Drug Administration Safety Biopharma Patients 79