NEW DRUG APPROVALS, ANTHONY CRASTO DRUG APPROVALS BY DR ANTHONY MELVIN CRASTO https://newdrugapprovals.org/ DR ANTHONY MELVIN CRASTO ALL ABOUT DRUGS, by Worlddrugtracker DR ANTHONY MELVIN CRASTO MY BLOGS ON MED CHEM, New Drug Approvals, ALL ABOUT DRUGS, WORLD DRUG TRACKER, MEDICINAL CHEMIS...
New Drug Approvals by FDA & EMA (Mid-2020 Recap) US secures world stock of key Covid-19 drug remdesivir Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma INTERCEPT RECEIVES COMPLETE ...
1.New Drug Approvals by FDA & EMA (Mid-2020 Recap) 2.US secures world stock of key Covid-19 drug remdesivir 3.Bristol Myers Squibb and bluebird bio Provide Regulatory Update on Idecabtagene Vicleucel (ide-cel, bb2121) for the Treatment of Patients with Multiple Myeloma 4.INTERCEPT RECEI...
2020 FDA/EMA approvals for new immunotherapy drug technologies and applications。
In 2023, the European Medicines Agency (EMA) granted approval to 77 new molecular entities (NMEs), consisting of 45 new chemical entities (NCEs) and 32 new biological entities (NBEs). These pharmacological agents encompass a broad spectrum of therapeutic domains, including oncology, cardiology, ...
Food & Drug AdministrationThe article reports on the recommendations for drug approval on 40 new drugs by the European Medicines Agency (EMA) to the U.S. Food and Drug Administration (FDA) for treating patient's with rare diseases.doi:10.1038/nrd4548Mullard A...
Drug development must comply with relevant regulatory requirements, guided by industry guidelines developed by regulatory agencies, with reference to relevant use cases. The approval of new drugs must be based on evidence generat...
These approvals bring the 2024 yearly total of positive opinions for new medicines to 79. There have been four negative opinions in 2024 so far, and 63 extensions of indications. In addition, EMA announced that Bruno Sepodes, a specialist in pharmacology, has been elected as the new chair ...
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, ...
由此可见,免疫疗法已经进入一个快速发展阶段,在2021年还将会有更多的药物被批准上市。不管是mAb、ADC还是CAR-T,都离不开细胞培养过程。因此相关药物的生产工艺也离不开细胞库的检定。 参考文献: 2020 FDA/EMA approvals for new immunotherapy drug technologies and applications 来源:搜狐...