Pharmaceuticals, Biotechnology and Life Sciences
Announcing the approval of Teva’s Sabril generic tablets, FDA Commissioner, Scott Gottlieb said that prioritizing the approval of generic drugs to compete with medicines that face little or no competition is the Agency’s key part of efforts to support access and reduce drug costs to patients.
Novartis has secured its crizanlizumab (SEG101) Breakthrough Therapy designation US Food and Drug Administration (FDA), for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD).
MatriSys Bioscience is waiting to meet with the US FDA to complete preparations for its company-sponsored Phase 2 trial of its anti-atopic dermatitis topical drug candidate, MSB-01, it said Wednesday.
PledPharma has filed an application for an Orphan Drug Designation (ODD) to the US FDA for the its drug candidate which should reduce liver injury by paracetamol overdose, Aladote.
The US Food & Drug Administration (FDA) has granted Fast Track designation to Nordic Nanovector’s Betalutin (177Lu-lilotomab satetraxetan) for the treatment of…
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s partner’s Loxo Oncology’s New Drug Application (NDA), and granted Priority…
The U.S. Food and Drug Administration has approved AkaRx’s Doptelet (avatrombopag) tablets to treat low blood platelet count (thrombocytopenia) in adults with…
Eli Lilly said Tuesday that the U.S. Food and Drug Administration (FDA) has approved a label update for Taltz injection 80 mg/mL to…
The U.S. Food and Drug Administration has approved Ultragenyx Pharmaceutical’s Crysvita (burosumab), the first drug approved to treat adults and children ages…
Should I get breast implants? Are there alternatives? Will they need to be replaced? And if I decide to get…