You are here: Industry Insights > FDA

News List

FDA Approves Avapritinib for Advanced Systemic Mastocytosis americanpharmaceuticalreview
June 18, 2021
The U.S. FDA approved avapritinib (Ayvakit™, Blueprint Medicines Corp.) for adult patients with advanced systemic mastocytosis (AdvSM), including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated ...
MannKind and United Therapeutics NDA for Tyvaso DPI™ Accepted by U.S. FDA americanpharmaceuticalreview
June 18, 2021
MannKind Corporation and United Therapeutics Corporation announced that the U.S. FDA accepted for priority review the New Drug Application (NDA) for Tyvaso DPI™ (inhaled treprostinil) for the treatment of pulmonary arterial hypertension (PAH) and ...
Agenus BLA for Balstilimab as Treatment for Cervical Cancer Granted Priority Review by U.S. FDA americanpharmaceuticalreview
June 18, 2021
Agenus Inc., an immuno-oncology company with an extensive pipeline of agents including checkpoint antibodies, cell therapies, adjuvants, and vaccines that activate immune response to cancers and infections announced that the U.S. FDA accepted Agenus’ ...
Novartis prostate cancer drug gets FDA breakthrough designation pharmaceutical-technology
June 18, 2021
The FDA breakthrough designation is based on positive results from the Phase III VISION study of ¹⁷⁷Lu-PSMA-617.
Aleor Dermaceuticals gets USFDA nod for Testosterone Topical Solution expresspharma
June 18, 2021
It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism and Hypogonadotropic hypoqonadisrn.
Lupin gets US FDA approval for Sevelamer Hydrochloride Tablets expresspharma
June 18, 2021
They are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis.
US FDA accepts Amneal’s Biologics License Application for Bevacizumab expresspharma
June 18, 2021
Bevacizumab represents the third biosimilar BLA currently filed by Amneal with the FDA.
Spark™ Aligners Receive FDA Clearance For Orthodontic Treatment Of Kids, Giving Parents A New Option With Significant Treatment Advantages Over The Leading Competitor prnasia
June 17, 2021
Ormco Corporation, a global leader of orthodontic solutions, announced it has received U.S. Food and Drug Administration (FDA) clearance for the use of its Spark™ Clear Aligner System for orthodontic treatment in patients with both primary and ...
InnoCare Announces Orphan Drug Designation of Gunagrabtinib by US FDA for Treatment of Cholangiocarcinoma prnasia
June 17, 2021
InnoCare, a leading biopharmaceutical company focusing on cancer and autoimmune diseases, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its pan-FGFR inhibitor gunagratinib (ICP-192) for the ...
Jounce Therapeutics Receives FDA Clearance of Investigational NDA for Anti-CCR8 Antibody americanpharmaceuticalreview
June 17, 2021
Jounce Therapeutics Inc., a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, announced the U.S. FDA's clearance of its Investigational New Drug (IND) application for JTX-1811 ...

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page