Tag: New Product Approval

FDA approves Roche’s Inavolisib fo

USFDA has approved Inavolisib ((Itovebi) of Genentech in combination with palbociclib and fulvestrant, for the

FDA clears Bovaer – Elanco’s Met

Elanco Animal Health announced that the USFDA has completed its comprehensive, multi-year review of Bovaer

FDA approves Merck’s Winrevair (Sotate

FDA has approved Merck’s Biologic drug Winrevair (Sotatercept-CSRK) for Pulmonary Arterial Hypertension (PAH). The product

FDA approves Resmetirom for fatty liver

FDA has approved Madrigal Pharmaceuticals’ Rezdiffra (Resmetirom) for treatment of fatty liver disease (Noncirrhotic Nonalcoholic

USFDA approves Orchids innovation drug E

Indian Pharma company Orchid Pharma’s New Molecular Entity (NME) Enmetazobactam gets USFDA approval for treatment

FDA Approves Novartis Iptacopan for rare

FDA has approved Novartis’ Iptacopan (Fabhalta) for treatment of rare blood disease, Paroxysmal Nocturnal Hemoglobinuria

FDA approves SpringWorks’ Ogsiveo (Nir

Desmoid tumors are non-cancerous, but locally aggressive and invasive soft-tissue tumors that can lead to

FDA approves Astra Zeneca’s TRUQAP (ca

AstraZeneca’s TRUQAP (New Molecule Capivasertib) in combination with Faslodex (Fulvestrant) has been approved in the

Ascendis Pharma announces European appro

Danish Pharma firm Ascendis Pharma announced the European Commission approval for palopegteriparatide (Yorvipath), for treatment

FDA approves BMS’ Repotrectinib (Augty

Bristol Myers Squibb Augtyro™ (repotrectinib) is approved for treatment of adult patients with ROS1-positive non-small