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FDA Approves First Drug to Improve Growth in Children with Most Common Form of Dwarfism FDA
November 22, 2021
Today, the U.S. Food and Drug Administration approved Voxzogo (vosoritide) injection to improve growth in children five years of age and older with achondroplasia and open epiphyses (growth plates）...
Zydus Cadila gets 180-day exclusivity for Nelarabine injection, announces final approval from US FDA ExpressPharma
November 19, 2021
Zydus Cadila has received final approval from the US Food and Drug Administration (FDA) to market Nelarabine injection 250mg/50ml in the US. Zydus was granted a Competitive Generic Therapy (CGT) designation...
Pfizer seeks EUA for Covid-19 antiviral pill in US Pharmaceutical-Business-Review
November 18, 2021
Pfizer has submitted an application to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) of its investigational oral antiviral drug, Paxlovid (PF-07321332; ritonavir).
FDA approves Besremi to treat rare blood disease EuropeanPharmaceuticalReview
November 17, 2021
The FDA approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.
Lunit Gets FDA Nod for AI-based Chest X-ray Triage Solution, Developed for Sorting of Emergency Cases prnasia
November 16, 2021
Lunit, a leading medical AI provider, today announced it has received US Food and Drug Administration (FDA) 510(k) clearance for its AI-powered chest x-ray triaging solution, 'Lunit INSIGHT CXR Triage'.
FDA Approves Treatment for Rare Blood Disease FDA
November 16, 2021
Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood disease that causes the overproduction of red blood cells.
FDA grants priority review to Boehringer-Lilly’s Jardiance for heart failure Pharmaceutical-Technology
November 15, 2021
Boehringer Ingelheim Pharmaceuticals and Eli Lilly have obtained the US Food and Drug Administration (FDA) priority review for Jardiance (empagliflozin) to potentially treat heart failure...
Pfizer Asks FDA to Approve Booster Shots for All U.S. Adults Drugs
November 11, 2021
As concerns mount that holiday travel and indoor gatherings will foster the spread of COVID-19, Pfizer on Tuesday asked the U.S. Food and Drug Administration to approve booster shots...
INOVIO Receives U.S. FDA Authorization to Proceed with INNOVATE Phase 3 Segment for its COVID-19 Vaccine Candidate, INO-4800, in the U.S. prnewswire
November 10, 2021
INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to help protect people from infectious diseases and treat cancer...
Electronic Drug Registration and Listing Instructions FDA
November 10, 2021
There are three steps, or submissions, that are needed to register an establishment and list a drug with FDA. Each of these steps requires an initial submission followed by periodic updates...

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