Drug Approval | December 29, 2021
U.S. FDA approves Leo Pharma’s Adbry
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022
Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022
All the recommendations have been sent to the Drugs Controller General of India (DCGI) for final approval.
The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting permission to manufacture and market anti-Covid pill molnupiravir for restricted emergency use
The product is expected to be available in a week’s time
DCGI approved the drug based on the review of clinical data
The company will market it under the brand name Molflu
The drug will be marketed under the brand name Molnaflu
The Covid-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron
The NMPA approval is based on the positive data of GEMSTONE-302 study, a multi-center, randomized, double-blind, phase III study that evaluated the efficacy and safety of Cejemly or placebo in combination with chemotherapy in first-line stage IV NSCLC patients
First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine
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