Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
FDA publishes revised MAPP, Consolidation of ANDAs by the Office of Generic Drugs
This MAPP describes the process for reviewing and approving or denying requests to consolidate previously approved ANDAs submitted…
EU, CureVac may sign deal for 225 million doses of COVID-19 vaccine
CureVac said it could start large-scale human trials on its vaccine in the last quarter of this year based on results of its…
Brinton Pharma gets DCGI nod for Faviton 400 mg
It will be available across all COVID-19 treatment centres at Rs 79 per tab
Jan Aushadhi stores selling branded generics instead of pure generics: Karnataka Pharmacists…
The association has also raised concerns about the sale of medicines in the absence of registered pharmacists which may lead to…
Stempeutics’ allogeneic cell therapy gets DCGI approval, Cipla to market and distribute…
Indicated for the treatment of CLI due to Buerger’s Disease and Atherosclerotic Peripheral Arterial Disease, it is the first…
FDA publishes temporary guidance on manufacturing, supply chain, product inspections during COVID-19
It provides information regarding common questions related to inspections for facilities manufacturing pharma products and sites…
J&J to buy Momenta in $6.5 bn deal
The acquisition will bolster J&J’s portfolio of drugs for autoimmune diseases
US FDA declines approval for Gilead’s rheumatoid arthritis drug, Filgotinib
The US drug regulator has issued a complete response letter requesting data from the MANTA and MANTA-RAy studies and expressing…
Emergency authorisation for COVID-19 vaccine possible if government decides: ICMR
Normally the final trial takes about six to nine months
Mylan announces launch of generic version of Biogen’s Tecfidera
Dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (MS)