Searched for
EU DRUG REGULATOR
Eli Lilly's Alzheimer's drug donanemab approved in India, but neurologists flag cost, access barriersA new drug for Alzheimer's, donanemab, has arrived in India. It aims to slow the disease's progression by clearing brain plaques. While off...- India’s rising export champion faces a critical credibility testIndia's seafood exports are soaring, reaching record highs and aiming for $30 billion within five years. Despite overcoming US tariffs and ...
- Banned substance in shrimp: Vet shops under close watchIndia's top drug regulator is cracking down on veterinary shops. This action follows a significant rejection of shrimp exports to major mar...
- India waives clinical trial requirement for drugs approved in developed marketsIndia has waived clinical trial requirements for new drugs with significant therapeutic advances that have been approved in the US, UK, Jap...
- EU-approved medical devices' imports may be easedThe Indian government is considering exempting medical devices approved in the European Union from clinical investigation requirements, sim...
- European Union's drug regulator green lights Pfizer's COVID-19 pillThe endorsement by the European Medicines Agency (EMA) allows EU member states to deploy the drug after the regulator gave guidance for its...
- EU drug regulator starts reviewing new coronavirus vaccineA rolling review is an accelerated way of assessing new drugs that allows European Medicine Agency experts to look at data from ongoing stu...
- Europe eyes arthritis drug for Covid-19 casesEU drug regulator said that it was assessing an application to extend the use of tocilizumab for adults suffering from severe coronavirus i...
- No application for Covishield yet: EU drug regulatorThe EMA website lists four vaccines as under rolling review — Sputnik V, Covovax, CureVac and Sinovac. An SII executive who is familiar wit...
- EU drug regulator evaluating Pfizer vaccine for youngstersIn a statement Friday, the two pharmaceuticals said their request is based on an advanced study in more than 2,000 adolescents that showed ...
- USFDA nod for cancer biosimilar is a big triumph: Kiran Mazumdar ShawAfter initial hiccups with the US and EU drug regulators, Shaw said this approval signifies India and her company’s capability in developin...
- Germany suspends marketing of 54 drugs tested by GVK BiosciencesGermany's drug regulator has suspended the marketing of 54 medicines clinically tested by India's GVK Biosciences in compliance.
- EU bans 700 generic drugs for manipulation of trials by GVK BiosciencesMedicines affected by the sales ban will lose their validity for use in the EU and they should no longer be sold by pharmaceutical companie...
- German regulator hails European Medicine Agency's drugs suspension on GVK Bio dataThe German watchdog said it will take a decision shortly on whether to add more medicines to the list of banned drugs in the wake of the EM...
- Ranbaxy gains over 2% as EU lifts export ban on Toansa unitThe European drug regulator has said that drugs from the Ranbaxy’s Toansa unit are fine. The regulator also said that the corrective measur...
- Ranbaxy drugs safe says Australian drug regulator"At present, there is no evidence that any of the products in the Australian market manufactured by Ranbaxy are of an unacceptable quality".
- UK drug regulator reviewing Ranbaxy's regulatory issuesThe UK drug regulator is reviewing Ranbaxy regulatory issues in the light of recent revelations to see whether the situation warrants any a...
- Drug Controller General of India to inspect bulk drug plants exporting to EUDCGI is readying a plan to check if domestic bulk drug facilities that export to the European Union comply with WHO-prescribed norms.
- India to prepare case on drug confiscations at European portsIndia is preparing its case on the repeated seizures at European ports of its consignments containing off-patent drugs meant for other deve...
- India may drag EU to WTO on seizure of drugs in transitIf the European Union does not allow Indian drugs to transit through its customs even after bilateral negotiations, India will drag Brussel...
Load More
