Tag: Product approvals
Russia approves single-dose version of Sputnik V vaccine
MOSCOW — Russian authorities gave regulatory approval Thursday to a single-dose version of the country's Sputnik V vaccine, arguing that the move could accelerate...
EU drug regulator evaluating Pfizer vaccine for youngsters
AMSTERDAM — The European Union's drug regulator said Monday it has begun evaluating a request by Pfizer Inc. and BioNTech to extend approval of...
Pfizer, BioNTech seek COVID vaccine authorization for kids
LONDON — Pfizer Inc. and BioNTech have submitted a request to the European drug regulator for the approval of their coronavirus vaccine to be...
US approves high-dose opioid reversal nasal spray from Hikma
U.S. regulators on Friday approved the first high-dose nasal spray for reversing opioid overdoses.
...
Brazil regulator rejects Sputnik vaccine; Russia cries foul
RIO DE JANEIRO — Brazil's health regulator cited safety concerns while rejecting several states' requests to import almost 30 million doses of Russia's Sputnik...
FDA to scrutinize unproven cancer drugs after 10-year gap
WASHINGTON — Each year the U.S. approves dozens of new uses for cancer drugs based on early signs that they can shrink or slow...
Russian President Putin gets 2nd COVID-19 vaccine shot
MOSCOW — Russian President Vladimir Putin said Wednesday he got his second COVID-19 vaccine shot, three weeks after getting the first dose.
...
FDA OKs first new ADHD drug in over a decade for children
U.S. regulators have approved the first new drug in over a decade for children with ADHD, which causes inattention, hyperactivity and impulsivity.
...
EXPLAINER: What’s a SPAC, the latest craze on Wall Street?
CHARLOTTE, N.C. — WeWork will finally go public this year, allowing investors to buy and sell its shares. But not through a traditional IPO.
...
Pandemic puts pause on on-site use for some Alaska pot shops
JUNEAU, Alaska — Regulators amid much fanfare in early 2020 approved two cannabis lounges in Alaska, making it one of the few states where...