You are here: Industry Insights > FDA

News List

Radius Announces Update on Tymlos (abaloparatide) Label Drugs
December 29, 2021
Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS) today announced that the U.S. Food and Drug Administration (FDA) has approved updates to the Tymlos label, including the removal of the boxed warning regarding the risk of osteosarcoma.
FDA Says Rapid At-Home COVID-19 Tests Not as Sensitive to Omicron drugs
December 29, 2021
Early research suggests that some rapid COVID-19 tests may be less able to detect the omicron variant, the U.S. Food and Drug Administration said Tuesday.
Lupin gets tentative US FDA nod for generic tablets to treat high BP ExpressPharma
December 28, 2021
Lupin recently said it has received tentative approval from the US health regulator for its generic Azilsartan Medoxomil tablets used to treat high blood pressure.
FDA authorizes additional oral antiviral for treatment of COVID-19 in certain adults WorldPharmaNews
December 28, 2021
The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing...
FDA Approves Apretude Drugs
December 27, 2021
ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. (Pfizer) and Shionogi Limited (Shionogi) as shareholders...
Evusheld to prevent Covid-19: There won't be nearly enough for Americans who are eligible FirstWordPharma
December 27, 2021
The US government has only contracted for enough doses of AstraZeneca's Evusheld to cover less than one-tenth the number of people who are eligible for it, reported CNN.
FDA grants EUA for Merck-Ridgeback’s oral Covid-19 antiviral molnupiravir Pharmaceutical-Technology
December 27, 2021
The authorisation is based on positive results from the Phase III MOVe-OUT trial of molnupiravir in adult Covid-19 patients.
FDA grants fast track designation to Eisai-Biogen’s Alzheimer’s therapy Pharmaceutical-Technology
December 27, 2021
The US Food and Drug Administration (FDA) has granted Fast Track designation to Eisai and Biogen’s experimental drug, lecanemab, to treat early Alzheimer’s disease (AD).
FDA grants EUA for Pfizer’s Covid-19 oral antiviral Paxlovid Pharmaceutical-Technology
December 24, 2021
The US Food and Drug Administration (FDA) has granted an emergency use authorization (EUA) for Pfizer’s oral antiviral Paxlovid to treat mild-to-moderate Covid-19 in adults and paediatric individuals aged 12 years and above.
Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 prnewswire
December 23, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease...

Previous page 1 2 3 4 5 6 7 8 9 10 ... 366 367 Next page