Tag: FDA
FDA Panel Recommends Making Opioid Overdose Antidote Available Over the Counter
An FDA advisory panel has recommended that naloxone, a medication used to reverse opioid overdoses, be made available over the counter. The move is...
Lilly scores FDA emergency authorization for Olumiant in COVID-19, its 2nd...
While the list of authorized medicines to treat COVID-19 remains quite short, with a new nod this week, Eli Lilly stands alone in having two therapeutic offerings.
Lilly’s...
Gilead won a valuable FDA voucher with its Veklury approval, but...
Gilead Sciences has the most successful COVID-19 drug so far in Veklury, an antiviral also known as remdesivir that was originally developed through research programs into hepatitis C and respiratory syncytial virus....
Watch out, Merck: FDA grants Regeneron, Sanofi’s Libtayo priority review for...
One month after Regeneron and Sanofi posted impressive data from a phase 3 trial of their PD-1 inhibitor Libtayo in first-line non-small cell lung...
Agios’ Tibsovo has an FDA green light in AML. Why did...
Agios may have persuaded the FDA into doling out an approval for its acute myeloid leukemia (AML) drug Tibsovo based on phase 1 results,...
Amid Regeneron’s emergency use bid, former FDA chief says US ‘too...
Days removed from its star turn in President Donald Trump's COVID-19 treatment, Regeneron's antibody cocktail could be on the fast track to an emergency...
Intercept cuts 25% of workforce after NASH rejection from FDA
After a surprise rejection from the FDA derailed Intercept’s plans to launch the first nonalcoholic steatohepatitis (NASH) drug, the company is cutting its workforce.
In a Securities and Exchange...
AstraZeneca eyes less-frequent Imfinzi dosing with FDA ‘priority’ boost
Merck’s Keytruda recently became the only member of the PD-1/PD-L1 class with an FDA nod for less-frequent dosing—but AstraZeneca doesn’t intend to let it...
Jazz’s Xywav, a low-sodium alternative to blockbuster Xyrem, snags FDA nod...
Jazz Pharmaceuticals’ Xyrem has become the standard of care for two symptoms of narcolepsy since its FDA approval in 2002. But the company’s introducing...
AstraZeneca scores speedy FDA review for Farxiga based on ‘innovative’ heart...
AstraZeneca has already taken impressive Farxiga heart failure outcomes results and parlayed them into a watershed approval. Looking at Farxiga's future in a competitive...
