Drug Approval

All articles by Drug Approval

FDA approves Eli Lilly’s Alzheimer’s drug donanemab under brand name Kisunla
FDA approves Eli Lilly’s Alzheimer’s drug donanemab under brand name Kisunla
Jack O'Brien
July 2, 2024
2:23 pm

The regulatory greenlight comes less than a month after an FDA advisory committee unanimously backed the drug for approval.

BI exec underscores what FDA approval of Spevigo means for GPP care
BI exec underscores what FDA approval of Spevigo means for GPP care
Jack O'Brien
March 27, 2024
4:26 pm

With approval in hand, Boehringer Ingelheim is now pivoting its efforts to educating patients, healthcare providers and prescribers as well as increasing awareness of GPP in general.

Merck’s Winrevair earns FDA approval in milestone moment for PAH treatment
Merck’s Winrevair earns FDA approval in milestone moment for PAH treatment
Lecia Bushak
March 27, 2024
1:50 pm

The FDA approval marks a milestone for Merck, which acquired the pulmonary arterial hypertension treatment in 2021 through its $11.5 billion buyout of Acceleron Pharma.

Tagrisso plus chemo approved in U.S. for lung cancer
Tagrisso plus chemo approved in U.S. for lung cancer
Marc Iskowitz
February 21, 2024
10:00 am

The FDA greenlit the Tagrisso/chemo regimen in treatment-naive EGFR-mutant NSCLC, bolstering AstraZeneca’s flagship brand against would-be rivals.

More schools stock overdose reversal meds, but others worry about stigma
More schools stock overdose reversal meds, but others worry about stigma
Rae Ellen Bichell and Virginia Garcia Pivik, KFF Health News
October 3, 2023
3:00 pm

The federal Substance Abuse and Mental Health Services Administration recommends that schools, including elementary schools, keep naloxone on hand as fatal opioid overdoses rise.

FDA greenlights Jardiance for treating chronic kidney disease
FDA greenlights Jardiance for treating chronic kidney disease
Jack O'Brien
September 22, 2023
10:43 am

The approval comes weeks after the Biden administration announced Jardiance was among the first 10 prescription drugs selected for Medicare price negotiations under the Inflation Reduction Act.

FDA grants approval to Ipsen for ultra-rare bone disease drug
FDA grants approval to Ipsen for ultra-rare bone disease drug
Jack O'Brien
August 17, 2023
11:01 am

Ipsen heralded the greenlight of the treatment, which reduces new, abnormal bone formation in soft and connective tissues for people living with FOP.

GSK’s Jemperli tops Merck’s Keytruda in frontline endometrial cancer approval
GSK’s Jemperli tops Merck’s Keytruda in frontline endometrial cancer approval
Marc Iskowitz
August 2, 2023
3:01 pm

Jemperli, the PD-1 agent grabbed coveted first-to-market status in 2 patient populations within the tumor type.

FDA grants Leqembi full approval in watershed moment for Alzheimer’s care
FDA grants Leqembi full approval in watershed moment for Alzheimer’s care
Jack O'Brien
July 6, 2023
4:50 pm

The widely expected approval comes six months to the day after the FDA gave Leqembi the greenlight through its accelerated pathway program.

Amneal’s long-acting Parkinson’s drug gets cold shoulder from FDA
Amneal’s long-acting Parkinson’s drug gets cold shoulder from FDA
Marc Iskowitz
July 5, 2023
1:48 pm

The FDA is seeking more pharmacokinetic data from Amneal on compound IPX203 for treating Parkinson’s disease.

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