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Methylnaltrexone

FDA approved in 2008. … Methylnaltrexone is a pheriphally-acting μ-opioid antagonist that acts on the gastrointestinal tract to decrease opioid-induced constipation without producing analgesic effects or withdrawal symptoms.

Haemagglutinin-strain A(H3N2)

Haemagglutinin-strain A(H1N1)

Secretin human

The hormone is produced from the enterochromaffin cells in the duodenum in response to the duodenal content with the pH less than 4.5 [L1875]. … Purified synthetic human secretin, also referred to as RG1068, is available as an intravenous injection under the market name ChiRhoStim ® in the U.S..

Vanzacaftor

[L52275,A179677] Vanzacaftor was first approved by the US FDA in December 2024 in combination with another CFTR corrector - [tezacaftor], which binds to a different site than vanzacaftor - and [deutivacaftor … It is used alongside other CFTR correctors and CFTR potentiators to increase the quantity and function of CFTR at the cell surface in patients with cystic fibrosis.

Regorafenib

FDA approved on September 27, 2012. Approved use of Regorafenib was expanded to treat Hepatocellular Carcinoma in April 2017. … Regorafenib is an orally-administered inhibitor of multiple kinases.

Zolmitriptan

[A193791] Triptans can be administered alone or in combination with an NSAID like [naproxen], and represent the current "gold standard" for acute migraine treatment. … It is currently available in both tablet and nasal spray forms.[L12978]

Pariglasgene brecaparvovec

continued approval potentially contingent on confirmatory trials. … [L64050] Restoring hepatic G6Pase activity supports the release of glucose during fasting, and in clinical studies reduced patients' reliance on dietary cornstarch used to prevent hypoglycemia.

Enprofylline

Enprofylline is used in asthma, chronic obstructive pulmonary disease, and in the management of cerebrovascular insufficiency, sickle cell disease, and diabetic neuropathy. … Long-term enprofylline administration may be associated with elevation in liver enzyme levels and unpredictable blood levels.

Cenegermin

[L4563] In particular, cenegermin was granted Priority Review designation, under which the FDA’s goal is to take action on an application within six months of application filing where the agency determines … [L4563] While the prevalence of neurotrophic keratitis is low, the impact of this serious condition and its associated sequelae on an individual patient can be debilitating.