Branded

FDA approves new indication for Regeneron, Sanofi’s Dupixent

Dupixent is now approved as an add-on maintenance treatment for patients ages 6 to 11 years old with moderate to severe asthma.
FDA OKs new indication for Roche’s Tecentriq

Tecentriq is the first and only cancer immunotherapy approved for NSCLC in the adjuvant setting, the company said.

Adamis secures FDA nod for Zimhi

Zimhi is a high-dose naloxone product for the treatment of opioid overdose.
FDA approves new indication for Gilead’s Biktarvy

The approval expands the indication for Biktarvy to include young children living with HIV-1 infection.
Ascendis Pharma intros Skytrofa

Skytrofa is the first and only FDA-approved, once-weekly treatment for pediatric growth hormone deficiency.
Eli Lilly’s Verzenio obtains new indication

Verzenio is the first and only CDK4/6 inhibitor approved for certain people with HR-positive, HER2-negative high risk early breast cancer.
Merck, Ridgeback seeks FDA emergency use clearance for COVID-19 treatment

If approved, molnupiravir would be the first oral antiviral pill for the treatment of mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.
Merck’s molnupiravir effective in reducing hospitalization, death for patients with moderate COVID-19

If authorized by the Food and Drug Administration, molnupiravir could be the first oral antiviral medicine for COVID-19.
FDA gives AbbVie approval for Qulipta

Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist (gepant) specifically developed for the preventive treatment of migraine.
Lilly expands affordability of Insulin Lispro Injection

Lilly's Insulin Lispro Injection, 100 units/ml, will now have a 70% lower list price than Humalog U-100, starting Jan. 1, 2022.
Impel NeuroPharma intros migraine treatment Trudhesa

Trudhesa is launching with an end-to-end process meant to offer savings and home delivery of the treatment for acute migraines.
Incyte wins FDA nod for Opzelura

Opzelura is the first and only topical formulation of a Janus kinase inhibitor approved in the United States.
Scynexis debuts Brexafemme

Brexafemme is the first and only oral non-azole prescription medication approved by the FDA to treat vaginal yeast infection.
Upsher-Smith partners with Cove to expand access to Tosymra for migraine

Upsher-Smith's migraine medication Tosymra will now be offered through Cove's telemedicine platform.

News and information on branded drugs sold in retail pharmacies, as well as their suppliers.