Branded

Adamis secures FDA nod for Zimhi

Zimhi is a high-dose naloxone product for the treatment of opioid overdose.
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.
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.

Novartis obtains FDA green light for Scemblix