Branded

FDA clears Nextstellis from Mayne, Mithra

Nextstellis is the first and only contraceptive pill containing estetrol, a native estrogen, which is produced from a plant source. It is also the first new estrogen to hit the U.S. market in more than 50 years, the company said.
FDA clears Opdivo as first-line gastric cancer treatment

Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.

Novartis receives FDA approval for self-injection of Xolair

With the new offering of self-injection for Xolair, healthcare providers now have an additional administration option for appropriate patients.
Bristol Myers Squibb, bluebird bio receive FDA nod for Abecma

Abecma provides a treatment for adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy.
Gilead Sciences obtains FDA OK for new indication of Trodelvy

Gilead Sciences' Trodelvy now can be used as a treatment in adult patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one of them for metastatic disease.
Jazz Pharmaceuticals gets FDA nod for new indication of Vyxeos

Jazz Pharmaceuticals’ Vyxeos now is approved for the treatment of secondary acute myeloid leukemia in pediatric patients.
ANI expands branded products portfolio with acquisition from Sandoz

ANI is acquiring four dermatology products from Sandoz, which collectively generated net revenues of $13.2 million in 2020.
Supernus receives FDA OK for Qelbree

Supernus' Qelbree offers a novel once a day sprinkleable non-stimulant for children and adolescents with ADHD.
Sanofi’s Sarclisa receives FDA nod for new indication

Sarclisa now is included in two standard of care regimens for the treatment of patients with multiple myeloma, as early as first relapse.
FDA clears new indication, formulation for Astellas’ Myrbetriq

Astellas is bringing forward a new treatment option for children impacted by neurogenic detrusor overactivity, a bladder dysfunction related to neurological impairment.
Merck gets FDA nod for new indication of Keytruda

Merck's Keytruda is now FDA approved as a treatment for esophageal cancer or gastroesophageal junction carcinoma.
Zealand Pharma obtains FDA green light for Zegalogue

Zealand Pharma's Zegalogue injection is a diabetes treatment for children and adults that addresses sudden and severe hypoglycemia.
Journey Medical in-licenses, launches Accutane

Journey Medical is adding Accutane to its portfolio of dermatology products.
Janssen obtains FDA approval for Ponvory

Janssen’s Ponvory is an oral treatment for adults with relapsing forms of multiple sclerosis.

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