TherapeuticsMD Inc. won its first-ever FDA approval as the U.S. drug regulator cleared the women’s healthcare company’s hormone therapy – after rejecting it one year earlier – for a painful condition triggered by menopause.
There were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
Sun Pharmaceutical Industries received approval from the U.S. Food and Drug Administration for Yonsa (abiraterone acetate) to treat metastatic castration-resistant prostate cancer.
U.S. regulators expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation.
Eisai Inc. submitted a supplemental New Drug Application for priority review to the U.S. FDA for the company’s antiepileptic drug Fycompa (perampanel) CIII as monotherapy and adjunctive use.
The U.S. Food and Drug Administration approved Sanofi’s Toujeo (insulin glargine 300 Units/mL) Max SoloStar, the highest capacity long-acting insulin pen that will be available on the market.
Shares of Theratechnologies and TaiMed Biologics jumped after the U.S. Food and Drug Administration green lit Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
The FDA approved a supplemental NDA that expands the use of Sunovion’s Latuda to include treating major depressive episode associated with bipolar I disorder in pediatric patients.
The FDA approved Biktarvy, Gilead’s once-daily, triple-combo tablet for treating HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market.
Ferring Pharmaceuticals Inc. announced that the U.S. FDA approved Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.