FDA Approvals

Combination pack approved for breast cancer treatmentFDA approves ribociclib plus letrozole to treat a subset of advanced breast cancer patients.
FDA expands cystic fibrosis treatmentFDA expanded the use of ivacaftor (Kalydeco, Vertex Pharmaceuticals) to treat cystic fibrosis.
Immuno-oncology bladder drug wins approvalSoon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio) for locally advanced or metastatic urothelial carcinoma.
Costly new ALS treatment approvedFDA recently approved the first new treatment for amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease, in more than 20 years.
FDA approves first targeted leukemia drug for certain patients, plus 2 moreLate last week, FDA approved a new drug to treat acute myeloid leukemia (AML), the first treatment for Batten disease, and expanded the use of a current drug to treat liver cancer.
New abuse-deterrent opioid availableA new abuse-deterrent painkiller - oxycodone hydrochloride (RoxyBond, Inspirion Delivery Services) - will be available soon after receiving FDA approval.
FDA clears second Remicade biosimilarIn what is expected to produce hefty saving for rheumatoid arthritis patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).
Hep C drugs approved for kidsFDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
Novel drug approved for Huntington's symptomFDA recently approved deutetrabenazine (Austedo, Teva Pharmaceuticals) to treat chorea associated with Huntington’s disease (HD). The medication is only the second product approved to treat HD, and is the first deuterated product approved by FDA.
First progressive MS drug carries high price tagWhile FDA just approved the first drug for primary progressive multiple sclerosis (PPMS), the drug’s price tag is controversial.