Pharmaceutical News – Page 25 – Global Reach Health

December 13, 2022

Biosimilar Idacio receives FDA Approval

December 13, 2022 – Idacio (adalimumab-aacf), a tumor necrosis factor (TNF) blocker biosimilar to Humira, has been approved by the FDA for the treatment of rheumatoid arthritis

December 12, 2022

FDA approves Krazati (adagrasib) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRASG12C mutation

December 12, 2022 – The FDA has granted accelerated approval to Mirati Therapeutics’ Krazati (adagrasib)

November 18, 2022

FDA Approves Monday/Wednesday/Friday Intramuscular Dosing Schedule for
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)

November 18, 2022 - Jazz Pharmaceuticals plc announced the FDA approval of a supplemental Biologics License Application

July 19, 2022

FDA Approves First Therapy for Repigmentation in Vitiligo

July 19, 2022 – Incyte's Opzelura^TM (ruxolitinib) cream has been approved for the topical treatment of nonsegmental vitiligo in patients who are at least 12 years old.

July 15, 2022

Zonisade Approved to Treat Seizures

July 15, 2022 – Zonisade^TM (zonisamide oral suspension) has received FDA approval to provide adjunctive therapy for the treatment of partial onset seizures in patients

July 14, 2022

Xalkori Granted New Indication to Treat Non-Cancerous Tumors

July 14, 2022 – Pfizer’s Xalkori® (crizotinib) has received a new indication to treat unresectable, recurrent, or refractory ALK-positive inflammatory yofibroblastic

July 14, 2022

Diacomit Approved for Broader Age Group

July 14, 2022 – Diacomit^® (stiripentol) is now indicated for use with clobazam to treat seizures associated with Dravet syndrome in patients at least six months of age and

July 13, 2022

FDA Authorizes Additional COVID-19 Vaccine

July 13, 2022 – The FDA has granted emergency use authorization to Novavax’s COVID-19 vaccine for the prevention of COVID-19 caused by the SARS-CoV-2 virus in adults.