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Submissions and Approvals
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Gilead Resubmits NDA for Lenacapavir Following Complete Response Letter

June 30, 2022

Gilead is seeking approval of lenacapavir for treatment of HIV-1 infection in heavily treatment-experienced individuals with multi-drug resistant HIV-1 infection. Read More

EU Expands Approval of Novartis’ Cosentyx for Pediatric Arthritis

June 29, 2022

Cosentyx, a human interleukin-17A antagonist, is also FDA-approved. Read More

CHMP Recommends Nine New Drugs in Latest Monthly Meeting

June 27, 2022

The European Medicines Agency (EMA)’s human medicines committee endorsed nine new drugs during its June meeting, including Valneva’s adjuvanted COVID-19 vaccine for use in people age 18 to 50 years. Read More

Novartis’ Tabrecta Gained EU Approval for Advanced NSCLC

June 24, 2022

In May 2020, the oral kinase inhibitor received accelerated approval from the FDA. Read More

FDA Grants Accelerated Approval to Novartis’ Tafinlar and Mekinist Combination

June 24, 2022

The combination treatment led to overall response rates of up to 80 percent. Read More

FDA Expands Approval to Merck’s Vaxneuvance Vaccine in Children From Six Weeks to 17 Years Old

June 23, 2022

Vaxneuvance was first approved by the FDA in July 2021 for adults age 18 years and older. Read More

FDA Expands AbbVie’s Skyrizi Approval to Include Crohn’s Disease

June 21, 2022

The approval was supported by results from three pivotal studies. Read More

EU Launches Rolling Review of Pfizer’s Updated COVID-19 Vaccine

June 17, 2022

The companies also plan to begin submitting data supporting a variant-adapted vaccine to the FDA in the coming weeks. Read More

FDA Approves Alnylam’s Amvuttra for hATTR Amyloidosis Polyneuropathy

June 15, 2022

The approved indication for Amvuttra requires an injection treatment in patients once every three months. Read More

Canada Approves Amylyx’s ALS Drug Albrioza

June 14, 2022

The conditional approval was based on results of a phase 2 study. Read More

EU Grants Conditional Marketing Authorization to Roche’s Lunsumio for Follicular Lymphoma

June 10, 2022

Lunsumio demonstrated high complete response rates in a phase 1/2 study. Read More

Veru Submits EUA for Treatment of COVID-19 Hospitalized Patients

June 9, 2022

Sabizabulin demonstrated a 55.2 percent reduction in deaths relative to the untreated cohort. Read More

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