The U.S. Food and Drug Administration (FDA) approved Bristol Myers Squibb’s oral heart disease drug, making Camzyos (mavacamten) the first cardiac myosin inhibitor to be permitted for use in the country.

The United States on December 22 authorized Pfizer Inc.’s antiviral Covid-19 pill for people ages 12 and older at risk of severe illness, the first oral and at-home treatment as well as a new tool against the fast-spreading Omicron variant.

Biogen

The European Commission (EC) granted marketing authorization for Biogen Inc.’s Vumerity (diroximel fumarate) to treat adults with relapsing-remitting multiple sclerosis (MS).

Pfizer Inc. started a large study testing the company’s investigational oral antiviral drug for the prevention of Covid-19 infection among those who have been exposed to the virus.

Pfizer announced on Sept. 2 the dosing of the first patients in a Phase III trial assessing a single dose of the company’s investigational RSV bivalent prefusion F subunit vaccine candidate (RSVpreF) in adults ages 60 and older. One day earlier, Pfizer announced the initiation of a Phase II/III clinical study of 1,140 participants for an oral pill expected to be used in a broad population of Covid patients.

Pfizer Inc. started dosing in a mid-to-late-stage trial of the company’s oral antiviral therapy for Covid-19 in non-hospitalized, symptomatic adult patients.

Amylyx Pharmaceuticals announced an infusion of $135 million in Series C funds to support the late-stage development of the Boston-based company’s lead candidate, AMX0035, for amyotrophic lateral sclerosis (ALS). 

Migraine headaches can be reduced in frequency and severity by atopant, an oral therapy developed by AbbVie, according to data presented at the 2021 American Headache Society’s (AHS) Annual Scientific Meeting.

The U.S. Food and Drug Administration approved Aurinia Pharmaceuticals Inc.’s Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis.

The U.S. Food and Drug Administration approved BioCryst Pharmaceuticals Inc.’s Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary angioedema in adults and young patients 12 years and older.