Biden ad­min­is­tra­tion lawyers on Fri­day told a dis­trict court to hold off on de­cid­ing a ma­jor abor­tion pill case un­til De­cem­ber be­cause the FDA may re­move a decades-old pro­hi­bi­tion on dis­pens­ing such pills via mail.

While not­ing that the FDA tem­porar­i­ly lift­ed the in-per­son re­quire­ments dur­ing the pan­dem­ic last month, the Jus­tice De­part­ment lawyers said the FDA is now re­view­ing the risk eval­u­a­tion and mit­i­ga­tion strat­e­gy for the abor­tion pill, known as Mifeprex (mifepri­s­tone). The lawyers said they would pro­vide an up­date on the FDA’s progress by No­vem­ber.

The Amer­i­can Civ­il Lib­er­ties Union, which orig­i­nal­ly sued the fed­er­al gov­ern­ment in 2017 to ex­pand ac­cess to the abor­tion drug and to re­move cum­ber­some rules that might re­strict ac­cess to it, and the Amer­i­can Col­lege of Ob­ste­tri­cians and Gy­ne­col­o­gists both praised the an­nounced move by the FDA.

BREAK­ING: The FDA agreed to con­duct a re­view of its re­stric­tions on mifepri­s­tone, a med­ica­tion used for ear­ly abor­tion and mis­car­riage care.

Af­ter four years of lit­i­ga­tion, this is long over­due, but a ma­jor move for­ward.

— ACLU (@ACLU) May 7, 2021

We are thrilled that the @US_FDA is con­duct­ing a new, ev­i­dence-based re­view of the bur­den­some, un­nec­es­sary REMS re­quire­ments for #mifepri­s­tone, in­clud­ing the in-per­son dis­pens­ing re­quire­ment that is cur­rent­ly on pause due to ad­vo­ca­cy and lit­i­ga­tion from @ACOG. 1/

— ACOG Ac­tion (@ACO­GAc­tion) May 8, 2021

The fed­er­al court has yet to de­cide if it will grant the stay un­til the FDA com­pletes its re­view.

Mean­while, 19 states now re­quire that a clin­i­cian be phys­i­cal­ly present when the abor­tion drug is ad­min­is­tered, there­by pro­hibit­ing the use of telemed­i­cine to pre­scribe med­ica­tion for abor­tion re­mote­ly, ac­cord­ing to the Guttmach­er In­sti­tute.

But the FDA’s cur­rent pause in re­strict­ing ac­cess to the abor­tion pill via mail may al­so gen­er­ate new da­ta on whether it’s safe.

In an­nounc­ing the pre­vi­ous change dur­ing the pan­dem­ic, FDA act­ing com­mis­sion­er Janet Wood­cock said that based on a re­view of the med­ical lit­er­a­ture, there does not ap­pear to be “in­creas­es in se­ri­ous safe­ty con­cerns (such as he­m­or­rhage, ec­topic preg­nan­cy, or sur­gi­cal in­ter­ven­tions) oc­cur­ring with med­ical abor­tion as a re­sult of mod­i­fy­ing the in-per­son dis­pens­ing re­quire­ment dur­ing the COVID-19 pan­dem­ic.”

If court chal­lenges make their way to the Supreme Court again, the ide­o­log­i­cal split on the top court may cre­ate is­sues for those seek­ing to ex­pand ac­cess to mifepri­s­tone.

Last Jan­u­ary, pri­or to the FDA’s an­nounce­ment, the Supreme Court came to a 6-3 de­ci­sion to stop a low­er court from waiv­ing the FDA rules that would’ve al­lowed for the dis­tri­b­u­tion of the abor­tion pills by mail dur­ing the pan­dem­ic.

The FDA today approved Emergent BioSolutions’ Narcan brand naloxone nasal spray for over-the-counter sales. The nod was expected and comes on the heels of a unanimous 19-0 advisory committee vote in favor of approval last month.

The move to OTC means the opioid overdose reversal agent will now be available on grocery, convenience and gas stations shelves, as well as potentially for purchase online.

The mRNA player Moderna is further cementing its presence on the African continent.

Moderna announced on Thursday that it has finalized an agreement with Kenya’s government to partner up and bring an mRNA manufacturing facility to the east African nation. The new facility aims to manufacture up to 500 million doses of vaccines annually. Moderna also said the new facility will have the ability to spike its production capabilities to respond to public health emergencies on the continent or globally.

When Vigil Neuroscience filed its IPO papers in late 2021, the biotech revealed that the FDA had just cleared its Phase I trial — but with a partial clinical hold that limited dosing to under a certain level.

More than a year later, the FDA has lifted the hold.

Vigil is now free to dose VGL101, an antibody targeting TREM2, at levels higher than 20 mg/kg in its ongoing and future clinical trials in patients with adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP), an inherited condition that affects the brain and spinal cord.