December 21, 2020
December 21, 2020 – The U.S. FDA has approved expanded indications for three medications from Vertex
Pharmaceuticals that are indicated to treat cystic fibrosis (CF), with patients selected
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December 18, 2020
December 18, 2020 – The U.S. FDA has approved Orgovyx TM (relugolix), manufactured by Myovant
Sciences, as the first oral hormone therapy indicated to treat advanced prostate
December 18, 2020
December 18, 2020 The U.S. FDA has approved a new indication for Tagrisso® (osimertinib),
manufactured by AstraZeneca. The drug is now indicated to provide adjuvant treatment
December 18, 2020
December 18, 2020 – The U.S. FDA has approved a new indication for Xpovio® (selinexor), manufactured by Karyopharm. The drug is now indicated for use in combination with bortezomib and
December 17, 2020
December 17, 2020 – The U.S. FDA has approved RiabniTM (rituximab-arrx), manufactured by Amgen, as
the third biosimilar for Genentech’s Rituxan® (rituximab). Riabni is indicated to treat certain
December 16, 2020
December 16, 2020 – The U.S. FDA has approved MargenzaTM (margetuximab-cmkb), manufactured by
MacroGenics, for use in combination with chemotherapy to treat adults who have
December 15, 2020
December 15, 2020 – The U.S. FDA has approved Klisyri® (tirbanibulin), manufactured by Almirall, to
provide topical treatment of actinic keratosis (AK) on the face or scalp. Klisyri is a novel
December 15, 2020
December 15, 2020 – Morton Grove Pharmaceuticals has issued a voluntary recall of four batches of
Hydroxyzine Hydrochloride (HCl) Oral Solution, USP (Syrup), 10mg/5mL due to an impurity.