Eli Lilly announced updated data from the positive Phase III monarchE trial evaluating the investigational use of Verzenio (abemaciclib) in combination with standard adjuvant endocrine therapy (ET) for… read more.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the submission of a supplemental Biologics License Application (sBLA) to the FDA seeking expanded approval of Stelara (ustekinumab) to… read more.
Oyster Point Pharma, Inc. announced that the FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye… read more.
Pfizer Inc. and BioNTech SE announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age… read more.
The FDA has approved Qulipta (atogepant tablets), from AbbVie, for the preventive treatment of episodic migraine in adults. The approval of Qulipta was based on findings from the… read more.
ViiV Healthcare has announced it has made a regulatory submission to the FDA for approval of a new dispersible tablet formulation of the fixed dose combination of abacavir,… read more.
Regeneron Pharmaceuticals, Inc. has announced that the FDA has accepted for priority review a Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized… read more.
ChemoCentryx announced that the FDA has approved Tavneos (avacopan), an orally administered selective complement 5a receptor inhibitor, as an adjunctive treatment of adult patients with severe active anti-neutrophil… read more.
Medtronic plc announced it has received CE (Conformité Européenne) Mark for the Hugo robotic-assisted surgery (RAS) system, authorizing the sale of the system in Europe. CE Mark approval… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Artesunate Amivas, intended for… read more.
Celltrion Healthcare announced two data sets relating to the use of the subcutaneous formulation of infliximab, Remsima SC (CT-P13 SC), in inflammatory bowel disease (IBD). The first study… read more.
Real-world data looking at biologic treatment and vaccine hesitancy in psoriasis patients is being presented at EADV’s 30th Congress. The findings of two studies are helping to advance… read more.
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