Astrazeneca plc, of Cambridge, U.K.

Fasenra Pen (benralizumab)

Monoclonal antibody targeting IL-5 receptor alpha

Severe eosinophilic asthma

FDA approved the self-administration of the drug in a prefilled, single-use auto injector

DBV Technologies SA, of Montrouge, France

Viaskin Peanut

Immunotherapy delivered via once-daily epicutaneous patch

Peanut allergy

FDA accepted for review BLA seeking approval to treat peanut-allergic children, ages 4 to 11; PDUFA date is Aug. 5, 2020; FDA plans to hold an advisory committee meeting

Flavocure Biotech Inc., of Baltimore

Caflanone (FBL-03G)


Pancreatic cancer

FDA granted orphan drug status

Galderma SA, of Lausanne, Switzerland

Aklief (trifarotene)

Topical cream targeting retinoic acid receptor gamma


Approved by FDA

I-Mab Biopharma Co. Ltd., of Shanghai


CD73 antibody

Advanced solid tumors

National Medical Products Administration approved the IND to start clinical trials in China

Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson

Darzalex (daratumumab)

CD38-directed antibody

Multiple myeloma

FDA approved use in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients who are eligible for autologous stem cell transplant

Janssen Pharmaceutical Co., a unit of New Brunswick, N.J.-based Johnson & Johnson


Poly ADP-ribose polymerase inhibitor

Metastatic castration-resistant prostate cancer

FDA granted breakthrough therapy designation for use in patients with BRCA1/2 gene-mutated disease after taxane chemotherapy and androgen receptor-targeted therapy


For more information about individual companies and/or products, see Cortellis.


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