Specialty Drug Pipeline Reviews to help you
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Our current collection of specialty drug pipeline reviews available to Drug Alerts subscribers includes:

Trastuzumab (Herceptin®) Biosimilars

Original FDA Approval: September 25, 1998
Last Updated: February 26, 2018

Tildrakizumab-asmn (Ilumya™)

Original FDA Approval: March 20, 2018
Last Updated: February 28, 2018

Ibalizumab-uiyk (Trogarzo™)

Original FDA Approval: March 6, 2018
Last updated: March 6, 2018

Erenumab-aooe (Aimovig™)

Original FDA Approval: May 17, 2018
Last Updated: March 9, 2018

Burosumab-twza (Crysvita®)

Original FDA Approval: April 17, 2018
Last Updated: March 14, 2018

Volanesorsen (Waylivra)

Complete Response Letter: August 27, 2018
Last Updated: July 25, 2018

Mogamulizumab-kpkc
(Poteligeo ®)

Original FDA Approval: August 8, 2018
Last Updated: August 10, 2018

Patisiran (Onpattro™)

Original FDA Approval: August 10, 2018
Last Updated: August 13, 2018

Lanadelumab-flyo (Takhzyro™)

Original FDA Approval: August 23, 2018
Last Updated: August 27, 2018

Moxetumomab pasudotox-tdfk (Lumoxiti™)

Original FDA Approval: September 13, 2018
Last Updated: September 21, 2018

Fremanezumab-vfrm (Ajovy™)

Original FDA Approval: September 14, 2018
Last Updated: September 24, 2018

Cemiplimab-rwlc (Libtayo®)

Original FDA Approval: September 9, 2018
Last Updated: October 15, 2018

Inotersen sodium (Tegsedi™)

Original FDA Approval: October 5, 2018
Last Updated: October 16, 2018

Pegfilgrastim-cbqv (Udenyca™)

Original FDA Approval: November 2, 2018
Last Updated: November 5, 2018

Venetoclax (Venclexta ®)

Original FDA Approval: April 11, 2016
Last Updated: January 17, 2019

Sacituzumab Govitecan

Complete Response Letter: January 17, 2019
Last Updated: January 17, 2019

Calaspoagase Pegol-mknl (Asparlas™)

Original FDA Approval: December 20, 2018
Last Updated: February, 4 2019

Tagraxofusp-erzs (Elzonris™)

Original FDA Approval: December 21, 2018
Last Updated: February, 4 2019

Nivolumab + Ipilimumab (Opdivo® + Yervoy®)

Original FDA Approval: September 30, 2015
Last Updated: February 11, 2019

Caplacizumab (Cablivi™)

Original FDA Approval: February 6, 2018
Last Updated: February 20, 2019

Tipiracil hydrochloride + Trifluridine (Lonsurf®)

Original FDA Approval: September 22, 2015
Last Updated: February 28, 2019

Olaparib (Lynparza®)

Original FDA Approval: December 12, 2014
Last Updated: February 29, 2019

Atezolizumab (Tecentriq®)

Original FDA Approval: May 18, 2016
Last Updated: March 20, 2019

Siponimod (Mayzent®)

Original FDA Approval: March 26, 2019
Last Updated: March 26, 2019

Romosozumab-aqqg (Evenity™)

Original FDA Approval: April 9, 2019
Last Updated: April 9, 2019

Immune Globulin Intravenous, Human (ASCENIV™)

Original FDA Approval: April 1, 2019
Last Updated: April 12, 2019

Quizartinib

PDUFA: August 25, 2019
Last Updated: April 17, 2019

Risankizumab-rzaa (Skyrizi™)

Original FDA Approval: April 23, 2019
Last Updated: April 25, 2019

Ado-trastuzumab emtansine (Kadcyla®)

Original FDA Approval: February 22, 2013
Last Updated: May 9, 2019

Aflibercept (Eylea®)

Original FDA Approval: November 18, 2011
Last Updated: May 16, 2019

Ivosidenib (Tibsovo®)

Original FDA Approval: August 21, 2018
Last Updated: May 16, 2019

Onasemnogene abeparvovec-xioi (Zolgensma®)

Original FDA Approval: May 24, 2019
Last Updated: May 24, 2019

Ruxolitinib phosphate (Jakafi®)

Original FDA Approval: November 16, 2011
Last Updated: May 24, 2019

Lenalidomide (Revlimid®)

Original FDA Approval: December 27, 2005
Last Updated: May 28, 2019

Avelumab (Bavencio®)

Original FDA Approval: March 23, 2017
Last Updated: May 30, 2019

Galcanezumab-gnlm (Emgality®)

Original FDA Approval: September 27, 2018
Supplemental Approval: June 04, 2019

Tafamidis meglumine (Vyndaqel®)

Original FDA Approval: May 3, 2014
Last Updated: June 11, 2019

Selinexor (Xpovio™)

Original FDA Approval: July 3, 2019
Last Updated: June 11, 2019

Polatuzumab vedotin-piiq (Polivy™)

Original FDA Approval: June 10, 2019
Last Updated: June 11, 2019

Celiprolol (Edsivo™)

Complete Reponse Letter: June 25, 2019
Last Updated: June 25, 2019

Avatrombopag (Doptelet®)

Original FDA Approval: May 21, 2019
Last Updated: June 26, 2019

Eculizumab (Soliris®)

Original FDA Approval: March 16, 2007
Last Updated: June 28, 2019

Dupilumab (Dupixent®)

Original FDA Approval: March 28, 2017
Last Updated: July 3, 2019

Afamelanotide acetate (Scenesse®)

PDUFA: October 6, 2019
Last Updated: July 3, 2019

Golodirsen

PDUFA: August 19, 2019
Last Updated: July 17, 2019

Riluzole

Original FDA Approval: December 21, 1995
Last Updated: July 20, 2019

Apremilast (Otezla®)

Original FDA Approval: March 21, 2014
Last Updated: July 23, 2019

Rituximab (Rituxan®) Biosimilars

Original FDA Approval: November 26, 1997
Last Updated: July 23, 2019

Pembrolizumab (Keytruda®)

Original FDA Approval: September 4, 2014
Last Updated: July 31, 2019

OnabotulinumtoxinA (Botox®)

Original FDA Approval: April 12, 2002
Last Updated: August 2, 2019

Pexidartinib hydrochloride

Original FDA Approval: August 2, 2019
PDUFA: August 3, 2019

AV-001

PDUFA: December 15, 2019
Last Updated: August 12, 2019

Daratumumab (Darzalex®)

Original FDA Approval: November 16, 2015
Last Updated: August 12, 2019

Teriparatide

Original FDA Approval: November 26, 2002
Last Updated: August 15, 2019

Entrectinib (Rozlytrek)

Original FDA Approval: August 15, 2019
Last Updated: August 19, 2019

Fedratinib

Original FDA Approval: August 16, 2019
Last Updated: August 19, 2019

Upadacitinib

Original FDA Approval: August 16, 2019
Last Updated: August 19, 2019

Ravulizumab-cwvz (Ultomiris™)

Original FDA Approval: December 21, 2018
Last Updated: August 27, 2019

Brolucizumab

PDUFA: October 15, 2019
Last Updated: August 27, 2019