On Dec. 1, 2017, the U.S. Food and Drug Administration (FDA) approved Mylan’s Ogivri (trastuzumab-dkst) as a biosimilar…
On Nov. 16, 2017, the the U.S. Food and Drug Administration (FDA) approved the Genentech drug Hemlibra (emicizumab-kxwh)…
On Nov. 9, 2017, Dynavax Technologies announced that the U.S. Food and Drug Administration (FDA) had approved HEPLISAV-B…
On Oct. 23, 2017, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) had approved Shingrix (Zoster Vaccine…
On Aug. 30, 2017, the U.S. Food and Drug Administration (FDA) approved Kymriah (tisagenlecleucel) for certain pediatric and…
On Aug. 24, 2017, Adamas announced U.S. Food and Drug Administration (FDA) approval of GOCOVRI as First and…
On Aug. 7, 2017, Seqirus announced that the accelerated development of cell-based manufacturing technology at its state-of-the-art manufacturing…
On Jun. 29, 2017, the U.S. Food and Drug Administration (FDA) unveiled a strategic plan to completely eliminate…
On Jun. 7, 2017 the FDA approved Endari (L-glutamine oral powder) for patients age five years and older…
On Mar. 28, 2017, Genentech drug Ocrevus (ocrelizumab) was approved by the U.S. Food and Drug Administration (FDA)…
On Jan. 3, 2017, the U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) announced the conditional…
On Nov. 18, 2016, the U.S. Food and Drug Administration (FDA) approved extending the age range for use…
On Oct. 27, 2016, Roswell Park Cancer Institute announced it had received authorization from the U.S. Food and…
On Oct. 18, 2016, the U.S. Food and Drug Administration (FDA) approved TECENTRIQ® (atezolizumab) for the treatment of…
On Aug. 29, 2016, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved AFLURIA® QUADRIVALENT…
On Aug. 19, 2016, InBios announced that it had received an Emergency Use Authorization (EUA) from the U.S….
On Jul. 12, 2016, Pfizer announced that Prevnar 13ﾮ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received FDA…
On Jun. 15, 2016, the FDA approved revisions in the package insert for YF-Vax to reflect changes to…
On Jun. 10, 2016, the U.S. Food and Drug Administration (FDA) approved Vaxchora, a vaccine for the prevention…
On May 27, 2016, the Food and Drug Administration (FDA) announced it had amended its labeling regulations for…
On Apr. 29, 2016, GlaxoSmithKline Biologicals in Research Triangle Park, North Carolina, received U.S. Food and Drug Administration…
On Jun. 14, 2016, the FDA approved changes to vaccine administrationﾠschedule for Trumenba vaccine produced by Wyeth Pharmaceuticals,…
On Apr. 11, 2016, the U.S. Food and Drug Administration (FDA) announced that it had granted accelerated approval…
On Dec. 14, 2015, the FDA expanded Merck’s Gardasil 9 licensure to include males age 16ﾖ26 years. The…
On Dec. 11, 2015, Genentech announced that it’s drug Alecensa (alectinib) was approved by the U.S. Food and…
On Nov. 25, 2015, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved Fluad™ (Influenza…
On Nov. 19, 2015, AquaBounty Technologies announced the U.S. Food and Drug Administration (FDA) had approved the Company’s…
On Nov. 10, 2015, Genentech announed that its drug Cotellic (cobimetinib) was approved by the U.S. Food and…
On Sept. 4, 2015, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices…
On Apr. 29, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved Kybella, an injection…