InBios received FDA EUA for its ZIKV Detect IgM Capture ELISA diagnostic test for antibodies in human serum
On Aug. 19, 2016, InBios announced that it had received an Emergency Use Authorization (EUA) from the U.S….
FDA extended the age indication for PCV13 (Prevnar 13) to include adults age 18 through 49 years
On Jul. 12, 2016, Pfizer announced that Prevnar 13ﾮ (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) received FDA…
FDA approved revisions in package insert for YF-Vax reflected changes to International Health Regulations and recommendations
On Jun. 15, 2016, the FDA approved revisions in the package insert for YF-Vax to reflect changes to…
FDA approved Vaxchora for the prevention of cholera
On Jun. 10, 2016, the U.S. Food and Drug Administration (FDA) approved Vaxchora, a vaccine for the prevention…
FDA revised the Nutrition and Supplement Facts Labels
On May 27, 2016, the Food and Drug Administration (FDA) announced it had amended its labeling regulations for…
FDA approved Hiberix for full Hib vaccineﾠ series
On Apr. 29, 2016, GlaxoSmithKline Biologicals in Research Triangle Park, North Carolina, received U.S. Food and Drug Administration…
FDA approved changes to vaccine administrationﾠschedule for Trumenba vaccine
On Jun. 14, 2016, the FDA approved changes to vaccine administrationﾠschedule for Trumenba vaccine produced by Wyeth Pharmaceuticals,…
Genentech drug Venclexta (venetoclax) was approved
On Apr. 11, 2016, the U.S. Food and Drug Administration (FDA) announced that it had granted accelerated approval…
FDA expanded Gardasil 9 licensure to include males age 16ﾖ26 years
On Dec. 14, 2015, the FDA expanded Merck’s Gardasil 9 licensure to include males age 16ﾖ26 years. The…
Genentech drug Alecensa (alectinib) was approved by FDA
On Dec. 11, 2015, Genentech announced that it’s drug Alecensa (alectinib) was approved by the U.S. Food and…
FDA approved new injectable influenza vaccine, Fluad, for use in people age 65 years and older
On Nov. 25, 2015, Seqirus announced that the U.S. Food and Drug Administration (FDA) had approved Fluad™ (Influenza…
The FDA approved AquaBounty Technologies’ application to sell the AquAdvantage genetically engineered salmon
On Nov. 19, 2015, AquaBounty Technologies announced the FDA has approved the Company’s New Animal Drug Application for…
Genentech drug Cotellic (cobimetinib) was approved
On Nov. 10, 2015, Genentech announed that its drug Cotellic (cobimetinib) was approved by the U.S. Food and…
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CDC published updated ACIP recommendations regarding the intervals between PCV13 and PPSV23 vaccines
On Sept. 4, 2015, the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices…
FDA approved injectable drug to eliminate double chin
On Apr. 29, 2015, the U.S. Food and Drug Administration (FDA) announced it had approved Kybella, an injection…
FDA approved the Quadracelﾠ DTaP+IPV ﾠvaccine for use in children age 4-6 years
On Mar. 24, 2015, the U.S. Food and Drug Administration (FDA) approved Sanofi’s Quadracel, a newﾠcombinationﾠDTaP+IPVﾠ vaccine for…
The first biosimilar Zarxio (Filgrastim-sndz) was approved by the FDA
On Mar. 6, 2015, the FDA approved filgrastim-sndz (Zarxio, Sandoz, Inc.), the first biosimilar product available in the…
FDA approved the use of Bexsero, the second vaccine licensed in the U.S. to prevent serogroup B meningococcal disease
On Jan. 23, 2015, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval of…
FDA approved Novo Nordisk’s injection for obesity
On Dec. 23, 2014, Novo Nordisk the FDA approved a formulation of Novo Nordiskﾒs diabetes drug, liraglutide, for…
FDA approved the use of Gardasil 9 HPV vaccine in the US
On Dec. 11, 2014, Merck announced that the FDA had approved GARDASILﾮ9 (Human Papillomavirus 9-valent Vaccine, Recombinant), Merckﾒs…
FDA approved the use of Trumenba in the US to prevent serogroup B meningococcal disease
On Oct. 29, 2014, Pfizer announced the FDA has granted accelerated approval of TRUMENBAﾮ (meningococcal group B vaccine)…
Genentech drug Esbriet (pirfenidone) was approved
On Oct. 15, 2014, Genentech drug Esbriet (pirfenidone) was approved by the U.S. Food and Drug Administration (FDA)…
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CDC published ACIP recommendations for use of PCV13 and PPSV23 vaccines in adults age 65 and older
On Sept. 19, 2014, the Centers for Disease Control and Prevention”s (CDC) Advisory Committee on Immunization Practices (ACIP)…
FDA approved Genentech’s Avastin plus chemotherapy for treatment of advanced cervical cancer
On Aug. 14. 2014, Genentech announced that the U.S. Food and Drug Administration (FDA) had approved Avastin (bevacizumab)…
Omeros received FDA Approval of Omidriaﾙ
On Jun. 2, 2014, Omeros received FDA approval of Omidriaﾙ for use in cataract and other intraocular lens…
FDA lowered age of licensure for Adacel vaccine administration from age 11 years to 10 years
On Apr. 1, 2014, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had expanded the approved…
Genentech drug Gazyva (obinutuzumab) was approved
On Nov. 13, 2013, Genentech announced that it’s drug Gazyva (obinutuzumab) was approved by the U.S. Food and…
FDA extended FluLaval IIV age range to include children and teens age 3ﾖ17 years; licenses quadrivalent FluLaval product
On Aug. 16, 2013, the FDA extended FluLaval IIV (GlaxoSmithKline) age range to include children and teens age…
FDA expanded age indication for Menveo to include infants and toddlers age 2 through 23 months
On Aug. 1, 2013, Novartis announced the U.S. Food and Drug Administration (FDA) had approved Menveo (Meningococcal [Groups…
Genentech drug Kadcyla (ado-trastuzumab emtansine) was approved
On Feb. 22, 2013, the U.S. Food and Drug Administration (FDA) announced they had approved Genentech’s licensed ado-trastuzumab…