BioCryst’s RAPIVAB(TM) (peramivir injection) received FDA approval for treatment of influenza in adults
On Dec. 22, 2014, BioCryst Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) had approved RAPIVAB (peramivir…
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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…
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FDA approved quadrivalent formulation of Fluzone Intradermal inactivated influenza vaccine
On Dec. 12, 2014, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had approved the supplemental…
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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)…
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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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Biotechnology | Disease | FDA | NIH | Non-Profit Research | Pharmaceutical | Vaccine
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)…
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Biotechnology | Chemistry | FDA | Oncology | Therapeutics | Women's Health
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)…
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Biotechnology | Disease | FDA | Therapeutics
Omeros received FDA Approval of Omidria
On Jun. 2, 2014, Omeros received U.S. Food and Drug Administration (FDA) approval of Omidria for use in…
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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…
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Biotechnology | FDA | Oncology | Therapeutics
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…
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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…
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Biotechnology | FDA | Vaccine
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…
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FDA approved Fluzone as the third quadrivalent influenza vaccine licensed for US use
On Jun. 10, 2013, Sanofi Pasteur announced the U.S. Food and Drug Administration (FDA) had approved the supplemental…
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Biotechnology | Diagnostics | Disease | FDA | Oncology | Therapeutics
Genentech drug Kadcyla (ado-trastuzumab emtansine) was approved
On Feb. 22, 2013, the U.S. Food and Drug Administration (FDA) announced they had licensed ado-trastuzumab emtansine (Kadcyla)…
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FDA approved use of Prevnar 13 vaccine in older children and teens (6-17 years)
On Jan. 25, 2013, Pfizer announced the FDA had granted approval for the expansion of the companyﾒs pneumococcal…
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Biotechnology | FDA | Influenza | Vaccine
FDA approved quadrivalent formulation of Fluarix
On Dec. 14, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved GlaxoSmithKline’s quadrivalent formulation…
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Biotechnology | FDA | Influenza | Vaccine
FDA approved first seasonal influenza vaccine manufactured using cell culture technology
On Nov. 20, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved first seasonal influenza…
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Lucentis approved for treatment of diabetic macular edema
On Aug. 10. 2012, Genentech announced that Lucentis (ranibizumab injection) was approved by the U.S. Food and Drug…
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The FDA’s “Breakthrough Therapy Designation” was created
On Jul. 9, 2012, the FDA created the “Breakthrough Therapy Designation” that expedites development and review of drugs…
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Biotechnology | Disease | FDA | Vaccine
FDA approved HibMenCY vaccine for infants
On Jun. 24, 2012, the U.S. Food and Drug Administration (FDA) announced it had approved HibMenCY (Menhibrix, GlaxoSmithKline),…
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Biotechnology | Disease | FDA | Oncology | Therapeutics | Women's Health
Genentech drug Perjeta (pertuzumab) was approved
On Jun. 8, 2012, the U.S. Food and Drug Administration (FDA) announced that Genentech’s drug Perjeta (pertuzumab) was…
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FDA expanded licensure of PCV13 to include adults ages 50 years and older
On Jun. 7, 2012, the FDA expanded licensure of PCV13 for prevention of pneumococcal disease to include adults…
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Biotechnology | Disease | FDA | Therapeutics
FDA approved orphan drug Elelyso to treat a form of Gaucher disease
On May 1, 2012, Pfizer and Protalix BioTherapeutics announced that the U.S. Food and Drug Administration (FDA) had approved…
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Biotechnology | FDA | Infectious Disease | NIH | Vaccine
Washington State Secretary of Health declared a pertussis epidemic, Worst Since 1942
On Apr. 3, 2012, the Washington State Secretary of Health declared a pertussis epidemic. U.S. Since mid-2011, a…
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Biotechnology | Disease | FDA | Therapeutics
The FDA approved Korlym for patients with endogenous Cushing’s syndrome
On Feb. 17, 2012, the FDA announced Korlym (mifepristone) was approved to control high blood sugar levels (hyperglycemia)…
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The FDA approved KALYDECO (ivacaftor) to treat the genetic mechanism of cystic fibrosis
On Jan. 31, 2012, Vertex Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) had approved KALYDECOTM…
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Biotechnology | FDA | Oncology | Therapeutics
The U.S. FDA approved Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma
On Jan. 30, 2012, the U.S. Food and Drug Administration (FDA) approved Genentech’s Erivedge (vismodegib) capsule, the first…
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Biotechnology | FDA | Influenza | Vaccine
FDA expanded use of Prevnar 13 vaccine to include people ages 50 and older
On Dec. 30, 2011, Pfizer announced that the U.S. Food and Drug Administration (FDA) had granted approval of…
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Addition of history of intussusception as a contraindication for rotavirus vaccination
On Oct. 21, 2011, the Food and Drug Administration (FDA) announced it had approved revised prescribing information and…
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Disease | FDA | Oncology | Therapeutics
The FDA approved Seattle Genetics’ Adcetris (brentuximab vedotin)
On Aug. 19, 2011, the U.S. Food and Drug Administration (FDA) approved Seattle Genetics’ Adcetris (brentuximab vedotin), making…
