Regulation - Anti-virals, Vaccines

Filter

Current filters:

Anti-viralsVaccines

Popular Filters

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

“Overwhelming approval” in store for Heplisav if Dynavax delivers sufficient safety data, says analyst

27-02-2014

Despite citing the need for further safety studies, both US and EU regulators have lauded the immunogenicity…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavRegulationResearchVaccines

Dynavax withdraws European MAA for Heplisav

18-02-2014

US biotech firm Dynavax Technologies says it has withdrawn the European Marketing Authorization Application…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

Leading Chinese hepatitis B vaccine makers stop production; Pfizer drug import halted

03-01-2014

China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers…

Anti-viralsAntibiotics and Infectious diseasesAsia-PacificBioKangtaiChinaFluconazolePfizerPharmaceuticalRegulationVaccines

China bans BioKangtai hepatitis B vaccine

26-12-2013

Chinese authorities on Friday issued a circular to ban the use of the recombinant hepatitis B vaccine…

Anti-viralsAsia-PacificBioKangtaiChinaHealthcarePharmaceuticalRegulationVaccines

AstraZeneca’s Fluenz Tetra cleared in EU

AstraZeneca’s Fluenz Tetra cleared in EU

06-12-2013

The European Commission has granted Marketing Authorization to Fluenz Tetra, the product’s maker Anglo-Swedish…

Anti-viralsAstraZenecaEuropeFluenz TetraPharmaceuticalRegulationVaccines

US FDA approves shipment of quadrivalent flu vaccine to health care providers

06-08-2013

The US subsidiary of UK pharma giant GlaxoSmithKline (LSE: GSK) says it has received Food and Drug Administration…

Anti-viralsFluarixGlaxoSmithKlineNorth AmericaPharmaceuticalRegulationVaccines

Negative FDA news for AVEO's tivozanib and Dynavax' hep B vaccine

11-06-2013

US biotech firm AVEO Oncology (Nasdaq: AVEO) says that it has received a complete response letter from…

Anti-viralsAstellas PharmaAVEO OncologyBiotechnologyDynavax TechnologiesHeplisavNorth AmericaOncologyPharmaceuticalRegulationtivozanibVaccines

FDA delays approval of Dynavax' Heplisav, issuing CRL

26-02-2013

Dynavax Technologies ( Nasdaq: DVAX) saw its shares plunge as much as 38% to $1.84 in pre-market trading…

Anti-viralsBiotechnologyDynavax TechnologiesHeplisavNorth AmericaRegulationVaccines

FDA approves Protein Sciences egg-free flu vaccine Flublok; and Octapharma's Octaplas

18-01-2013

The US Food and Drug Administration revealed it has approved privately-held US biotech firm Protein Sciences…

Anti-viralsBiotechnologyFlublokMergers & AcquisitionsNorth AmericaOctapharmaOctaplasPanblokPharmaceuticalProtein Sciences CorpRegulationVaccines

US FDA agrees to review Sanofi Pasteur's new quadrivalent influenza vaccine

18-10-2012

Sanofi Pasteur, the vaccines division of Sanofi (Euronext: SAN) says it has filed a supplemental Biologics…

Anti-viralsNorth AmericaPharmaceuticalRegulationSanofiSanofi PasteurVaccines

EMA accepts Dynavax' filing for hep B drug Heplisav

23-08-2012

US biotech firm Dynavax Technologies (Nasdaq: DVAX) revealed yesterday that the European Medicines Agency…

Anti-viralsBiotechnologyDynavax TechnologiesEuropeHeplisavRegulationVaccines

EU Commission OKs Baxter Avian flu vaccine Vepacel; drops GSK probe

05-03-2012

US drugmaker Baxter International (NYSE:BAX) says that the European Commission has granted marketing…

Anti-viralsBaxter InternationalEuropeGlaxoSmithKlineLegalPharmaceuticalRegulationSynthonVaccinesVepacel

FDA OKs first quadrivalent flu vaccine; and lower dose Angeliq

01-03-2012

Anglo-Swedish drug major AstraZeneca (LSE: AZN) US unit MedImmune's FluMist Quadrivalent, a vaccine to…

Anti-viralsNorth AmericaPharmaceuticalRegulationVaccinesWomen's Health

Back to top