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Pfizer’s RSV vaccine wins FDA approval in older adults

Bio Pharma Dive

The shot’s clearance comes several weeks after the regulator made GSK’s Arexvy the first vaccine for RSV in the U.S.

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Takeda withdraws FDA approval application for dengue vaccine

Bio Pharma Dive

While the shot is approved in the EU, Takeda wasn’t able to address data collection issues raised by the US regulator in its current review cycle.

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5 FDA approval decisions to watch in the fourth quarter

Bio Pharma Dive

Regulators face key decisions on COVID-19 shots for children and boosters for Moderna's and J&J's vaccines. Other closely watched drugs for multiple myeloma and depression are under review, too.

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Novartis’ Fabhalta Gets FDA Approval for Rare Complement Blood Disorder

XTalks

After receiving US Food and Drug Administration (FDA) approval for Fabhalta (iptacopan) last week for the treatment of the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH), Novartis presented trial data yesterday showing the drug’s promise in another indication.

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Zydus gets FDA approval for antibiotic drug azithromycin

Pharmaceutical Technology

In August 2021, Zydus secured emergency use authorisation (EUA) from the Drugs Controller General of India for its Covid-19 deoxyribonucleic acid (DNA) plasmid vaccine, ZyCoV-D. The vaccine, which generates the SARS-CoV-2 viral spike protein on administration, induces the immune system’s cellular and humoral arm-mediated immune response.

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Pfizer, BioNTech file for FDA approval of COVID booster shot

pharmaphorum

Pfizer and BioNTech have formally asked for FDA approval of a third dose of their COVID-19 vaccine BNT162b2 in people aged over 16, as the US prepares to get its booster campaign underway. The post Pfizer, BioNTech file for FDA approval of COVID booster shot appeared first on.

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Arexvy Becomes World’s First RSV Vaccine

XTalks

This week, the US Food and Drug Administration (FDA) approved the world’s first respiratory syncytial virus (RSV) vaccine. The shot, named Arexvy, is approved for adults aged 60 years and older and was developed by GlaxoSmithKline (GSK). Who Should Get the RSV Vaccine Arexvy?