XTalks

NOVEMBER 7, 2022

Immunofluorescent staining of CTCs is a CTC isolation method that has been used since the first US Food and Drug Administration (FDA) approval in 2013 for the CellSearch ® CTC enumeration platform. Regulatory Approvals for CTC-Based Assays in Oncology. Table 1: Some examples of cfDNA-based assays that are approved by the US FDA.

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The Pharma Data

DECEMBER 8, 2020

Nasdaq: MRNA) a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced the Swiss Federal Government has increased its confirmed order commitment from 4.5 MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. million to 7.5

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The Pharma Data

JANUARY 21, 2021

In the ATLAS study, CABENUVA met the primary endpoint for noninferiority (the proportion of participants with plasma HIV-1 RNA ?50 50 copies per milliliter [c/mL] at Week 48), with a comparable number of patients receiving either CABENUVA or their daily current antiretroviral regimen (CAR) having an HIV-1 RNA level ?50

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Delveinsight

DECEMBER 13, 2020

In July 2017, the US FDA approved sofosbuvir/velpatasvir/voxilaprevir? Vosevi) to treat adult chronic hepatitis C of all genotypes previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor. in January 2019.

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The Pharma Data

DECEMBER 18, 2020

In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness, and manufacturing quality information. The Moderna COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material.

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The Pharma Data

NOVEMBER 16, 2020

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine (mRNA-1273) against the novel coronavirus, the conditions under which mRNA-1273 can be shipped, stored and administered, and the U.S.

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pharmaphorum

JANUARY 5, 2022

Oral agents will be a useful adjunct, but vaccination will remain the primary lever to contain the pandemic, with innovations in COVID-19 vaccines appearing in 2022. For example, Eli Lilly’s donanemab has a rolling FDA submission, and a 2022 phase III readout, with possible FDA approval in H2/2022. CNS’s moment of truth.

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Pharmaceutical Technology

NOVEMBER 22, 2022

326 days after SARS-CoV-2 was first sequenced, the FDA approved Pfizer and BioNTech’s Comirnaty® under Emergency Use Authorization (EUA). According to CEPI: “Achieving the 100 Days Mission would give the world a fighting chance of containing a future outbreak before it spreads to become a global pandemic.”.

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The Pharma Data

DECEMBER 10, 2020

Both vaccination regimens resulted in complete protection from subsequent viral ‘challenge’ as reflected by reductions in viral RNA levels that were below the level of detection by day seven post-challenge compared to controls. Additional safety and neutralizing data are currently being collected/analyzed.

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The Pharma Data

NOVEMBER 16, 2020

Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. CAMBRIDGE, Mass.–(BUSINESS

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XTalks

OCTOBER 26, 2023

The US Food and Drug Administration (FDA) approved new updated COVID-19 vaccines from both Pfizer-BioNTech and Moderna that target the Omicron XBB.1.5 In May, the FDA approved GSK’s Arexvy as the first RSV vaccine, which was shortly followed by the approval of Pfizer’s RSV vaccine Abrysvo.

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XTalks

AUGUST 2, 2023

Comirnaty was first approved by the US Food and Drug Administration (FDA) in August 2021 for individuals over the age of 16. It contains the antiviral medications nirmatrelvir and ritonavir. In addition, the FDA approved Pfizer’s pneumococcal 20-valent conjugate vaccine, Prevnar 20, for the first time in June 2021.

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pharmaphorum

MARCH 4, 2021

billion for its FDA-approved dry eye drug Xiidra during the Japanese pharma’s merger with Shire in 2019, outlining the sales potential in this market niche. Sylentis, part of PharmaMar Group, has just announced FDA approval of a phase 3 trial for eye drops containing tivanisiran, in dry eye disease associated with Sjogren’s Syndrome.

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Drug Discovery World

AUGUST 10, 2022

Finally, in 2017, after years of improving T cell engineering techniques, the first chimeric antigen receptor (CAR) T cell therapy received FDA approval. Since 2017, five CAR T cell therapies have been approved and have shown incredible success in the clinic. CAR T cells are T cells that have been trained to attack tumours.

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The Pharma Data

JANUARY 12, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has authorized the COVID-19 Moderna Vaccine in Switzerland. MRNA-1273 (SARS-CoV-2 vaccine) FDA Approval History. CAMBRIDGE, Mass.–(BUSINESS

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The Pharma Data

JANUARY 6, 2021

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission has granted a conditional marketing authorization (CMA) for COVID-19 Vaccine Moderna, allowing vaccination programs using the Moderna vaccine to be rolled out across the European Union. About Moderna.

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The Pharma Data

NOVEMBER 30, 2020

Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.

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The Pharma Data

MAY 13, 2021

Low Level Light therapy (LLLT), is FDA approved for treating conditions such as chronic joint pain and slow to heal wounds. (3). Stimulates DNA and RNA synthesis. It contains something called boswellic acids that gives it these amazing properties. Aloe Vera contains beneficial plant compounds that help alleviate pain.

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Pfizer

NOVEMBER 2, 2022

The first participant has been dosed in a Phase 1 trial evaluating the safety, tolerability, and immunogenicity of a nucleoside-modified RNA (modRNA)-based combination vaccine approach. receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. . COMIRNATY® (COVID-19 Vaccine, mRNA). INDICATION.

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