Moderna’s Simple Fix to Vaccine Supply: More Doses in Each Vial

The company will ask federal regulators to increase the amount of coronavirus vaccine it can put in each vial by as much as 50 percent, potentially bolstering availability quickly.

Biden Pledges to Speed Flow of Vaccines to the States

President Biden said the number of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

Biden Pledges to Speed Flow of Vaccines to the States

President Biden said the amount of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

Biden Pledges to Speed Flow of Vaccines to the States

President Biden said the number of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

Biden Pledges to Speed Flow of Vaccines to the States

President Biden said the number of coronavirus vaccines reaching the states would rise next week and a deal was near to provide enough shots to vaccinate nearly all Americans by the end of summer.

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.

Biden Picks Former F.D.A. Chief Kessler to Lead U.S. Vaccine Efforts

Dr. David Kessler, who helped speed the development and approval of AIDS drugs in the 1990s, will become the top science official for the initiative the Trump administration had called Operation Warp Speed.

FDA gives nod to Moderna vaccine for Covid-19

The company’s vaccine is the second approved for emergency use by the FDA. It is expected to pose fewer logistical challenges than the first, which was developed by Pfizer and BioNTech.

F.D.A. Clears Moderna’s Covid Vaccine

The Food and Drug Administration authorized a second coronavirus vaccine for emergency use, clearing the way for millions more Americans to be immunized next week.

Vacuna de Moderna contra el coronavirus: lo que necesitas saber

La revisión positiva probablemente asegure que la Administración de Alimentos y Medicamentos (FDA, por su sigla en inglés) concederá esta semana la autorización de emergencia para una segunda vacuna contra el coronavirus para millones de estadounidenses.

Vacuna de Moderna contra el coronavirus: lo que necesitas saber

La revisión positiva probablemente asegure que la Administración de Alimentos y Medicamentos (FDA, por su sigla en inglés) concederá esta semana la autorización de emergencia para una segunda vacuna contra el coronavirus para millones de estadounidenses.

U.S. and Pfizer Are Negotiating Deal for More Vaccine Doses Next Year

The Trump administration is discussing helping the drug maker get the raw materials it would need to produce tens of millions of extra doses of its Covid-19 vaccine in the spring.

La vacuna de Moderna tiene altos índices de protección contra el coronavirus. ¿Cómo es distinta de la vacuna de Pfizer-BioNTech?

La revisión positiva probablemente asegure que la Administración de Alimentos y Medicamentos (FDA, por su sigla en inglés) concederá esta semana la autorización de emergencia para una segunda vacuna contra el coronavirus para millones de estadounidenses.

Pfizer’s Covid Vaccine and Allergies: How Concerned Should You Be?

British health officials recommended that people with severe allergy reactions not be given the vaccine. Such reactions to vaccines are rare, even in people who have allergies to food or bee stings.

A New Way to Ease the Worry That You May Be Pregnant

Marketed as “missed-period pills,” abortion drugs administered as early as 28 days after a woman’s last period can offer comfort in uncertainty to those who want it.

Berry-Flavored H.I.V. Medication Is Ready for Babies

For the 80,000 children who die of H.I.V. each year, drugs are often bitter or hard to swallow. Dolutegravir will soon come in a tasty dissolving tablet.

McKinsey Proposed Paying Pharmacy Companies Rebates for OxyContin Overdoses

Court filings reveal consultants’ talk of a records purge during the opioid crisis, and shed new light on sales advice given to the billionaire Sackler family and their drug company, Purdue Pharma.

Pfizer Applies for Emergency F.D.A. Approval for Covid-19 Vaccine

A large team of regulators at the agency will take about three weeks to review an application spanning thousands of pages.

With 90% efficacy against Covid-19, Pfizer/BioNTech’s vaccine jumps ahead in global race

Finish line ahead

The news sent the stock market soaring as it represents a key milestone in developing and distributing a vaccine for the virus. Still public confidence in vaccines need to be boosted, an expert noted.

FDA issues Covid-19 vaccine guidance as White House reportedly relents

The guidance calls for a median two months’ worth of follow-up safety data from well-designed Phase III studies as a precondition for a vaccine receiving an EUA. The Wall Street Journal reported that the White House had backed down in its opposition to the guidance, which pushes the date of an EUA past Election Day.

Report: FDA takes closer look at adverse event that occurred in AstraZeneca Covid-19 vaccine study

Reuters reported Wednesday that U.S. regulators would look at data from previous clinical trials that came from the same scientists who created the vaccine, AZD1222, which originated at the University of Oxford and is also known as ChAdOx1 nCoV-19.

Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend

The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.

FDA’s emergency authorization for convalescent plasma in Covid-19 sparks controversy

While the emergency use authorization granted Sunday was not seen as scientifically unwarranted, it drew concerns from some experts that it could hinder enrollment in clinical trials, while the timing and circumstances of the FDA’s move fueled suspicions that political pressure – rather than science and data alone – may have played a role.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

Report: FDA halted move to authorize convalescent plasma for Covid-19 over evidence concerns

The New York Times reported that the FDA was prepared to issue an emergency use authorization for the treatment last week, but NIH Director Francis Collins and NIAID Director Anthony Fauci intervened, arguing that data were too weak.

FDA rejects BioMarin’s hemophilia A gene therapy in ‘massive surprise’

In a CRL issued for valoctocogene roxaparvovec, the FDA told BioMarin that differences between its Phase I/II and Phase III studies limited the ability to rely on the earlier trial to support durability of effect, which an analyst said likely referred to a product comparability issue.

FDA issues surprise rejection of Gilead, Galapagos rheumatoid arthritis drug

While there had been some risks to filgotinib’s approval cited before, analysts expressed surprise at the decision, with one writing it would likely delay approval by at least a year. Shares of both companies fell sharply on the news.

Platform study designed to rapidly screen potential Covid-19 drugs enrolls first patients

Three of the companies making drugs used in the Phase II I-SPY COVID-19 study – Amgen, AbbVie and Takeda – announced the patient enrollments Monday. The study, which will enroll up to 1,500 critically ill patients, could test around 10 drugs.

FDA guidance eases some Covid-19 vaccine concerns, but others remain

Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.