Food and Drug Administration

FDA Approves Another Interchangeable Biosimilar Drug

By Kevin E. Noonan — On October 15th, the Food and Drug Administration approved its second interchangeable biosimilar drug. That drug is Cyltezo (adalimumab-adbm), produced by Boehringer Ingelheim, which obtained biosimilar approval on August 25, 2017. In this recent approval, the FDA determined that Cyltezo is interchangeable with AbbVie’s Humira (adalimumab), its reference product. Cyltezo …

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Qué pasa si combino vacunas en la dosis de refuerzo

La FDA podría autorizar dosis de refuerzo de vacunas diferentes de los que los estadounidenses recibieron en sus primeras dosis. Hay evidencia científica prometedora que respalda la medida.

Qué pasa si combino vacunas en la dosis de refuerzo

La FDA podría autorizar dosis de refuerzo de vacunas diferentes de los que los estadounidenses recibieron en sus primeras dosis. Hay evidencia científica prometedora que respalda la medida.

Sales of Biogen’s Alzheimer’s Drug Fall Short of Expectations

The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue for the rest of the year.

Sales of Biogen’s costly new Alzheimer’s drug fall far short of expectations.

The drug, Aduhelm, brought in $300,000 in revenue in its first full three months of availability. The company expects the drug to generate minimal revenue for the rest of the year.

F.D.A. to Allow ‘Mix and Match’ Approach for Covid Booster Shots

The agency may act this week, when it is expected to authorize booster shots for recipients of the Moderna and Johnson & Johnson vaccines.

F.D.A. Vaccine Booster Panel: Here’s Who Is on the Roster

The experts’ recommendations, though not binding, are likely to influence what the Food and Drug Administration decides on whether to authorize the boosters.

Pfizer Asks F.D.A. to Authorize Its Covid-19 Vaccine for Children 5 to 11

The agency has promised to move quickly on the request and has tentatively scheduled a meeting at the end of the month to consider it.

Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot

The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.

Johnson & Johnson to Seek F.D.A. Authorization for Booster Shot

The request, expected this week, comes after a study found the company’s vaccine was only 71 percent effective against hospitalization from Covid-19.

Was the Decision on Boosters Bungled?

Readers discuss the government’s handling of the issue. Also: Abortion stories; criminal justice reform; voice recognition; extinct species.

La desinformación sobre la covid genera la escasez de ivermectina, un medicamento para animales

El mundo agropecuario lucha contra la creciente demanda de ivermectina, un medicamento antiparasitario que las redes de desinformación aseguran, sin pruebas, que ayuda contra el coronavirus.

How Covid Misinformation Created a Run on Animal Medicine

Veterinarians, ranchers and farmers say they are struggling with the effects of the surging demand for ivermectin, a deworming drug.

FDA Approves Biosimilar Drug for Treating Macular Degeneration

By Kevin E. Noonan — The U.S. Food and Drug Administration approved the first biosimilar drug for treating macular degeneration under the provisions of the Biologics Price Competition and Innovation Act (BPCIA, codified at 42 U.S.C. § 262) as part of the Affordable Care Act of 2010 (colloquially known as “Obamacare”). The drug is Byooviz …

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Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.

Study of Covid Booster Shot Benefits Fans Debate Over Extra Doses

Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.

Study of Booster Shot Benefits Fans Debate Over Extra Doses

Independent experts, including government scientists, were skeptical of the research from Israel, which included limited data over a short period.

Ohio Judge Reverses Order Requiring Covid Patient to Be Given Ivermectin

An intubated patient was prescribed the deworming drug by his doctor. Federal health officials have said that it has not been shown to be effective against the coronavirus and that it can be toxic in humans.

Ivermectin Won’t Treat Covid-19, but Demand Is High Anyway

The drug has spared hundreds of millions of Africans from serious parasites, but clinical trials have repeatedly failed to show that it is effective against Covid. Still, U.S. demand is high.

House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval

The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.

House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval

The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.

House Committees Demand F.D.A. Records on Alzheimer’s Drug Approval

The agency approved Biogen’s Aduhelm “despite concerns raised by experts,” committee leaders said in a letter.

As Virus Cases Surge, Biden Administration Encourages More Use of Antibody Treatments

A top White House adviser said monoclonal antibody treatments, sometimes underused, could still be crucial in helping people with Covid-19 avoid getting very sick.

As Virus Cases Surge, Biden Administration Encourages More Use of Antibody Treatments

A top White House adviser said monoclonal antibody treatments, sometimes underused, could still be crucial in helping people with Covid-19 avoid getting very sick.

Some Are Chasing Extra Vaccine Shots, While Scientists Debate

Boosters may not be necessary yet, many experts say, and the pursuit of additional shots raises ethical questions.

FDA Approves First Interchangeable Biological Product

By Kevin E. Noonan — Last week the U.S. Food and Drug Administration approved an interchangeable biosimilar to insulin glargine, an approval notable because it is the first approved interchangeable biosimilar product. The product is Semglee (insulin glargine-yfgn), produced by Mylan Pharmaceuticals, Inc., and under this approval, it is interchangeable with Lantus (insulin glargine) made …

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F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

F.D.A. Aims to Give Final Approval to Pfizer Vaccine by Early Next Month

The Food and Drug Administration’s move is expected to kick off more vaccination mandates for hospital workers, college students and federal troops.

U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

U.S. Authorities Seek Documents From Troubled Covid Vaccine Manufacturer

Emergent BioSolutions, which ruined 75 million vaccine doses at its Baltimore plant, disclosed records requests from Congress and federal and state law enforcement agencies.

Vaccine Makers Are Asked to Expand Safety Studies on Children

The F.D.A. wants Pfizer and Moderna to increase the number of 5- to 11-year-olds who participate in trials of their coronavirus vaccines to ensure there is enough data about rare side effects.

Johnson & Johnson podría ser menos eficaz contra la variante delta

Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.

Johnson & Johnson podría ser menos eficaz contra la variante delta

Muchos de los que recibieron la vacuna pueden necesitar refuerzos, dijeron los autores. Pero las autoridades sanitarias federales no recomiendan segundas dosis.

How Aduhelm, an Unproven Alzheimer’s Drug, Got Approved

Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.

How an Unproven Alzheimer’s Drug Got Approved

Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.

U.S. Officials Push Back on Pfizer’s Request for Booster Shot Approval

After meeting with company representatives, officials said the decision would depend partly on data on infections in vaccinated people that cause serious disease or hospitalization.

F.D.A. Attaches Warning of Rare Nerve Syndrome to Johnson & Johnson Covid Vaccine

Federal regulators concluded that the risk of developing the syndrome was low, and that the benefits of the vaccine still strongly outweigh it.

Biden Makes New Push for Vaccinations, but Experts Say More Is Needed

Some public health experts worry that the administration is not being aggressive enough in waging what the president calls a “wartime effort” to vaccinate the country.

FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.

FDA Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.

F.D.A. Set to Authorize Pfizer Vaccine for Adolescents by Early Next Week

The U.S. vaccination campaign will soon expand to millions more people, but public health experts say the move raises complicated questions about supply and access.

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

Biden to Send Coronavirus Vaccine Abroad

President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a four-alarm fire.”

‘Why Is it so Expensive?’ We Asked People From Around the World What They Think of U.S. Health Care.

We asked eight people from around the world what they thought about American health care. It didn’t go well.

Biden to Send Coronavirus Vaccine Abroad

President Biden will send up to 60 million doses of AstraZeneca’s vaccine to countries pleading for help, but some see a medicine dropper for “a four-alarm fire.”

Federal Inspectors Fear More Vaccines Exposed to Contamination

Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.

Federal Inspectors Say More Vaccines at Troubled Plant May Be Contaminated

Last month, up to 15 million doses of Johnson & Johnson’s vaccine had to be discarded at Emergent’s factory in Baltimore. A new report says problems were not fully investigated and other doses may be compromised.

Science Plays the Long Game. But People Have Mental Health Issues Now.

I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis on helping people in distress today.

Science Plays the Long Game. But People Have Mental Health Issues Now.

I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis on helping people in distress today.

Science Plays the Long Game. But People Have Mental Health Issues Now.

I’ve reported on behavior and mental health for 20 years. As I exit, I can’t help but wonder why researchers have placed so little emphasis on helping people in distress today.

Coronavirus Pandemic Forces FDA to Sharply Curtail Drug Company Inspections

The steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics say inspectors should be considered essential workers and do their jobs.

Pandemic Forces F.D.A. to Sharply Curtail Drug Company Inspections

The steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics say inspectors should be considered essential workers and do their jobs.

Biden Vows Enough Vaccine ‘for Every Adult American’ by End of May

The pharmaceutical giant Merck & Co. agreed to help manufacture Johnson & Johnson’s coronavirus vaccine, in a deal partly brokered by the White House.

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 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 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

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.