Delilah Alvarado

Texas

Writer for @Biopharmadive. Girl with the dragon tattoo. Chicana. Words in @Prismreports, @wearemitu, @YRMedia, @BuiltIn. https://t.co/H1FtFYMFA7

Articles

Rallybio discontinues lead drug for rare maternal disorder

2 weeks ago | biopharmadive.com | Delilah Alvarado

Dive Brief:The biotechnology company Rallybio is discontinuing its lead candidate for a rare blood disorder in pregnant women after disappointing data from a mid-stage study, sending shares down sharply Tuesday morning.
FDA misses approval deadline for Novavax’s COVID-19 vaccine

3 weeks ago | biopharmadive.com | Delilah Alvarado

The Food and Drug Administration review deadline for Novavax’s COVID-19 vaccine has come and gone without a decision amid a major organizational shakeup that has already resulted in the resignation of the nation’s top vaccine regulator. Novavax’s shot in 2022 was granted an emergency use authorization, a special approval handed out during a public health emergency.
FDA official’s ouster sends shares of vaccine makers sliding

3 weeks ago | biopharmadive.com | Delilah Alvarado

Shares of several prominent vaccine makers fell Monday morning after the resignation late Friday evening of the Food and Drug Administration’s top vaccine official, Peter Marks. In his resignation letter, Marks cited differences with new Health and Human Services Secretary Robert F.
HHS announces sweeping reorganization, including cuts of 10K workers

4 weeks ago | healthcaredive.com | Rebecca Pifer |Delilah Alvarado

Listen to the article 4 minThe HHS on Thursday announced a sweeping reorganization that includes firing 10,000 full-time employees, in a significant downsizing for a department that responds to disease outbreaks, provides health insurance to 160 million Americans, ensures the safety of drugs and medical devices and more.
FDA approves first-of-its-kind antibiotic from GSK

4 weeks ago | biopharmadive.com | Delilah Alvarado

Dive Brief:The Food and Drug Administration on Tuesday cleared a new kind of oral antibiotic for the treatment of common urinary tract infection in women and girls 12 years or older. The oral drug gepotidacin, which its maker GSK will sell as Blujepa, is approved to treat uncomplicated urinary tract infections caused by five common types of bacteria, including E. coli. More antibiotic options are needed as the threat of microbial resistance to drugs grows.
FDA approves first-of-its-kind antibiotic from GSK

4 weeks ago | yahoo.com | Delilah Alvarado

Delilah AlvaradoWed, March 26, 2025 at 12:00 PM UTC2 min readA GSK logo is seen on the side of an office building in Poznan, Poland. This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Dive Brief:The Food and Drug Administration on Tuesday cleared a new kind of oral antibiotic for the treatment of common urinary tract infection in women and girls 12 years or older.
Tempero Bio gets $70M to advance substance abuse treatment

1 month ago | biopharmadive.com | Delilah Alvarado

Tempero Bio, a biotechnology company based in Oakland, California, has secured $70 million to advance a drug it’s developing into mid-stage testing for cocaine and alcohol use disorders. The Series B round, announced by Tempero Monday, will support two Phase 2 trials of the drug, called TMP-301. The biotech will also use the funds to prepare for late-stage studies as well as to explore additional indications and formulations.
Delayed CDC meeting on vaccines is rescheduled to April

1 month ago | biopharmadive.com | Delilah Alvarado

A postponed meeting of vaccine advisers to the Centers for Disease Control and Prevention is now scheduled to take place in April, a spokesperson for the Department of Health and Human Services confirmed. The Advisory Committee on Immunization Practices, or ACIP, had originally been scheduled to meet Feb. 26 to Feb. 28, but was unexpectedly delayed soon after Robert F. Kennedy Jr., a longtime critic of U.S. vaccination policies, took office as health secretary.
Taiho buys Swiss biotech and its ADC tech for $400M

1 month ago | biopharmadive.com | Delilah Alvarado

Japan-based Taiho Pharmaceuticals on Monday said it will acquire Switzerland’s Araris Biotech and its antibody-drug conjugate technology for $400 million upfront. The two companies have worked together since 2023, when they agreed to use Araris’ technology to explore and develop new drug candidates aimed at targets chosen by Taiho. The deal announced Monday, which they expect to close in the first half of this year, could hand Araris up to $740 million more if certain milestones are met.
FDA sets flu shot recommendations without input of outside advisers

1 month ago | biopharmadive.com | Delilah Alvarado

The Food and Drug Administration on Thursday recommended to influenza vaccine manufacturers which virus strains to include in next season’s shots. Typically, the agency sets its advice after consulting a committee of outside advisers, a meeting of whom had been scheduled to take place in March. But that meeting was abruptly canceled last month without explanation.