FDA Drugs and Biologics

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[FDA Drugs and Biologics @FDADrugs]

Today, we approved a treatment for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer. This approval gives some people with advanced breast cancer whose tumors have a specific genetic mutation another treatment option. https://t.co/BCyaEILpy5

[FDA Drugs and Biologics @FDADrugs]

Today, the @US_FDA approved the first treatment for ataxia-telangiectasia (A-T) in adults and pediatric patients weighing at least 15 kg, reflecting an important milestone for families facing this progressive condition and our continued commitment to patients with rare diseases. https://t.co/kXVZwuP7zK

[FDA Drugs and Biologics @FDADrugs]

Today, we approved a one-time gene therapy for pediatric patients with Sanfilippo syndrome type A (MPS IIIA), a rare, inherited disorder that progressively damages the brain and central nervous system. This is the first approved treatment for this condition. https://t.co/en0AExxPsr

[FDA Drugs and Biologics @FDADrugs]

Today we published a final guidance for industry titled, Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method. The guidance provides recommendations on the development of blood collection, processing, and storage systems (e.g., blood bags with anticoagulant and additive solutions, empty bags for platelet pooling) intended for them anufacture of blood and blood components for transfusion using the buffy coat method and on regulatory submissions to FDA for such products. https://t.co/0kzAQdPh5d

[FDA Drugs and Biologics @FDADrugs]

Today we announced the final design of the Expedited Investigational New Drug (IND) Pilot, a key Trump Administration priority to accelerate American medical innovation and keep early clinical research in the U.S. The program seeks to accelerate the time from a drug being identified to a first-in-human clinical trial. FDA will be partnering drug companies with qualified research institutions that have scientific and regulatory expertise to support efficient IND applications. The agency will accept applications to participate in the pilot until October 30, 2026. https://t.co/iLxwt3wFGI

[FDA Drugs and Biologics @FDADrugs]

Today we approved Isembyld, the first therapy to directly target muscle weakness linked to muscle loss in patients with the rare disease of spinal muscular atrophy (SMA). Designed to work alongside existing SMA treatments, it helps patients age 2 and older improve their strength and function.

This is a meaningful milestone for people living with spinal muscular atrophy, and another step forward in FDA’s commitment to advancing treatments for people with rare diseases. https://t.co/h6ehqzC6Gd

[FDA Drugs and Biologics @FDADrugs]

Today, we granted accelerated approval to a treatment for locally advanced or metastatic non-squamous non-small cell lung cancer. https://t.co/JXhJ82mRnj

[FDA Drugs and Biologics @FDADrugs]

Understanding your treatment options starts with reliable information.
#Biosimilars are FDA-approved medicines used to treat many chronic conditions, including arthritis, cancer, and kidney disease. Learn more:
https://t.co/7g89kkDZ1E

#HealthyAgingMonth

[FDA Drugs and Biologics @FDADrugs]

💡 Caring for patients with #RheumaticDisease? Learn how #biosimilars can fit into treatment conversations. Explore FDA’s Overview for Health Care Professionals for key information on biosimilars and their use: https://t.co/eAVHJnj4JD

[FDA Drugs and Biologics @FDADrugs]

CDER's Accelerating Rare disease Cures (ARC) Program released its 2025–2030 Strategic Plan, a 5-year roadmap to speed treatments for ≈30M Americans with a rare disease. Plan outlines ARC's vision, mission & strategic goals, & emphasizes cross-cutting collaboration. https://t.co/dsO3Zyty4i

[FDA Drugs and Biologics @FDADrugs]

We've issued guidance describing our temporary regulatory and enforcement priorities to help hospitals maintain access to these products while longer-term solutions are identified.

[FDA Drugs and Biologics @FDADrugs]

FDA is taking steps to help address a potential supply gap of #neonatal starter parenteral nutrition — products that provide critical IV nutrients to premature and critically ill newborns who cannot get nutrition by mouth or through a feeding tube. https://t.co/ZqIbqvavIE

[FDA Drugs and Biologics @FDADrugs]

Today, as part of the Trump Administration’s ongoing commitment to accelerating lifesaving medical innovations for American patients, we granted accelerated approval to an estrogen receptor antagonist in combination with a CDK4/6 inhibitor for adults with HR+/HER2- locally advanced or metastatic breast cancer with an ESR1 mutation. This expands treatment options for women with advanced breast cancer.

https://t.co/mXFejoR0Af

[FDA Drugs and Biologics @FDADrugs]

Today, we approved an injection for the treatment of Alexander disease in pediatric and adult patients. This is the first FDA-approved treatment for Alexander disease and the first therapy to directly target the protein buildup that drives the disease. https://t.co/VvQFRzjy6M

[FDA Drugs and Biologics @FDADrugs]

Learn more: https://t.co/zf41ePnNvH

[FDA Drugs and Biologics @FDADrugs]

Today, the @FDA issued an Emergency Use Authorization for Capstar (Nitenpyram) tablets and has revised the authorization for generic Nitenpyram tablets.

Both products are authorized for the prevention and treatment of New World screwworm infestations in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old.

Most U.S. pets remain at low risk.

[FDA Drugs and Biologics @FDADrugs]

Learn more: https://t.co/H608zYaPMB

[FDA Drugs and Biologics @FDADrugs]

The @FDA is actively working with all six manufacturers of estradiol transdermal patches to increase supply amid growing demand.

While patches remain available, availability may vary by product, pharmacy or location.

If you���re affected, please reach out to your pharmacist or healthcare provider to discuss available options.

For your safety, do not stop or change your medication without medical guidance.

[FDA Drugs and Biologics @FDADrugs]

We want to hear from researchers, clinicians, industry and other stakeholders about scientific and development challenges, innovative approaches and potential solutions. Comments are open for 60 days.

[FDA Drugs and Biologics @FDADrugs]

As part of the Trump administration’s initiative to foster innovation, FDA is seeking public input on ways to advance development of botanical drug products. https://t.co/taErvOX6ls