FDA Drugs and Biologics

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[FDA Drugs and Biologics @FDADrugs]

Our X handle is changing! Starting Aug. 7th, @FDA_Drug_Info becomes @FDADrugs. Your follow carries over automatically with no action needed on your end. Same reliable drug safety and approval information, new name.

[FDA Drugs and Biologics @FDADrugs]

Heads up! Tomorrow @FDA_Drug_Info officially becomes @FDADrugs on X. No action needed on your end. Your follow transfers over automatically.

[FDA Drugs and Biologics @FDADrugs]

NEWS: @US_FDA approves a treatment for prostate cancer. https://t.co/Dhdufznjes

[FDA Drugs and Biologics @FDADrugs]

CORRECTION: The docket will be open for 6 months.

[FDA Drugs and Biologics @FDADrugs]

🦷FDA is seeking data on a non-animal lab test that could modernize the methods used to uphold effectiveness standards of cavity-prevention toothpastes.

Docket open for 18 months.
🔗https://t.co/rQTKrrZ3fT
#OTCMonograph #AnimalAlternatives

[FDA Drugs and Biologics @FDADrugs]

CORRECTION: The docket will be open for 6 months.

[FDA Drugs and Biologics @FDADrugs]

🦷FDA is seeking data on a non-animal lab test that could modernize the methods used to uphold effectiveness standards of cavity-prevention toothpastes.

Docket open for 18 months.
🔗https://t.co/rQTKrrZ3fT
#OTCMonograph #AnimalAlternatives

[U.S. FDA @FDA]

Today, FDA published a batch of revised draft product-specific guidances (PSGs) for certain generic peptide drug products, helping facilitate the timely development of high-quality generic drugs by bringing greater efficiency and transparency to the process.

[FDA Drugs and Biologics @FDADrugs]

NEWS: @US_FDA approves a treatment for ROS1-positive non-small cell lung cancer.
https://t.co/yaGzleI3z3

[FDA Drugs and Biologics @FDADrugs]

Lasting up to 12 hours, this approval gives consumers another OTC option for temporary relief of minor aches and pains, including headache, backache, muscle aches, toothache, menstrual cramps & minor arthritis pain.

Read the full notable approval → https://t.co/h3k9kpWsSp

[FDA Drugs and Biologics @FDADrugs]

FDA approved Tylenol with Naproxen (acetaminophen 325 mg/naproxen sodium 110 mg) — the first fixed-dose combination of these two well-known pain relievers in a single tablet.

[FDA Drugs and Biologics @FDADrugs]

Explore sameness demonstration, recombinant peptide production, oral formulation BE strategies, and drug-device assessment considerations.

[FDA Drugs and Biologics @FDADrugs]

Registration is OPEN! Don't miss the FDA-CRCG hybrid workshop on Navigating the #GLP1 Generic Drug Pathway (Sept 23-24).

Secure your spot: https://t.co/yek1T1I2vv

[U.S. FDA @FDA]

This #UVSafetyMonth, protect your whole family — including the littlest ones! But when it comes to babies, should you reach for the sunscreen? The answer might surprise you! Watch this video for expert advice on keeping your baby safe in the sun. ➡️ https://t.co/zcAcHPpMLN

[U.S. FDA @FDA]

FDA has approved the first oral PCSK9 inhibitor to reduce LDL ("bad") cholesterol in adults with high cholesterol. Until now, PCSK9 inhibitors were only available as injections. The once-daily tablet provides an additional treatment option for adults who need further LDL-C reduction despite existing therapies.

[FDA Drugs and Biologics @FDADrugs]

For more information and to register, visit: https://t.co/MjBiUEPK8t

[FDA Drugs and Biologics @FDADrugs]

On September 1, 2026, the FDA Quantitative Medicine Center of Excellence, in collaboration with @DukeMargolis will host the “Innovation in Quantitative Medicine Summit” virtual public meeting.

[U.S. FDA @FDA]

☀️ It's #UVSafetyMonth — and we're busting sunscreen myths! Think sunscreen is waterproof? Think again! Sunscreen may be water resistant, but no sunscreen is truly waterproof. When swimming or sweating, reapply at least every two hours to stay protected.

All sunscreens must provide directions on when to reapply, so check that label! Stay sun-smart this July and learn the facts: https://t.co/1a858WMzgx

[FDA Drugs and Biologics @FDADrugs]

Learn more: https://t.co/gUlrb8Lk1Q

[FDA Drugs and Biologics @FDADrugs]

Today, FDA approved the first generic version of GILOTRIF – a milestone in expanding patient access to an important oncology treatment for metastatic non-small cell lung #cancer (NSCLC).
#lungcancer

[FDA Drugs and Biologics @FDADrugs]

NEWS: @US_FDA approves a treatment for HR-positive, HER2-nevative breast cancer.
https://t.co/lFp3L1reDe