FDA Drugs and Biologics

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Oct 17

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Posts 14 posts

#	Date	Post	↓ Outlier	Views	Likes	Reposts	Bookmarks
1	Oct 14	Big news for bladder cancer patients! FDA just expanded approval of Anktiva with BCG for adults with BCG-unresponsive, high-grade papillary-only NMIBC — the first treatment approve	11.6×	49k	421	99	27
2	Oct 14	The FDA today launched the Rare Disease Framework Initiative to reimagine rare disease drug development. The new framework will adapt aspects of the agency’s long-standing approach	4.7×	20k	125	43	20
3	Sep 24	News: @FDA approved a new long-acting insulin taken once a week for adults with type 2 diabetes to help manage their blood sugar along with diet and exercise.	2.6×	11k	60	24	16
4	Sep 24	Today, the FDA approved a treatment for advanced renal cell carcinoma.	2.1×	8.8k	50	11	8
5	Sep 25	Today, @FDA approved an oral treatment for adults and pediatric patients aged 12 years and older with fibrodysplasia ossificans progressiva, providing an additional option for peop	1.6×	7k	42	12	6
6	Sep 28	The FDA has approved a new tablet for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also known as Allan-Herndon-Dudley syndrome — making it t	1.3×	5.7k	22	2	8
7	Oct 5	FDA is seeking public input on the design of early-stage clinical trials involving ibogaine products. We want to hear from the public on dosing, safety monitoring, patient safeguar	1.1×	4.5k	10	3	2
8	Oct 2	Today, @FDA marks the first anniversary of the prioritization program for the review of abbreviated new drug applications (ANDAs) that meet specific domestic testing and manufactur	0.9×	4k	8	0	2
9	Oct 7	News: Today, the @FDA approved a maintenance treatment for adults with unresectable locally advanced or metastatic HER2-positive breast cancer.	0.9×	4k	14	7	2
10	Sep 24	One size does not fit all in cancer treatment. Watch this FDA Office of Women’s Health webinar to learn about high-grade serous #OvarianCancer, early diagnosis challenges, and curr	0.9×	3.9k	8	1	1
11	Oct 14	Two days until the "Patient Voice in Rare Disease Medical Product Development" Public Meeting! There's still time to register! ⤵️	0.9×	3.8k	13	3	1
12	Oct 14	FDA’s #PrescribeWithConfidence campaign supports the Trump Administration’s Great American Recovery Initiative by helping expand access to evidence-based treatment for #OpioidUseDi	0.9×	3.7k	4	1	0
13	Sep 24	📢 Join us October 26 for a public meeting on #BsUFA reauthorization: Share your input on proposed recommendations for the fourth reauthorization of the Biosimilar User Fee Amendme	0.6×	2.4k	8	1	2
14	Oct 16	FDA has approved apraclonidine ophthalmic solution, 0.125%, for adults and children over 12 for relief of eye redness, giving consumers an additional safe and effective #nonprescri	0.5×	1.9k	9	2	1
15	Sep 28	MCT8 deficiency is a rare genetic disorder that primarily affects males. It is caused by a faulty gene responsible for making the MCT8 transporter — a critical protein that carries	0.3×	1.2k	3	0	1
16	Sep 28	This approval reflects the FDA's deep commitment to patients with rare conditions who need meaningful treatment options.	0.2×	865	3	0	0

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