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Alembic receives FDA nod for AstraZeneca clotbuster generic
02 May 2025 14:46 GMT
New Delhi: Alembic Pharmaceuticals, Abbreviated New Drug Application (ANDA) for a cardiology blockbuster generic … US Food & Drug Administration (FDA).
The approved drug Ticagrelor is … to submit a substantially complete ANDA with a paragraph IV …
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FDA Filing Fee Waiver for New Drug Application of NRX-100 for Suicidal Depression
01 May 2025 16:54 GMT
… NRX’s New Drug Application for NRX-100. The NDA filing is … 100 (preservative free ketamine) New Drug Application to Treat Patients with … of U.S. New Drug Application to the FDA for NRX-100 ( … -section-of-us-new-drug-application-to-the-fda-for-nrx-100- …
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FDA Approves Satsuma’s STS101 Nasal Powder for Acute Migraine
01 May 2025 23:56 GMT
The FDA has approved Satsuma … information for our planned NDA submission. Additionally, the … Satsuma Pharmaceuticals Announces U.S. FDA Approval for Atzumi™ (Dihydroergotamine) … satsuma-pharmaceuticals-announces-us-fda-approval-for-atzumi-dihydroergotamine- …
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FDA Sends CRL for PET Imaging Agent in Progressive/Recurrent Glioma
01 May 2025 22:38 GMT
… highlighted that the FDA could not approve the new drug application (NDA) for TLX101-CDx … Limited. April 28, 2025.
FDA accepts new drug application and grants priority review for … ytm76yaa
TLX101-CDx (Pixclara™) granted FDA fast track designation. News release …
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Corneal Pain Therapy Given FDA Fast Track Designation
01 May 2025 22:38 GMT
… Limited announced that the FDA has granted Fast Track … Track designation by the FDA is granted to facilitate … Rolling Review of the New Drug Application (NDA).
Neuropathic corneal pain is … working closely with the FDA to bring this promising …
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FDA Approves Nasal Powder to Treat Migraines
01 May 2025 22:38 GMT
… that the FDA has approved a 505(b)(2) New Drug Application (NDA) for Atzumi …
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Everest Medicines Announces New Drug Application Approval Of VELSIPITY® For Adults With Moderately To Severely Active Ulcerative Colitis In Hong Kong
30 Apr 2025 09:30 GMT
… , China, has officially approved the New Drug Application (NDA) for VELSIPITY® (etrasimod) for …
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Aldeyra Therapeutics, Inc. (ALDX) Faces Scrutiny After Stock Drops 70% On FDA’s Reproxalap Complete Response Letter – Hagens Berman
01 May 2025 20:18 GMT
… CRL”) from the FDA for the resubmission of the New Drug Application (“NDA”) of reproxalap … the prospects for FDA approval of the NDA of reproxalap. In … :
“the FDA stated in the letter that the NDA ‘failed to … trial submitted to the NDA that may have affected …
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Biomednewsbreaks - Nrx Pharmaceuticals, Inc. (NASDAQ: NRXP) Granted FDA Waiver For $4.3 Million NDA Filing Fee For NRX-100
01 May 2025 18:55 GMT
… .3 million New Drug Application filing fee waiver from the FDA for NRX-100 … , enables NRx to complete its NDA by the end of Q2 … . NRx plans to file an NDA for Accelerated Approval for NRX …
NRx has recently initiated a New Drug Application filing for NRX-100 (IV …
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FDA Issues CRL to TLX101-CDx for Glioma Imaging
01 May 2025 18:19 GMT
The FDA has issued a complete response letter (CRL) to the new drug application (NDA) … .1
After reviewing the NDA, the FDA informed Telix Pharmaceuticals—the … e40a4bf3-7398-4dbd-82eb-feb10e9295fc
FDA accepts new drug application and grants priority review …
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