Food and Drug Administration (FDA) Clinical Trials This is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

Pharmacokinetics in Oral and Intranasal Formulations of Zolmitriptan.
Conditions: Healthy Interventions: Drug: Zolmitriptan intranasal.; Drug: Zolmitriptan oral. Sponsors: Parc de Salut Mar; Food and Drug Administration (FDA) Completed (Source: ClinicalTrials.gov)
Source: ClinicalTrials.gov - October 9, 2023 Category: Research Source Type: clinical trials

Innate Pharma Provides Update on Lacutamab Clinical Program
Innate Pharma SA October 5, 2023 -- (Euronext Paris: IPH; Nasdaq: IPHA) (“Innate” or the“Company”) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the lacutamab... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 5, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Takes Steps to Advance the Development of Novel Therapies for Stimulant Use Disorders
October 04, 2023 -- Today, the U.S. Food and Drug Administration published a new draft guidance to assist sponsors in developing treatments for stimulant use disorders. The guidance, Stimulant Use Disorders: Developing Drugs for Treatment, when... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 4, 2023 Category: Pharmaceuticals Source Type: clinical trials

U.S. Food and Drug Administration Issues Complete Response Letter for Lebrikizumab Based on Inspection Findings at Third-Party Manufacturer
INDIANAPOLIS, Oct. 2, 2023 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the lebrikizumab biologic license application (BLA) for the treatment... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 2, 2023 Category: Pharmaceuticals Source Type: clinical trials

Takeda Provides Update on Voluntary Withdrawal Exkivity ® (mobocertinib)
OSAKA, Japan and CAMBRIDGE, Massachusetts, October 2, 2023– Takeda (TSE:4502/NYSE:TAK) today announced that, following discussions with the U.S. Food and Drug Administration (FDA), it will be working with the FDA towards a voluntary... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - October 2, 2023 Category: Pharmaceuticals Source Type: clinical trials

BrainStorm Cell Therapeutics Provides Update on FDA Advisory Committee Meeting to Review NurOwn for the Treatment of ALS
NEW YORK, Sept. 27, 2023 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced the outcome of the U.S. Food and Drug Administration ' s... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 27, 2023 Category: Pharmaceuticals Source Type: clinical trials

Puma Biotechnology Receives FDA Orphan Drug Designation for Alisertib for the Treatment of Small Cell Lung Cancer
LOS ANGELES--(BUSINESS WIRE) September 21, 2023 -- Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to alisertib, a selective,... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 21, 2023 Category: Pharmaceuticals Source Type: clinical trials

U.S. Food and Drug Administration Approves Orphan Drug Designation for Immix Biopharma NXC-201 as a Treatment for Amyloid Light Chain (AL) Amyloidosis
LOS ANGELES, Sept. 21, 2023— Immix Biopharma, Inc. (Nasdaq: IMMX) (“ImmixBio” or the“Company”), a clinical-stage biopharmaceutical company pioneering personalized therapies for oncology and immunology, announced today... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 21, 2023 Category: Pharmaceuticals Source Type: clinical trials

23andMe Granted New FDA Clearance to Report Additional BRCA Variants
SOUTH SAN FRANCISCO, Calif., September 1, 2023. 23andMe Holding Co. (23andMe), a leading human genetics and biopharmaceutical company, today announced the Company has received a U.S. Food and Drug Administration (FDA) 510(k) clearance to... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - September 1, 2023 Category: Pharmaceuticals Source Type: clinical trials

U.S. Food and Drug Administration Approves Orphan Drug Designation for NXC-201 as a Treatment for Multiple Myeloma
FDA Orphan Drug Designation (“ODD”) qualifies NXC-201 for: 7 years of U.S. market exclusivity after approval Tax credits for qualified clinical testing Waiver of the Prescription Drug User Fee (currently at almost $3 million for a... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 23, 2023 Category: Pharmaceuticals Source Type: clinical trials

Gilead Announces Partial Clinical Hold for Magrolimab Studies in AML
FOSTER CITY, Calif.--(BUSINESS WIRE) August 21, 2023 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on the initiation of new patients in U.S. studies... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 21, 2023 Category: Pharmaceuticals Source Type: clinical trials

Valneva Announces PDUFA Date Extension for Chikungunya Virus Vaccine Candidate
Saint-Herblain (France), August 14, 2023– Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - August 14, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track designation to IVS-3001, a CAR-T Cell Therapy in the Treatment of Renal Cell Carcinoma
Houston, TX, USA, July 31, 2023– Invectys, Inc., a clinical-stage immuno-oncology company focused on developing novel therapies for advanced cancers, is pleased to announce the U.S. Food and Drug Administration (FDA) has granted Fast Track... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 31, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA Grants Fast Track Designation for Ambrx ’s ARX517 for the Treatment of Metastatic Castration-Resistant Prostate Cancer
SAN DIEGO, July 19, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma Inc., Ambrx (or the“Company”) (NASDAQ: AMAM), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Ambrx’s proprietary... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 19, 2023 Category: Pharmaceuticals Source Type: clinical trials

FDA grants traditional approval for Leqembi for the treatment of Alzheimer's disease
STOCKHOLM, July 7, 2023. BioArctic AB ' s partner Eisai announced today that the U.S. Food and Drug Administration, FDA, has approved the supplemental Biologics License Application, sBLA, supporting the traditional approval of LEQEMBI (lecanemab-irmb)... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - July 7, 2023 Category: Pharmaceuticals Source Type: clinical trials