Drugs.com - New Drug Applications New drug applications news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals.
-
FDA Accepts Submission to Add PH-ILD to Yutrepia™ Label
on September 25, 2023 at 1:09 am
MORRISVILLE, N.C., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Liquidia Corporation (the Company) (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Company’s amendment to the tentatively approved...
-
Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)
on September 20, 2023 at 12:09 am
OSAKA, Japan and CAMBRIDGE, Massachusetts, September 20, 2023 – Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721...
-
UCB Provides Update on U.S. Regulatory Review of Bimekizumab
on September 19, 2023 at 11:09 pm
Brussels (Belgium), 19 September 2023 – UCB, a global biopharmaceutical company, today provided an update on the Biologics License Application (BLA) for bimekizumab for the treatment of adults with moderate to severe plaque psoriasis. UCB has...
-
FDA Issues Complete Response Letter for neffy® (epinephrine nasal spray) New Drug Application with Request for Additional Study
on September 19, 2023 at 8:09 pm
Company aligned with FDA in August 2023 on both physician labeling and post-market requirements, which included a repeat-dose study of neffy under allergen-induced allergic rhinitis conditions FDA Advisory Committee (PADAC), held in May 2023,...
-
Orchard Therapeutics Announces Acceptance of Biologics License Application for OTL-200 in MLD and Receives Priority Review
on September 18, 2023 at 6:09 am
PDUFA date set for March 18, 2024 OTL-200 would be the first and only treatment in the U.S. for early-onset MLD Previously published data demonstrated administration of one-time gene therapy enables sustained preservation of motor function and...
-
Madrigal Pharmaceuticals Announces NDA Acceptance and Priority Review of the New Drug Application for Resmetirom for the Treatment of NASH with Liver Fibrosis
on September 13, 2023 at 5:09 am
CONSHOHOCKEN, Pa., Sept. 13, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food...
-
Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
on September 11, 2023 at 11:09 pm
Overall response rate (ORR) greater than 50% across three assessment criteria Median duration of tovorafenib treatment of 15.8 months as of June 5, 2023, with 66% of patients remaining on treatment FDA filing decision expected by...
-
Verona Pharma Announces the US FDA has Accepted the New Drug Application Filing for Ensifentrine for the Maintenance Treatment of COPD
on September 11, 2023 at 10:09 pm
PDUFA Target Action Date of June 26, 2024 Ensifentrine, if approved, is expected to be the first novel mechanism available for the maintenance treatment of COPD in more than a decade LONDON and RALEIGH, N.C., Sept. 11, 2023 (GLOBE NEWSWIRE) --...
-
Aquestive Therapeutics Receives FDA Acceptance Of New Drug Application (NDA) For Libervant (Diazepam) Buccal Film In Pediatric Patients And Assignment Of Prescription Drug User Fee Act (PDUFA) Date
on September 11, 2023 at 12:09 am
FDA Acceptance of Libervant™ (diazepam) Buccal Film NDA for treatment of seizure clusters in patients between two and five years of age Prescription Drug User Fee Act (PDUFA) target goal date set for April 28, 2024 WARREN, N.J., Sept....
-
X4 Pharmaceuticals Announces Submission of New Drug Application (NDA) to U.S. FDA for Mavorixafor in WHIM Syndrome
on September 5, 2023 at 2:09 am
BOSTON, Sept. 05, 2023 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced the submission of a New Drug Application (NDA) to the United...
-
FDA Accepts Application for Genentech’s Crovalimab for the Treatment of PNH, a Rare Life-Threatening Blood Condition
on September 4, 2023 at 6:09 am
South San Francisco, CA -- September 4, 2023 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application...
-
Geron Announces PDUFA Date for Imetelstat NDA in Lower Risk MDS
on August 22, 2023 at 1:08 am
FOSTER CITY, Calif.--(BUSINESS WIRE) August 22, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has assigned a standard review and...
-
Phathom Pharmaceuticals Announces Submission of Six-Month Stability Data in Support of Erosive GERD New Drug Application for Vonoprazan
on August 21, 2023 at 2:08 am
Six-month stability data remain more than 10x below the acceptable intake limit set by the U.S. Food and Drug Administration (FDA) and continue to support the requested product shelf life Submission of six-month stability data satisfies Phathom's...
-
Geron Announces FDA Acceptance of New Drug Application for Imetelstat for the Treatment of Lower Risk MDS
on August 21, 2023 at 1:08 am
FOSTER CITY, Calif.--(BUSINESS WIRE) August 21, 2023 -- Geron Corporation (Nasdaq: GERN), a late-stage clinical biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has accepted the filing of...
-
Venatorx Pharmaceuticals Announces FDA Acceptance and Priority Review of New Drug Application for Cefepime-Taniborbactam to Treat Complicated Urinary Tract Infections (cUTI), including Pyelonephritis, in Adults
on August 15, 2023 at 12:08 am
Cefepime-taniborbactam has also demonstrated in vitro activity against CDC Urgent and Serious Threat Pathogens carbapenem-resistant Enterobacterales, multidrug-resistant Pseudomonas aeruginosa and Extended Spectrum Beta-lactamase-producing...
-
Galera Receives Complete Response Letter from U.S. FDA for Avasopasem Manganese
on August 9, 2023 at 3:08 am
MALVERN, Pa., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to...
-
Basilea Announces Submission of a New Drug Application to the US Food and Drug Administration for its Antibiotic Ceftobiprole
on August 4, 2023 at 6:08 am
Allschwil, Switzerland, August 04, 2023 -- Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today...
-
Madrigal Pharmaceuticals Completes Submission of New Drug Application Seeking Accelerated Approval of Resmetirom for the Treatment of NASH with Liver Fibrosis
on July 17, 2023 at 1:07 am
CONSHOHOCKEN, Pa., July 17, 2023 (GLOBE NEWSWIRE) -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a clinical-stage biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), announced the completion of the...
-
Elevar Therapeutics Announces FDA Acceptance for Filing of New Drug Application for Rivoceranib in Combination with Camrelizumab as a First-line Treatment for Unresectable Hepatocellular Carcinoma
on July 17, 2023 at 1:07 am
FORT LEE, NEW JERSEY, July 17, 2023 – Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. And a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for patients who have...
-
FDA Issues Complete Response Letter for PDP-716 NDA Due to Inspection Findings at Third-Party API Manufacturing Facility
on July 13, 2023 at 11:09 pm
No issues with clinical efficacy or safety were identified in the CRL No additional clinical data or trials have been requested Mumbai, India, July 13, 2023 - Sun Pharma Advanced Research Company Ltd. (Reuters: SPRC.BO, Bloomberg: SPADV IN,...
