' Impressive' Results for Novel Antidepressant, So Why the FDA Delay?'Impressive' Results for Novel Antidepressant, So Why the FDA Delay?
AXS-05, a combination of dextromethorphan and bupropion, appears to have a rapid and durable effect in major depression, yet its new drug application remains in FDA limbo.Medscape Medical News (Source: Medscape Neurology and Neurosurgery Headlines)
Source: Medscape Neurology and Neurosurgery Headlines - October 13, 2021 Category: Neurology Tags: Psychiatry News Source Type: news

U.S. FDA Accepts COUR Pharmaceuticals Investigational New Drug Application (IND) for a Proof-of-Concept Study for the Treatment of Primary Biliary Cholangitis (PBC)
Clinical study aims to investigate the safety and efficacy of CNP-104 in PBC patients with alkaline phosphatase (ALP)> 1.5x upper limit of normal (ULN) CHICAGO, Oct. 4, 2021 -- (Healthcare Sales & Marketing Network) -- COUR Pharmaceuticals, a biote... Biopharmaceuticals, FDA COUR Pharmaceuticals, Primary Biliary Cholangitis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - October 6, 2021 Category: Pharmaceuticals Source Type: news

New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO ® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
RARITAN, NJ, September 27, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today new data from the Phase 3 UNIVERSE study showing treatment with XARELTO® (rivaroxaban) in an oral suspension formulation, compared to treatment with aspirin, was associated with numerically fewer blood clots and clinical events strongly associated with blood clots in pediatric patients (aged 2-8 years) who have undergone the Fontan procedure. [1] These findings, which were published this month in the Journal of the American Heart Association and included in a recent New Drug Application submitted to the...
Source: Johnson and Johnson - September 27, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Pittsburgh-based biotech company on a growth path
NeuBase Therapeutics Inc., the Pittsburgh-based biotechnology company, has expanded in the city as well as in Massachusetts as it prepares for the investigational new drug application of its first candidate in its pipeline. NeuBase (Nasdaq: NBSE) recently opened its headquarters at The Riveria on Technology Drive in South Oakland amid other biotechnology firms and also opened a clinical and business development office in Cambridge, Massachusetts. And the company is continuing to develop its therapy… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 21, 2021 Category: Pharmaceuticals Authors: Paul J. Gough Source Type: news

Pittsburgh-based biotech company on a growth path
NeuBase Therapeutics Inc., the Pittsburgh-based biotechnology company, has expanded in the city as well as in Massachusetts as it prepares for the investigational new drug application of its first candidate in its pipeline. NeuBase (Nasdaq: NBSE) recently opened its headquarters at The Riveria on Technology Drive in South Oakland amid other biotechnology firms and also opened a clinical and business development office in Cambridge, Massachusetts. And the company is continuing to develop its therapy… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - September 21, 2021 Category: Biotechnology Authors: Paul J. Gough Source Type: news

Verrica Pharmaceuticals stock drops following another setback for its lead drug candidate
The Food and Drug Administration has once again delayed a decision on a West Chester pharmaceutical company's lead new drug application, but the issue has nothing to do with the experimental drug's effectiveness. Instead, Verrica Pharmaceuticals said Tuesday, the federal agency identified deficiencies at a facility of a contract manufacturing organization that makes Verrica's experimental drug known as VP-102. The alleged deficiencies, the company said, are not specifically related to the manufacturing… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - September 21, 2021 Category: Pharmaceuticals Authors: John George Source Type: news

Zydus Cadila gets US Food and Drug Administration nod for diabetes medication
On October 31, 2020, Zydus had filed a new drug application (NDA) with the USFDA seeking approval to market Sitagliptin base 25, 50 and 100 mg tablets. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 6, 2021 Category: Pharmaceuticals Source Type: news

FDA Acceptance for Filing of New Drug Application (NDA) for Trientine Tetrahydrochloride (TETA 4HCl) for the treatment of Wilson ’s Disease
NDA supported by positive data from Phase 3 CHELATE clinical trial TETA 4-HCl previously granted Orphan Drug Designation for first-line treatment of Wilson’s Disease Paris, France– 02 September 2021 – Orphalan SA, a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 2, 2021 Category: Drugs & Pharmacology Source Type: news

Coherus and Junshi Biosciences Announce Completion of Rolling BLA Submission to U.S. FDA for Toripalimab for the Treatment of Nasopharyngeal Carcinoma
SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 01, 2021 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus Biosciences, Inc. (“Coherus”, Nasdaq: CHRS)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2021 Category: Drugs & Pharmacology Source Type: news

Johnson & Johnson and Global Partners Announce Results from Phase 2b Imbokodo HIV Vaccine Clinical Trial in Young Women in Sub-Saharan Africa
This study is being conducted in the Americas and Europe where different strains of HIV are circulating. Given these differentiating factors and following consultations with the Mosaico study independent Data and Safety Monitoring Board (DSMB), it was decided that the Mosaico study will continue at this time. “We are extremely grateful to the women who volunteered for the Imbokodo study, and to our partners, including the people on the frontlines, all of whom are contributing every day to this enduring quest to make HIV history,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scien...
Source: Johnson and Johnson - August 31, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-BCMA-ALLO1, an Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma
SAN DIEGO, Aug. 30, 2021 -- (Healthcare Sales & Marketing Network) -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutic... Biopharmaceuticals, Oncology, FDA Poseida Therapeutics, multiple myeloma (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 30, 2021 Category: Pharmaceuticals Source Type: news

Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer
Recommendations for sponsors of investigational new drug applications (INDs) and biologics license applications (BLAs) on the use of pharmacokinetic (PK)-based criteria to support the approval of alternative dosing regimens for PD-1 or PD-L1 blocking antibodies. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 25, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Moderna Completes Submission of Biologics License Application to the U.S. Food and Drug Administration for its COVID-19 Vaccine
Final blinded analysis of Phase 3 COVE study of the Moderna COVID-19 vaccine shows 93% efficacy; efficacy remains durable through six months after second dose CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 25, 2021-- Moderna, Inc. (Nasdaq:... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2021 Category: Drugs & Pharmacology Source Type: news

Pfizer and BioNTech Initiate Rolling Submission of Supplemental Biologics License Application to U.S. FDA for Booster Dose of Comirnaty in Individuals 16 and Older
New Phase 3 data show booster (third) dose of Comirnaty induces significant SARS-CoV-2 neutralizing antibody titers and demonstrated a favorable safety and tolerability profile SARS-CoV-2 neutralizing titers against the wild-type strain one month... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2021 Category: Drugs & Pharmacology Source Type: news

Stealth BioTherapeutics Submits Elamipretide New Drug Application to FDA for Treatment of Barth Syndrome
BOSTON, Aug. 24, 2021 /PRNewswire/ -- Stealth BioTherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 24, 2021 Category: Drugs & Pharmacology Source Type: news

Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke Kit for the Treatment of Severe Hypoglycemia
First ready-to-use liquid glucagon available in a single-dose vial and syringe kit for rescue Gvoke HypoPen®, Gvoke® PFS, and Gvoke® Kit– three different administration options to accommodate patients’ preferences Gvoke... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 23, 2021 Category: Drugs & Pharmacology Source Type: news

Axsome Therapeutics Provides Update on the New Drug Application for AXS-05 for the Treatment of Major Depressive Disorder
NEW YORK, Aug. 23, 2021 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, today announced that... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 23, 2021 Category: Drugs & Pharmacology Source Type: news

Zydus Cadila gets USFDA nod for arthritis drug with 180-days exclusivity
Zydus was the first abbreviated new drug application (ANDA) filer on Tofacitinib extended-release tablets 22 mg and thus holds 180-day exclusivity on this strength, the company said in a statement. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 23, 2021 Category: Pharmaceuticals Source Type: news

Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application
Biopharmaceutics (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 20, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Agios Announces FDA Acceptance and Priority Review of New Drug Application for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency
CAMBRIDGE, Mass., Aug. 17, 2021 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism developing and delivering innovative treatments for genetically defined diseases, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 17, 2021 Category: Drugs & Pharmacology Source Type: news

Sesen Bio Receives Complete Response Letter from FDA for Vicineum (oportuzumab monatox-qqrs)
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Aug. 13, 2021-- Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, today announced that it received a... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2021 Category: Drugs & Pharmacology Source Type: news

Ipsen Announces Withdrawal of Palovarotene NDA, Confirming Intention to Resubmit Following Additional Data Analyses
Paris (France), Friday 13 August, 2021– Ipsen (Euronext: IPN; ADR: IPSEY) today announced, following very recent discussions with the U.S. Food and Drug Administration (FDA), withdrawal of the New Drug Application (NDA) for palovarotene.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2021 Category: Drugs & Pharmacology Source Type: news

FibroGen Receives Complete Response Letter from the FDA for Roxadustat for Anemia of Chronic Kidney Disease
SAN FRANCISCO, Aug. 11, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2021 Category: Drugs & Pharmacology Source Type: news

Dermavant Announces FDA Acceptance for Filing of New Drug Application (NDA) for Tapinarof Cream for the Treatment of Adults with Plaque Psoriasis
LONG BEACH, Calif.& BASEL, Switzerland--(BUSINESS WIRE) August 10, 2021 --Dermavant Sciences, a clinical-stage biopharmaceutical company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, today announced... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 10, 2021 Category: Drugs & Pharmacology Source Type: news

Dar é Bioscience Announces FDA Acceptance and Priority Review of New Drug Application for DARE-BV1 for the Treatment of Bacterial Vaginosis
SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced that the U.S. Food and Drug Administration (FDA) accepted for filing the company’s New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 9, 2021 Category: Drugs & Pharmacology Source Type: news

Spectrum Pharmaceuticals Receives Complete Response Letter from FDA for Rolontis (eflapegrastim)
HENDERSON, Nev.--(BUSINESS WIRE)--Aug. 6, 2021-- Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced receipt of a Complete Response Letter (CRL) from the U.S. Food... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 6, 2021 Category: Drugs & Pharmacology Source Type: news

Breckenridge Announces Final Approval of its ANDA for Apixaban Tablets (generic for Eliquis(R))
BERLIN, Conn., Aug. 5, 2021 -- (Healthcare Sales & Marketing Network) -- Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Apixaban Tablets (... Biopharmaceuticals, Generics, FDA Breckenridge Pharmaceutical, Apixaban, Eliquis (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 5, 2021 Category: Pharmaceuticals Source Type: news

FDA Rejects Tenapanor for Control of Phosphorus in Kidney Disease FDA Rejects Tenapanor for Control of Phosphorus in Kidney Disease
An additional trial showing a'clinically relevant treatment effect'needed for approval in patients with kidney disease on dialysis, says the FDA in response to a new drug application.Medscape Medical News (Source: Medscape Medical News Headlines)
Source: Medscape Medical News Headlines - August 5, 2021 Category: Consumer Health News Tags: Nephrology News Source Type: news

Alembic Pharma gets final approval from USFDA for OCD treatment drug
The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Clomipramine Hydrochloride Capsules USP in the strengths 25 mg, 50 mg, and 75 mg, Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 5, 2021 Category: Pharmaceuticals Source Type: news

Marinus Pharmaceuticals Submits New Drug Application (NDA) to FDA for Ganaxolone for the Treatment of Seizures Associated with CDKL5 Deficiency Disorder and Provides Pipeline Update
RADNOR, Pa.--(BUSINESS WIRE)--August 3, 2021 -- Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 3, 2021 Category: Drugs & Pharmacology Source Type: news

GSK Files for Licensure of Priorix MMR Vaccine in the US
August 2, 2021 -- GSK today announced it has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for Priorix (Measles, Mumps, and Rubella Virus Vaccine, Live) and is seeking approval for use in active... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 2, 2021 Category: Drugs & Pharmacology Source Type: news

UPTRAVI ® (selexipag) Receives FDA Approval for Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)
TITUSVILLE, N.J. – July 30, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy. UPTRAVI® IV is a therapeutic option that will allow patients to avoid short-term treatment interruptions and stay on UPTRAVI® therapy, as uninterrupted treatment is considered key for individ...
Source: Johnson and Johnson - July 30, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Ardelyx Receives Complete Response Letter from U.S. FDA for New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
FREMONT, Calif. and WALTHAM, Mass., July 29, 2021 /PRNewswire/ -- Ardelyx Inc.,(Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 29, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Application for Genentech ’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)
South San Francisco, CA -- July 28, 2021 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA),... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

Mycovia Pharmaceuticals Announces U.S. FDA Acceptance and Priority Review of New Drug Application for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis
 DURHAM, N.C.--(BUSINESS WIRE) July 28, 2021 --Mycovia Pharmaceuticals, Inc. (Mycovia), an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies, today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 28, 2021 Category: Drugs & Pharmacology Source Type: news

Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem
DUBLIN, Ireland and CHICAGO, July 26, 2021 (GLOBE NEWSWIRE) -- Iterum Therapeutics plc (Nasdaq: ITRM) (the“Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Braeburn ’s New Drug Application Resubmission for Brixadi (buprenorphine) Extended-Release Subcutaneous Injection for Moderate to Severe Opioid Use Disorder
Plymouth Meeting, Pa.– June 26, 2021– Braeburn announces that the New Drug Application (NDA) for Brixadi (buprenorphine) extended-release weekly and monthly injection for subcutaneous (SC) use (CIII) for moderate to severe opioid use... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 26, 2021 Category: Drugs & Pharmacology Source Type: news

Johnson & Johnson Reports Q2 2021 Results
New Brunswick, N.J. (July 21, 2021) – Johnson & Johnson (NYSE: JNJ) today announced results for second-quarter. “Our second-quarter results showcase Johnson & Johnson’s diversified portfolio, driven by strong sales and earnings growth across our Medical Device, Consumer Health and Pharmaceutical businesses,” said Alex Gorsky, Chairman and Chief Executive Officer. “I’m so proud of our 136,000 colleagues who remain focused on delivering our medicines and products to patients and consumers around the world, in addition to advancing our pipeline with new product launches and regulato...
Source: Johnson and Johnson - July 21, 2021 Category: Pharmaceuticals Tags: Our Company Source Type: news

U.S. Food and Drug Administration Expands Indication for Prograf for Prevention of Organ Rejection in Adult and Pediatric Lung Transplant Recipients
NORTHBROOK, Ill., July 20, 2021 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., " Astellas " ) announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news

Ardelyx Provides Regulatory Update on New Drug Application for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
FREMONT, Calif. and WALTHAM, Mass., July 19, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

Aquestive Therapeutics Announces FDA Acceptance of New Drug Application (NDA) Resubmission for Libervant (diazepam) Buccal Film
WARREN, N.J., July 19, 2021 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a pharmaceutical company focused on developing and commercializing differentiated products that address patients’ unmet needs and solve therapeutic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

Status on FDA Advisory Committee Vote on Roxadustat in Anemia of Chronic Kidney Disease
16 July 2021 -- The Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) has voted 13 to 1 that the benefit-risk profile of roxadustat does not support approval for the treatment of anemia in chronic... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

Alembic Pharma gets USFDA nod for cancer treatment drug
The company has received final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Erlotinib tablets in the strengths of 25 mg, 100 mg, and 150 mg, Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 9, 2021 Category: Pharmaceuticals Source Type: news

Clinical Data Summary Pilot Program
CDER has launched a pilot program to assess the feasibility of using a different format to provide required summaries of the safety and effectiveness information that is used to make regulatory decisions. The pilot program will include up to nine recently submitted new drug applications (NDAs). (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 8, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Tezepelumab Granted Priority Review By U.S. FDA
THOUSAND OAKS, Calif., July 7, 2021 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 7, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Grants Priority Review for Levo Therapeutics ’ New Drug Application for LV-101 (Intranasal Carbetocin) for the Treatment of Prader-Willi Syndrome
CHICAGO, IL, July 6, 2021 (Newswire.com) – Levo Therapeutics, Inc., a biotechnology company dedicated to using genetic insights to advance treatments for Prader-Willi syndrome (PWS) and related disorders, announced today that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 6, 2021 Category: Drugs & Pharmacology Source Type: news

Provention Bio Receives Complete Response Letter (CRL) to Biologics License Application (BLA) for Teplizumab for the Delay of Clinical Type 1 Diabetes (T1D) in At-Risk Individuals
RED BANK, N.J., July 6, 2021 /PRNewswire/ -- Provention Bio, Inc. (Nasdaq: PRVB), a biopharmaceutical company dedicated to intercepting and preventing immune-mediated disease, today announced that the U.S. Food and Drug Administration... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 6, 2021 Category: Drugs & Pharmacology Source Type: news

Assessment of Adhesion for Topical and Transdermal Systems Submitted in New Drug Applications
Clinical Medicine (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - July 1, 2021 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis
BALTIMORE, July 1, 2021 /PRNewswire/ --Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Accepts Filing of Hutchmed ’s NDA for Surufatinib for the Treatment of Advanced Neuroendocrine Tumors
Hong Kong, Shanghai& Florham Park, NJ— Thursday, July 1, 2021: Hutchmed (China) Limited (“Hutchmed”) (Nasdaq/AIM: HCM; HKEX: 13) today announces that the U.S. Food and Drug Administration (“FDA”) has accepted its... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 1, 2021 Category: Drugs & Pharmacology Source Type: news