Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C
Copenhagen, Denmark, September 16, 2020– Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response for the treatment of neurodegenerative orphan diseases, today announced that the U.S.... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 16, 2020 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Receives a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Terlipressin for the Treatment of Hepatorenal Syndrome Type 1 (HRS-1)
DUBLIN, Sept. 14, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 14, 2020 Category: Drugs & Pharmacology Source Type: news

Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Epsolay (benzoyl peroxide) for the Treatment of Inflammatory Lesions of Rosacea
NESS ZIONA, Israel, Sept. 10, 2020 (GLOBE NEWSWIRE) -- Sol-Gel Technologies, Ltd. (NASDAQ: SLGL), a clinical-stage dermatology company focused on identifying, developing and commercializing branded and generic topical drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 10, 2020 Category: Drugs & Pharmacology Source Type: news

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer
             Basel, 7 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto ™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verifica...
Source: Roche Investor Update - September 7, 2020 Category: Pharmaceuticals Source Type: news

Roche announces FDA approval of Gavreto (pralsetinib) for the treatment of adults with metastatic RET fusion-positive non-small cell lung cancer
             Basel, 7 September 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (US) Food and Drug Administration (FDA) has approved Gavreto ™ (pralsetinib) for the treatment of adults with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test. This indication was approved under the FDA’s Accelerated Approval programme, based on data from the phase I/II ARROW study. Continued approval for this indication may be contingent upon verifica...
Source: Roche Media News - September 7, 2020 Category: Pharmaceuticals Source Type: news

Alembic Pharma arm gets tentative USFDA nod for drug to treat pulmonary arterial hypertension
Alembic Global Holdings SA has received tentative approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) Treprostinil Injection in the strengths of 20 mg/20 ml (1 mg/ml), 50 mg/20 ml (2.5 mg/ml), 100 mg/20 ml (5 mg/ml), and 200 mg/20 ml (10 mg/ml), multiple-dose vials, Alembic Pharmaceuticals said in a regulatory filing. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - September 7, 2020 Category: Pharmaceuticals Source Type: news

Coronavirus (COVID-19) Update: Daily Roundup September 2, 2020
FDA ’s actions on a warning letter, an approved abbreviated new drug application, and an updated guidance in its ongoing response to the COVID-19 pandemic. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - September 3, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Mirum Pharmaceuticals Initiates Rolling Submission of a New Drug Application for Maralixibat for the Treatment of Cholestatic Pruritus in Patients with Alagille Syndrome and Launches Expanded Access Program
FOSTER CITY, Calif.--(BUSINESS WIRE)--Sep. 1, 2020-- Mirum Pharmaceuticals, Inc. (Nasdaq: MIRM), a biopharmaceutical company focused on the development and commercialization of novel therapies for debilitating liver diseases today... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - September 1, 2020 Category: Drugs & Pharmacology Source Type: news

Westminster-based Arca Biopharma is developing a treatment for Covid-19
Arca Biopharma is in the process of developing a Covid-19 treatment. The Westminster-based biotech company, which focuses on genetically targeted therapies for cardiovascular diseases, plans to submit its Investigational New Drug application with the U.S. Food and Drug Administration in September. The application is for AB201, a drug that has the potential to work as a treatment for severe Covid-19 patients, said Derek Cole, head of investor relations for the company. AB201 is a drug that Arca… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 28, 2020 Category: Pharmaceuticals Authors: Jensen Werley Source Type: news

Westminster-based Arca Biopharma is developing a treatment for Covid-19
Arca Biopharma is in the process of developing a Covid-19 treatment. The Westminster-based biotech company, which focuses on genetically targeted therapies for cardiovascular diseases, plans to submit its Investigational New Drug application with the U.S. Food and Drug Administration in September. The application is for AB201, a drug that has the potential to work as a treatment for severe Covid-19 patients, said Derek Cole, head of investor relations for the company. AB201 is a drug that Arca… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 28, 2020 Category: Biotechnology Authors: Jensen Werley Source Type: news

Coronavirus (COVID-19) Update: Daily Roundup August 28, 2020
The FDA approves an abbreviated new drug application for sedated and ventilated patients during the COVID-19 public health emergency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 28, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Alembic Pharmaceuticals gets USFDA's tentative approval for type 2 diabetes drug
The tentatively approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug product Glyxambi tablets, 10 mg/5 mg and 25 mg/5 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - August 27, 2020 Category: Pharmaceuticals Source Type: news

Abbreviated New Drug Application (ANDA) Forms and Submission Requirements
This page is a resource for ANDA Forms and Submission Requirements (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 26, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Coronavirus (COVID-19) Update: Daily Roundup August 25, 2020
FDA issues new Consumer Update and approves an Abbreviated New Drug Application during COVID-19 pandemic. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - August 25, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations
Tepotinib granted Priority Review and is being evaluated under FDA Real-Time Oncology Review (RTOR) pilot program Tepotinib is a highly targeted inhibitor of c-MET that is administered as a once-daily oral tablet Data show robust, consistent and dura... Biopharmaceuticals, Oncology, FDA EMD Serono, Merck KGaA, Tepotinib, NSCLC (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 25, 2020 Category: Pharmaceuticals Source Type: news

FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations
ROCKLAND, Mass., Aug. 25, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2020 Category: Drugs & Pharmacology Source Type: news

Sarepta Therapeutics Announces FDA Acceptance of Casimersen (SRP-4045) New Drug Application for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 45
CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 25, 2020 Category: Drugs & Pharmacology Source Type: news

Tricida Receives Complete Response Letter from the FDA for its New Drug Application for Veverimer for the Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Aug. 24, 2020-- Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed,... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 24, 2020 Category: Drugs & Pharmacology Source Type: news

After surprise rejection of hemophilia gene therapy, BioMarin asks FDA to approve dwarfism drug
A controversial drug to treat the most common form of dwarfism is heading for a federal regulator's decision. BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) of San Rafael said Thursday that it submitted its new drug application for the Food and Drug Administration to approve its drug, called vosoritide, as a once-daily injection for children with achondroplasia. The bone-growth disorder prevents cartilage fr om changing into bone. The application comes a day after the FDA rejected BioMarin's request… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 20, 2020 Category: Biotechnology Authors: Ron Leuty Source Type: news

After surprise rejection of hemophilia gene therapy, BioMarin asks FDA to approve dwarfism drug
A controversial drug to treat the most common form of dwarfism is heading for a federal regulator's decision. BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) of San Rafael said Thursday that it submitted its new drug application for the Food and Drug Administration to approve its drug, called vosoritide, as a once-daily injection for children with achondroplasia. The bone-growth disorder prevents cartilage fr om changing into bone. The application comes a day after the FDA rejected BioMarin's request… (Source: bizjournals.com Health Care:Pharmaceuticals headlines)
Source: bizjournals.com Health Care:Pharmaceuticals headlines - August 20, 2020 Category: Pharmaceuticals Authors: Ron Leuty Source Type: news

BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
Potential first treatment for achondroplasia in the United States European Regulatory Review Began on Aug. 13 SAN RAFAEL, Calif., Aug. 20, 2020 -- (Healthcare Sales & Marketing Network) -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced ... Biopharmaceuticals, FDA BioMarin Pharmaceutical, vosoritide, achondroplasia (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 20, 2020 Category: Pharmaceuticals Source Type: news

BioMarin Submits New Drug Application to U.S. Food and Drug Administration for Vosoritide to Treat Children with Achondroplasia
SAN RAFAEL, Calif., Aug. 20, 2020 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for vosoritide, an... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 20, 2020 Category: Drugs & Pharmacology Source Type: news

G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer
RESEARCH TRIANGLE PARK, N.C., Aug. 17, 2020 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 17, 2020 Category: Drugs & Pharmacology Source Type: news

TG Therapeutics Announces FDA Acceptance of New Drug Application for Umbralisib as a Treatment for Patients with Previously Treated Marginal Zone Lymphoma and Follicular Lymphoma
NEW YORK, Aug. 13, 2020 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Evinacumab Biologics License Application for Priority Review as a Treatment for Patients with HoFH, an Ultra-rare Inherited Form of High Cholesterol
TARRYTOWN, N.Y., Aug. 12, 2020 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for Priority Review a Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 13, 2020 Category: Drugs & Pharmacology Source Type: news

Innovent and Eli Lilly Announce Acceptance of a Supplemental New Drug Application of TYVYT(R) (Sintilimab Injection) in Combination with Gemcitabine and Platinum as First-Line Therapy in Squamous Non-Small Cell Lung Cancer in China
SUZHOU, China, Aug. 12, 2020 -- (Healthcare Sales & Marketing Network) -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the ... Biopharmaceuticals, Oncology, Regulatory Innovent Biologics, Eli Lilly, TYVYT, sintilimab, NSCLC (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - August 12, 2020 Category: Pharmaceuticals Source Type: news

Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its NDA for Pedmark To Prevent Ototoxicity Associated With Cisplatin
RESEARCH TRIANGLE PARK, N.C., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2020 Category: Drugs & Pharmacology Source Type: news

Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for Pedmark to Prevent Ototoxicity Associated With Cisplatin in Pediatric Patients with Localized, Non-Metastatic, Solid Tumors
RESEARCH TRIANGLE PARK, N.C. USA, August 11, 2020– Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, today announced that it received a Complete Response Letter (CRL) on August 10, 2020 from the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 11, 2020 Category: Drugs & Pharmacology Source Type: news

Gilead Submits New Drug Application to U.S. Food and Drug Administration for Veklury (remdesivir) for the Treatment of COVID-19
FOSTER CITY, Calif.--(BUSINESS WIRE)--Aug. 10, 2020-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Veklury (remdesivir), an investigational... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 10, 2020 Category: Drugs & Pharmacology Source Type: news

FDA Accepts Biogen ’s Aducanumab Biologics License Application for Alzheimer's Disease with Priority Review
CAMBRIDGE, Mass. and TOKYO, Aug. 07, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - August 7, 2020 Category: Drugs & Pharmacology Source Type: news

Vanda steps closer to potential FDA approval for rare developmental disorder treatment
Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) is moving closer to a potential regulatory approval for a developmental disorder treatment, nearly five months after the Food and Drug Administration refused to accept the company ’s application for it. The D.C. biotech said Monday the agency has accepted for priority review its application for Smith-Magenis Syndrome, which includes two components: a supplemental new drug application for a solid capsule formulation of Hetlioz, for adults with SMS, and a… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - August 3, 2020 Category: Biotechnology Authors: Sara Gilgore Source Type: news

Janssen Announces U.S. FDA Approval of SPRAVATO ® (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
TITUSVILLE, N.J. – (August 3, 2020) – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for SPRAVATO® (esketamine) CIII nasal spray, taken with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder (MDD) with acute suicidal ideation orbehavior.1 SPRAVATO® is the first and only approved medicine that has been shown to reduce depressive symptoms within 24 hours,1 providing a new option for significant symptom relief until a longer-te...
Source: Johnson and Johnson - August 3, 2020 Category: Pharmaceuticals Tags: Innovation Source Type: news

FDA Approves Spravato (esketamine) CIII Nasal Spray to Treat Depressive Symptoms in Adults with Major Depressive Disorder with Acute Suicidal Ideation or Behavior
TITUSVILLE, N.J.– (August 3, 2020)– The Janssen Pharmaceutical Companies of Johnson& Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Spravato... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - August 3, 2020 Category: Drugs & Pharmacology Source Type: news

Bristol Myers Squibb and bluebird bio Announce Submission of Biologics License Application (BLA) to FDA for Idecabtagene Vicleucel (Ide-cel, bb2121) for Adults with Relapsed and Refractory Multiple Myeloma
PRINCETON, N.J.,& CAMBRIDGE, Mass.-- July 29, 2020 -- (BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) and bluebird bio, Inc. (Nasdaq: BLUE) today announced the submission of their Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 29, 2020 Category: Drugs & Pharmacology Source Type: news

scPharmaceuticals Announces FDA Acceptance of Furoscix New Drug Application Resubmission
BURLINGTON, Mass.--(BUSINESS WIRE)--Jul. 27, 2020-- scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 27, 2020 Category: Drugs & Pharmacology Source Type: news

Jazz Pharmaceuticals expands sleep disorder drug portfolio with FDA approval of Xywav
The Food and Drug Administration has approved Jazz Pharmaceuticals' new drug application for Xywav, a new sleep disorder drug. Xywav was approved by the FDA, Tuesday night, to treat cataplexy or excessive daytime sleepiness in patients 7 years of age and older with narcolepsy. Jazz stock was up nearly 4.6% to $110.34 per share in early morning trading. Narcolepsy is a chronic sleep disorder characterized by overwhelming daytime drowsiness and sudden attacks of sleep. People with narcolepsy often… (Source: bizjournals.com Health Care:Biotechnology headlines)
Source: bizjournals.com Health Care:Biotechnology headlines - July 22, 2020 Category: Biotechnology Authors: John George Source Type: news

Aurinia Announces U.S. Food and Drug Administration Acceptance of the Filing of New Drug Application and Priority Review for Voclosporin for the Treatment of Lupus Nephritis
VICTORIA, British Columbia& ROCKVILLE, Md.--(BUSINESS WIRE) July 21, 2020 -- Aurinia Pharmaceuticals Inc. (Nasdaq:AUPH / TSX:AUP) (“Aurinia” or the“Company”), a late-stage clinical biopharmaceutical company focused on... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 21, 2020 Category: Drugs & Pharmacology Source Type: news

Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C
Copenhagen, Denmark, July 20, 2020– Orphazyme A/S (ORPHA.CO), a late-stage biopharmaceutical company pioneering the Heat-Shock Protein response in order to develop and commercialize novel therapeutics for the treatment of... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 20, 2020 Category: Drugs & Pharmacology Source Type: news

16.07.20: Not intended for U.S. and UK Media
U.S. FDA grants priority review to New Drug Application for vericiguat to treat chronic heart failuremehr ... (Source: Bayer IR Newsfeed: Events)
Source: Bayer IR Newsfeed: Events - July 16, 2020 Category: Pharmaceuticals Source Type: news

U.S. FDA grants priority review to New Drug Application for vericiguat to treat chronic heart failure (for specialized target groups only)
(Source: Bayer Company News)
Source: Bayer Company News - July 16, 2020 Category: Pharmaceuticals Source Type: news

FDA Grants Priority Review to Merck ’s New Drug Application for Vericiguat
KENILWORTH, N.J.--(BUSINESS WIRE) July 16, 2020 -- Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has accepted for priority review the New Drug Application (NDA)... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 16, 2020 Category: Drugs & Pharmacology Source Type: news

Mallinckrodt Announces U.S. Food and Drug Administration (FDA) Advisory Committee Voted to Recommend Terlipressin for Approval to Treat Patients with Hepatorenal Syndrome Type 1 (HRS-1)
DUBLIN, July 15, 2020 /PRNewswire/ -- Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced that the Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 15, 2020 Category: Drugs & Pharmacology Source Type: news

Roche collaborates with Blueprint Medicines to bring a new treatment to people with RET-altered cancers
             Basel, 14 July 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Blueprint Medicines Corporation (NASDAQ:BPMC), today announced the signing of a licensing and collaboration agreement providing exclusive rights to Roche for global co-development and commercialisation outside the United States (US), excluding Greater China*. In the US, Genentech, a member of the Roche Group, will obtain co-commercialisation rights to pralsetinib, Blueprint Medicine ’s investigational, once-daily oral precision therapy for the treatment of people with RET-altered ...
Source: Roche Media News - July 14, 2020 Category: Pharmaceuticals Source Type: news

Verrica Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for VP-102 for the Treatment of Molluscum Contagiosum
WEST CHESTER, Pa., July 14, 2020 (GLOBE NEWSWIRE) -- Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for viral skin diseases requiring medical... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 14, 2020 Category: Drugs & Pharmacology Source Type: news

ChemoCentryx Submits New Drug Application to the U.S. FDA for Avacopan in ANCA-Associated Vasculitis
MOUNTAIN VIEW, Calif., July 09, 2020 (GLOBE NEWSWIRE) -- ChemoCentryx, Inc., (NASDAQ: CCXI) today confirmed that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 9, 2020 Category: Drugs & Pharmacology Source Type: news

Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer ’s Disease
CAMBRIDGE, Mass. and TOKYO, July 08, 2020 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai Co., Ltd. (Tokyo, Japan) today announced that Biogen has completed the submission of a Biologics License Application (BLA) to the U.S. Food and Drug... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 8, 2020 Category: Drugs & Pharmacology Source Type: news

Unichem Labs gets USFDA nod to market muscle spasm tablets
The company has received abbreviated new drug application (ANDA) approval to market its Cyclobenzaprine Hydrochloride tablets USP 5 mg, 7.5 mg and 10 mg from the United States Food and Drug Administration (USFDA), Unichem Labs said in a filing to the BSE. (Source: The Economic Times Healthcare and Biotech News)
Source: The Economic Times Healthcare and Biotech News - July 7, 2020 Category: Pharmaceuticals Source Type: news

Merck initiates first clinical trial of TLR7 and 8 inhibitor as a potential treatment for severe symptoms of COVID-19 infection
Merck, a leading science and technology company, announced the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for M5049 for the treatment of patients with Covid-19 pneumonia. Merck will initiate a Phase II randomized, controlled clinical study evaluating the safety and efficacy of M5049 in this patient population. (Source: World Pharma News)
Source: World Pharma News - July 3, 2020 Category: Pharmaceuticals Tags: Featured Merck Group Business and Industry Source Type: news

Blueprint Medicines Announces Submission of New Drug Application to FDA for Pralsetinib for the Treatment of Advanced RET Mutant and RET Fusion-Positive Thyroid Cancers
CAMBRIDGE, Mass., July 1, 2020 /PRNewswire/ -- Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced the... (Source: Drugs.com - New Drug Applications)
Source: Drugs.com - New Drug Applications - July 1, 2020 Category: Drugs & Pharmacology Source Type: news