Drugs

PLAINSBORO, N.J., Dec. 4, 2020 /PRNewswire/ – Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) approved an updated label for Saxenda® (liraglutide) injection 3 mg for use in the treatment of obesity in adolescents (12–17 years) with a body weight above 60 kg and an initial body mass index (BMI) corresponding to 30 kg/m2 or greater

Treatment for Attention Deficit Hyperactivity Disorder (ADHD) Supernus Provides Regulatory Update for SPN-812 ROCKVILLE, Md., Nov. 09, 2020 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced a regulatory update for SPN-812 (viloxazine hydrochloride) for the

FDA Approves Orladeyo (berotralstat) as the First Oral, Once-Daily Therapy to Prevent Attacks in Hereditary Angioedema Patients RESEARCH TRIANGLE PARK, N.C., Dec. 03, 2020 (GLOBE NEWSWIRE) — BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the U.S. Food and Drug Administration (FDA) has approved oral, once-daily Orladeyo (berotralstat) for prophylaxis to prevent attacks of hereditary

Treatment for Opioid Overdose Adamis Pharmaceuticals Receives a Complete Response Letter from the FDA Regarding Zimhi SAN DIEGO, Nov. 16, 2020 (GLOBE NEWSWIRE) — Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) (“Adamis”) today announced that after the close of business and the U.S. markets on November 13th, it received a Complete Response Letter (CRL) from the U.S.

South San Francisco, CA — December 1, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Gavreto™ (pralsetinib) for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic rearranged during

pegcetacoplan Treatment for Paroxysmal Nocturnal Hemoglobinuria Apellis Announces FDA Acceptance and Priority Review of the New Drug Application for Pegcetacoplan for the Treatment of PNH WALTHAM, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) – Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA)

Treatment for Schizophrenia, Bipolar Disorder Alkermes Receives FDA Complete Response Letter Related to ALKS 3831 Manufacturing Records Review DUBLIN, Nov. 17, 2020 /PRNewswire/ – Alkermes plc (Nasdaq: ALKS) today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults

Treatment for Prevention of Catheter Related Blood Stream Infections (CRBSI) CorMedix Inc. Announces FDA Decision That Advisory Committee Meeting for New Drug Application for Defencath is Not Needed Berkeley Heights, NJ – November 18, 2020 – CorMedix Inc. (NYSE American: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of

News FDA Alerts FDA Alerts Healthcare Professionals About the Risk of Medication Errors with Tranexamic Acid Injection Resulting in Inadvertent Intrathecal (Spinal) Injection December 3, 2020 Audience: Healthcare Professionals December 3, 2020 — The U.S. Food and Drug Administration is alerting health care professionals about the risk of inadvertent intrathecal administration of tranexamic acid injection.

Treatment for Pulmonary Arterial Hypertension (PAH) Liquidia Receives Complete Response Letter from FDA for LIQ861 (treprostinil) Inhalation Powder for the Treatment of Pulmonary Arterial Hypertension RESEARCH TRIANGLE PARK, N.C., Nov. 25, 2020 (GLOBE NEWSWIRE) – Liquidia Technologies, Inc., a wholly owned subsidiary of Liquidia Corporation (NASDAQ: LQDA), today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response

December 2, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy December 2, 2020 — Mesquite, TX MPM Medical is voluntarily recalling one lot of Regenecare HA Hydrogel to the consumer level. Following two customer complaints of visible contamination, the product was found to be contaminated with the bacteria Burkholderia cepecia. Risk Statement: Topical application of Regenecare

FDA Approves Danyelza (naxitamab-gqgk) for the Treatment of Neuroblastoma NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) — Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration

FDA Approves Imcivree (setmelanotide) for Chronic Weight Management in Patients with Obesity Due to POMC, PCSK1 or LEPR Deficiency BOSTON, Nov. 27, 2020 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq:RYTM), a biopharmaceutical company aimed at developing and commercializing therapies for the treatment of rare genetic diseases of obesity, announced today that the U.S. Food &

ATLANTA, Nov. 17, 2020 /PRNewswire/ — UCB, a global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Vimpat (lacosamide) CV as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients four years of age and older and Vimpat injection for intravenous use in children four

South San Francisco, CA — November 23, 2020 — Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) as a treatment to prevent influenza in people 12 years of age and

FDA Approves Oxlumo (lumasiran) for the Treatment of Primary Hyperoxaluria Type 1 CAMBRIDGE, Mass.–(BUSINESS WIRE)–Nov. 24, 2020– Alnylam Pharmaceuticals, Inc. (Nasdaq:ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) approved Oxlumo (lumasiran) injection for subcutaneous use, the first-ever therapy available for the treatment of primary hyperoxaluria type 1

20 November 2020 –  AstraZeneca’s Imfinzi (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small cell lung cancer (NSCLC) after chemoradiation therapy (CRT) and previously treated advanced bladder cancer. This new option is consistent with the

November 19, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy November 19, 2020 — Fresenius Kabi USA is voluntarily recalling a single lot of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg /mL), 50 mL fill in a 50 mL vial. Fresenius Kabi initiated this recall due to a trace amount of

FDA Approves Zokinvy (lonafarnib) for Hutchinson-Gilford Progeria Syndrome and Processing-Deficient Progeroid Laminopathies PALO ALTO, Calif., Nov. 20, 2020 /PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved Zokinvy (lonafarnib) for the

vosoritide Treatment for Achondroplasia FDA Accepts BioMarin’s New Drug Application for Vosoritide to Treat Children with Achondroplasia SAN RAFAEL, Calif., Nov. 2, 2020 /PRNewswire/ — BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for vosoritide, an investigational, once daily injection analog of C-type

Treatment for Postoperative Pain Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain SAN DIEGO, Nov. 13, 2020 /PRNewswire/ – Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced

sutimlimab Treatment for Cold Agglutinin Disease (CAD) FDA Issues Complete Response Letter for Sutimlimab, an Investigational Treatment for Hemolysis in Adults with Cold Agglutinin Disease PARIS – November 13, 2020 - The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for

KENILWORTH, N.J.–(BUSINESS WIRE) November 13, 2020 — Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose

6 November 2020 — AstraZeneca’s Brilinta (ticagrelor) has been approved in the US to reduce the risk of stroke, a leading cause of disability and death worldwide, in patients with acute ischemic stroke (National Institutes of Health Stroke Scale score ≤5) or high-risk transient ischaemic attack (TIA). The approval by the US Food and Drug Administration (FDA)

ibrexafungerp Treatment for Vaginal Candidiasis Scynexis Announces Submission of New Drug Application to the U.S. Food and Drug Administration for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infection JERSEY CITY, N.J., Oct. 14, 2020 (GLOBE NEWSWIRE) — SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections,

FDA Approves Sutab (sodium sulfate, magnesium sulfate, and potassium chloride) Tablets for Colonoscopy Preparation BRAINTREE, Mass., Nov. 10, 2020 /PRNewswire/ — Sebela Pharmaceuticals® today announces that the U.S. Food and Drug Administration (FDA) approved Sutab® (sodium sulfate, magnesium sulfate, and potassium chloride) tablets. Sutab, a sulfate-based tablet preparation for colonoscopy, was developed and will be

Treatment for Migraine Zosano Pharma Receives Complete Response Letter from FDA for Qtrypta FREMONT, Calif., Oct. 21, 2020 (GLOBE NEWSWIRE) – Zosano Pharma Corporation (NASDAQ:ZSAN), a clinical-stage biopharmaceutical company, announced today that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in connection with the Qtrypta™ (zolmitriptan transdermal microneedle system) 505(b)(2) New Drug Application

November 9, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy November 09, 2020 — Lohxa, LLC is voluntarily recalling Chlorhexidine Gluconate Oral Rinse USP, 0.12% Alcohol free (NDC:70166-027-15) products bearing an expiration date from 01/31/21 – 03/31/21 (see specific lots below) to the consumer level. This product is sourced and repackaged from Sunstar Americas Inc. who