Drugs

Treatment for Opioid Overdose Adamis Provides Update on Zimhi SAN DIEGO, June 09, 2021 (GLOBE NEWSWIRE) – Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s resubmitted New Drug Application (NDA) for ZIMHI™, which is its higher naloxone injection product candidate for the treatment of opioid overdose. Adamis received
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FDA Approves Rezipres (ephedrine hydrochloride injection) for Hypotension During Anesthesia DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) — Eton Pharmaceuticals, Inc (Nasdaq: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres (ephedrine hydrochloride injection) for the treatment of clinically important hypotension occurring in the setting of anesthesia. “We are
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ruxolitinib Treatment for Atopic Dermatitis, Vitiligo Incyte Announces U.S. FDA Has Extended the New Drug Application Review Period for Ruxolitinib Cream for the Treatment of Atopic Dermatitis WILMINGTON, Del.–(BUSINESS WIRE) June 11, 2021 — Incyte Corporation (Nasdaq:INCY) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the New
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BOSTON–(BUSINESS WIRE)–Jun. 7, 2021– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Ultomiris (ravulizumab-cwvz) to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria (PNH). Ultomiris, a long-acting C5 inhibitor that offers immediate, complete and sustained complement inhibition, is now the first and only
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FOSTER CITY, Calif.–(BUSINESS WIRE)–Jun. 10, 2021– Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for the treatment of chronic hepatitis C virus (HCV) to now include children as young as 3 years of age, regardless of HCV
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June 11, 2021 Audience:  Patient, Health Professional, Pharmacy  Viona Pharmaceuticals Inc., is voluntarily recalling 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg to the retail level. The 2 (two) lots of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg have been found to contain levels of Nitrosodimethylamine (NDMA) impurities above acceptable daily limits.
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BOSTON, June 01, 2021 (GLOBE NEWSWIRE) — Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and for other public health threats for civilian, government and military use, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s
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EAST HANOVER, N.J., June 1, 2021 /PRNewswire/ — Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe plaque psoriasis in pediatric patients six years and older who are candidates for systemic therapy or phototherapy1. This is the
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FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and deaths in the U.S. Helps protect against more serotypes
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BOSTON–(BUSINESS WIRE)–Jun. 9, 2021– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages 6 through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a
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FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1 LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”) announced today that the U.S. Food & Drug Administration (FDA) has approved Ryplazim (plasminogen, human-tvmh) (“Ryplazim”) for the treatment of patients
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FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer’s Disease CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) — Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™ (aducanumab-avwa) as the first and only Alzheimer’s
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FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) — Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Tembexa (brincidofovir) tablets and oral suspension approval
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Treatment for Prevention of Cisplatin-Induced Ototoxicity Fennec Pharmaceuticals Resubmits New Drug Application To U.S. Food And Drug Administration For Pedmark Research Triangle Park, NC, May 28, 2021 – Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a specialty pharmaceutical company, today announced the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug
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oteseconazole Treatment for Vaginal Candidiasis Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA for Oteseconazole for the Treatment of Recurrent Vulvovaginal Candidiasis DURHAM, N.C.–(BUSINESS WIRE) June 01, 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
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FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the first-and-only prescription weight-loss medication with once-weekly dosing. Wegovy™ is used with a reduced calorie meal plan and
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vadadustat Treatment for Anemia Associated with Chronic Renal Failure Akebia and Otsuka Announce FDA Acceptance for Filing of New Drug Application for Vadadustat for the Treatment of Anemia Due to Chronic Kidney Disease in Adult Patients on Dialysis and Not on Dialysis CAMBRIDGE, Mass. and TOKYO, June 1, 2021 /PRNewswire/ – Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with
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PRINCETON, N.J.–(BUSINESS WIRE) May 27, 2021 — Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD).1 Zeposia, an oral medication taken once daily, is the first
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pacritinib Treatment for Myelofibrosis CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis SEATTLE, June 1, 2021 /PRNewswire/ – CTI BioPharma Corp. (Nasdaq: CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia
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FDA Approves Brexafemme (ibrexafungerp) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) — Scynexis, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) has
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FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder DUBLIN, June 1, 2021 /PRNewswire/ — Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with
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FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) — BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved Truseltiq (infigratinib) under the accelerated approval program for
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FDA Approves Pylarify (piflufolastat F 18) PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer May 27, 2021 — FDA has approved Pylarify (piflufolastat F 18) – a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify, certain men with prostate
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FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell
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FDA Approves Camcevi (leuprolide mesylate) for the Treatment of Advanced Prostate Cancer TAIPEI, May 26, 2021 /PRNewswire/ — Foresee Pharmaceuticals (6576.TWO), (“Foresee”) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Camcevi 42 mg, a ready-to-use 6-month subcutaneous depot formulation of leuprolide mesylate, as a treatment
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May 26, 2021 Audience: Consumer May 26, 2021 — Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the Federal Food, Drug, and Cosmetic
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FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Myfembree (relugolix 40 mg, estradiol 1 mg,
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