Drugs

Treatment for Pharmacologic Mydriasis Eyenovia Submits New Drug Application to FDA for Pharmacologic Mydriasis with MydCombi NEW YORK–(BUSINESS WIRE)–Dec. 29, 2020– Eyenovia, Inc. (NASDAQ: EYEN), a clinical stage ophthalmic biopharmaceutical company with Phase 3 programs in presbyopia, myopia and mydriasis, today announced that it has submitted a New Drug Application (NDA) to the U. S. Food and Drug

December 18, 2020 — Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Iclusig (ponatinib) for adult patients with chronic-phase (CP) chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors. The updated label includes

Treatment for Schizophrenia, Bipolar Disorder FDA Accepts Alkermes’ Resubmission of New Drug Application for ALKS 3831 DUBLIN, Dec. 29, 2020 /PRNewswire/ – Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the company’s New Drug Application (NDA) resubmission for ALKS 3831 (olanzapine/samidorphan) for the treatment of adults with schizophrenia and adults with

December 28, 2020 Audience: Consumer, Patient, Health Professional, Pharmacy Schaumburg, Illinois, Sunstar Americas, Inc. (SAI) is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products bearing an expiration date from 12/31/2020 – 9/30/2022 to the consumer level. This product may be contaminated with the bacteria Burkholderia lata. This is an expansion of the recall

FDA Approves Gemtesa (vibegron) Tablets for the Treatment of Patients with Overactive Bladder (OAB) IRVINE, Calif. & BASEL, Switzerland–(BUSINESS WIRE)–Dec. 23, 2020– Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg Gemtesa (vibegron), a beta-3 adrenergic receptor (β3) agonist,

December 23, 2020 Audience: Consumers December 23, 2020 — Shane Erickson, Inc. is voluntarily recalling lot 2020/05/11 and MFG: 2020/05/10 L/N: 20200510-3 of imc Wash-Free Hand Sanitizer 50 ml, 100 ml, 300 ml and Wash Free Hand Sanitizer 300 ml lot 2020/05/11 and Thrifty White Pharmacy Wash-Free Hand Sanitizer 300 ml lot 2020/05/11 listed in

FDA Approves Riabni (rituximab-arrx), a Biosimilar to Rituxan THOUSAND OAKS, Calif., Dec. 17, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Riabni (rituximab-arrx), a biosimilar to Rituxan® (rituximab), for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA)

NEWTON, Mass., Dec. 18, 2020 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved Xpovio (selinexor), the Company’s first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib and dexamethasone for the treatment

FDA Approves Ebanga (ansuvimab-zykl) for the Treatment of Zaire Ebolavirus Infection December 21, 2020 — The U.S. Food and Drug Administration approved Ebanga (Ansuvimab-zykl), a human monoclonal antibody, for the treatment for Zaire ebolavirus (Ebolavirus) infection in adults and children. Ebanga blocks binding of the virus to the cell receptor, preventing its entry into the

21 December 2020 — AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 L858R mutations as detected by an

FDA Approves Orgovyx (relugolix) as the First Oral Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist for Advanced Prostate Cancer BASEL, Switzerland, Dec. 18, 2020 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the U.S. Food and Drug Administration (FDA) has approved Orgovyx (relugolix)

infigratinib Treatment for Cholangiocarcinoma of biliary tract BridgeBio Pharma And Affiliate QED Therapeutics Announce FDA Acceptance Of New Drug Application For Infigratinib For The Treatment Of Cholangiocarcinoma PALO ALTO, CA – December 1, 2020 – BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with

ublituximab Treatment for Chronic Lymphocytic Leukemia TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia NEW YORK, Dec. 01, 2020 (GLOBE NEWSWIRE) – TG Therapeutics, Inc. (NASDAQ: TGTX) today announced that the Company has initiated a rolling submission

South San Francisco, CA — December 14, 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 shorter two-hour infusion time for Ocrevus® (ocrelizumab), dosed twice-yearly for those living with relapsing or primary progressive multiple sclerosis (MS) who have

amivantamab Treatment for Non-Small Cell Lung Cancer Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations RARITAN, N.J., December 3, 2020 – The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the submission of a Biologics License

FDA Approves Margenza (margetuximab-cmkb) for Patients with Pretreated Metastatic HER2-Positive Breast Cancer ROCKVILLE, MD, Dec. 16, 2020 (GLOBE NEWSWIRE) —  MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved Margenza, in

Treatment for Eosinophilic Esophagitis U.S. Food and Drug Administration Accepts New Drug Application for Review, Grants Priority Review for Takeda’s TAK-721 (budesonide oral suspension) for the Treatment of Eosinophilic Esophagitis Osaka, JAPAN, December 15, 2020 – Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced that the United States (U.S.) Food and Drug Administration (FDA) has accepted

FDA Approves Klisyri (tirbanibulin) for the Treatment of Actinic Keratosis on the Face or Scalp BUFFALO, N.Y., Dec. 15, 2020 (GLOBE NEWSWIRE) — Athenex, Inc., (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer and related conditions, today announced that the U.S. Food

brincidofovir Treatment for Smallpox Chimerix Announces FDA Acceptance of New Drug Application for Brincidofovir as a Medical Countermeasure for Smallpox DURHAM, N.C., Dec. 07, 2020 (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 accepted the

ibrexafungerp Treatment for Vaginal Candidiasis Scynexis Announces FDA Acceptance and Priority Review of New Drug Application for Oral Ibrexafungerp for the Treatment of Vaginal Yeast Infections JERSEY CITY, N.J., Dec. 07, 2020 (GLOBE NEWSWIRE) – SCYNEXIS, Inc.,  (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that the

Treatment for Congestive Heart Failure scPharmaceuticals Inc. Receives Complete Response Letter from FDA for Furoscix BURLINGTON, Mass., Dec. 07, 2020 (GLOBE NEWSWIRE) — 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 patient care, and reduce healthcare costs, today

Treatment for Acne Sol-Gel Technologies Announces FDA Acceptance for Filing of New Drug Application for Twyneo for the Treatment of Acne Vulgaris NESS ZIONA, Israel, Dec. 07, 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 products for the treatment of skin diseases, today announced

WASHINGTON, Dec. 1, 2020 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the U.S. Food and Drug Administration (FDA) has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with nighttime sleep disturbances associated with Smith-Magenis Syndrome (SMS). SMS is a rare neurodevelopmental disorder, a defining

Treatment for Hypogonadism — Male Lipocine Announces Tentative Approval of TLANDO SALT LAKE CITY, Dec. 8, 2020 /PRNewswire/ — Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, today announced that the U.S. Food and Drug Administration (“FDA”) has granted tentative approval to TLANDO, its oral testosterone product for testosterone replacement therapy (“TRT”)

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 the company’s supplemental Biologics License Application (sBLA) for Xolair ® (omalizumab) for the add-on maintenance treatment of nasal polyps in adult patients 18 years of

December 9, 2020 Audience: Consumer, Health Professional, Pharmacy December 9, 2020 — Torrent Pharmaceuticals Limited is voluntarily recalling one lot of Anagrelide Capsules, USP to the consumer level due to dissolution test failure detected during routine quality testing. Failed dissolution can result in a slower rate and extent of drug release leading to less anagrelide

odevixibat Treatment for Progressive Familial Intrahepatic Cholestasis (PFIC) Albireo Submits for U.S. FDA and EMA Product Approval of Once-Daily Odevixibat for PFIC BOSTON, Dec. 08, 2020 (GLOBE NEWSWIRE) – Albireo Pharma, Inc. (Nasdaq: ALBO), a clinical-stage rare liver disease company developing novel bile acid modulators, today announced it has submitted a New Drug Application (NDA) to the U.S. Food and

FDA Approves Gallium 68 PSMA-11 as the First PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer December 01, 2020 — Today, the U.S. Food and Drug Administration approved Gallium 68 PSMA-11 (Ga 68 PSMA-11) – the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with