Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s New Drug Application...
https://www.med-chemist.com/2024/10/fda-approves-tepylute-thiotepa-ready-to.html
Verona Pharma plc (Nasdaq: VRNA) (“Verona Pharma” or the “Company”), announces the US Food and Drug Administration (“FDA”) approved Ohtuvayre (ensifentrine) for the maintenance trea...
https://www.med-chemist.com/2024/10/fda-approves-ohtuvayre-ensifentrine-for.html
Clinical dermatology company, Botanix Pharmaceuticals Ltd. (ASX:BOT, Botanix or the Company), is pleased to announce the US Food and Drug Administration (FDA) approval of Sofdra™ (sofpironium)...
https://www.med-chemist.com/2024/10/fda-approves-sofdra-sofpironium-topical.html
Pyros Pharmaceuticals, Inc. (Pyros or the Company), a leader in the development of enhanced specialty pharmaceuticals for rare diseases, announced today that the U.S. Food and Drug Administration...
https://www.med-chemist.com/2024/10/fda-approves-vigafyde-vigabatrin-as.html
Ipsen (Euronext: IPN; ADR: IPSEY) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Iqirvo (elafibranor) 80 mg tablets for the treatment of p...
https://www.med-chemist.com/2024/10/fda-grants-accelerated-approval-to.html
Lumicell, Inc., a privately held company focused on developing innovative fluorescence-guided imaging technologies for cancerous tissue detection during surgery, today announced the U.S. Food & D...
https://www.med-chemist.com/2024/10/fda-approves-lumisight-pegulicianine.html
The U.S. Food and Drug Administration (FDA) has approved Xromi, an oral solution formulation of hydroxyurea indicated to reduce the frequency of painful crises and reduce the need for blood tr...
https://www.med-chemist.com/2024/10/fda-approves-xromi-hydroxyurea-oral.html
Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, today announced that the U.S. Food and Drug Admin...
https://www.med-chemist.com/2024/09/fda-approves-rytelo-imetelstat-for.html
Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies f...
https://www.med-chemist.com/2024/09/fda-grants-accelerated-approval-for_0541614428.html
Tris Pharma, Inc. (Tris), a commercial-stage biopharmaceutical company focused on attention deficit hyperactivity disorder (ADHD), pain, addiction and neurological disorders, today announced the ...
https://www.med-chemist.com/2024/09/fda-approves-onyda-xr-clonidine.html
Today, Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorized the marketing of Risvan® (Risperido...
https://www.med-chemist.com/2024/09/fda-approves-risvan-risperidone-for.html
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced to...
https://www.med-chemist.com/2024/09/fda-approves-zevtera-ceftobiprole.html
Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the...
https://www.med-chemist.com/2024/09/fda-approves-myhibbin-mycophenolate.html
Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovat...
https://www.med-chemist.com/2024/09/fda-approves-libervant-diazepam-buccal.html
Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible i...
https://www.med-chemist.com/2024/09/fda-approves-pivya-pivmecillinam-for.html
Voydeya (danicopan) has been approved in the US as an add-on therapy to eculizumab or eculizumab for the treatment of extravascular hemolysis (EVH) in adults with paroxysmal nocturnal hemoglobin...
https://www.med-chemist.com/2024/09/fda-approves-voydeya-danicopan-as-add.html
Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Admini...
https://www.med-chemist.com/2024/09/fda-approves-vafseo-vadadustat-for.html
Italfarmaco S.p.A. announced today that the U.S. Food and Drug Administration (FDA) has approved Duvyzat™ (givinostat), a novel histone deacetylase (HDAC) inhibitor, for the treatment of pa...
https://www.med-chemist.com/2024/09/fda-approves-duvyzat-givinostat-for.html
Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved Opsynvi® – a single-tablet combination of macitentan, an endothelin receptor antagonist (ERA),...
https://www.med-chemist.com/2024/09/fda-approves-opsynvi-macitentan-and.html
The U.S. Food and Drug Administration has approved Rezenopy (naloxone hydrochloride) nasal spray 10 mg for emergency treatment of known or suspected opioid overdose, as manifested by respirator...
https://www.med-chemist.com/2024/09/fda-approves-rezenopy-naloxone.html
Idorsia Pharmaceuticals U.S. Inc. announced the US Food and Drug Administration (FDA) approval of Tryvio™ (aprocitentan) for the treatment of hypertension in combination with other antihype...
https://www.med-chemist.com/2024/09/fda-approves-tryvio-aprocitentan-for.html
Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), announced the U.S. Food and Drug Admi...
https://www.med-chemist.com/2024/09/fda-grants-accelerated-approval-for.html
X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare diseases of the immune system, today announced that the U.S. Food and Drug Administration (FDA) has ap...
https://www.med-chemist.com/2024/09/fda-approves-xolremdi-mavorixafor-for.html
Allecra Therapeutics (“Allecra”), a biopharmaceutical company developing novel therapies to combat antibiotic resistance, announced today that the U.S. Food and Drug Administration (F...
https://www.med-chemist.com/2024/09/fda-approves-exblifep.html
Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved Fruzaqla ™ (fruquintinib), an oral targeted therapy for adults with metastatic colorect...
https://www.med-chemist.com/2024/09/fda-approves-fruzaqla-fruquintinib-for_01548910670.html