Med-Chemist

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