SPARC announces submission of IND application for SBO-154 to USFDA
SBO-154 set to enter global Phase 1 clinical trial for treatment of advanced solid tumours
Sign in
Sign in
Recover your password.
A password will be e-mailed to you.
Browsing Category
Drug approvals
FDA drug approvals drop 15.44%, but smaller pharma leads innovation: GlobalData
GlobalData’s bio/pharmaceutical outsourcing report highlights the reliance of smaller pharma companies on CDMOs for production,…
Lilly launches Mounjaro (tirzepatide), offers new treatment option for obesity and type 2 diabetes
Phase 3 SURPASS programme demonstrated that Mounjaro, whether used alone or with other diabetes medications, reduced A1C by up to…
Lupin gains tentative USFDA approval for Amifampridine Tablets
Amifampridine Tablets, 10 mg, are bioequivalent to Firdapse Tablets, 10 mg of Catalyst Pharmaceuticals
Zydus receives final USFDA approval for Eluxadoline Tablets, 75 mg and 100 mg
Eluxadoline is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhoea…
Zydus receives final USFDA approval for Ketoconazole Shampoo, 2%
Ketoconazole shampoo is an antifungal medication used to treat dandruff, fungal infections, and other skin conditions
AstraZeneca gains CDSCO approval to import SZC for treating Hyperkalaemia in adult patients
This treatment can enhance hyperkalaemia management in adults, a condition characterised by elevated potassium levels that often…
Lerodalcibep can be a treatment option for patients requiring additional LDL-C reduction: GlobalData
Lerodalcibep is a novel therapy designed to lower low-density lipoprotein cholesterol (LDL-C) in patients with atherosclerotic…
Glenmark USA acquires and launches Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose…
Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA
USFDA classifies inspection at Dr Reddy’s API facility as Voluntary Action Indicated
Dr Reddy’s Laboratories receives Establishment Inspection Report for its API manufacturing facility in Bollaram, Hyderabad
Lupin receives U.S. FDA approval for generic Ipratropium Bromide nasal spray
Approval allows marketing of generic equivalent of Atrovent Nasal Spray in the U.S.
Lupin and Natco secure US FDA approval for generic Bosentan tablets for oral suspension
Natco receives first-to-file exclusivity for Bosentan Tablets for Oral Suspension, 32 mg, in the US market
Lupin receives tentative FDA approval for generic Darunavir combination tablets
It will be manufactured at Lupin’s Nagpur facility in India
USFDA approves novel non-opioid treatment for moderate to severe acute pain
Vertex Pharmaceuticals’ Journavx is the first drug to be approved in this new class of pain management medicines
Novo Nordisk’s Ozempic gains USFDA approves to cut risk of diabetic kidney disease progression
The approval was based on data from a late-stage study, which showed that Ozempic helped cut the risk of death from chronic kidney…
Lupin gains USFDA approval for Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension
The fixed-dose combination is indicated for the treatment of HIV-1 infection in pediatric patients aged at least 3 months and…
USFDA lifts clinical hold on Opella’s planned actual use trial to switch Cialis from prescription to…
Cialis (tadalafil) in the US is currently only available with a prescription. Cialis is a tablet taken to treat erectile…
Strides gains USFDA approval for Acetaminophen and Ibuprofen Tablets, 125 mg /250 mg
The product is bioequivalent to the reference listed drug (RLD), Advil Dual Action with Acetaminophen, 125 mg /250 mg (OTC), of…
CDSCO approves AstraZeneca’s anti-complement medicine Eculizumab
Eculizumab is approved in India to manage two rare diseases- Paroxysmal Nocturnal Hemoglobinuria (PNH) and atypical Hemolytic…
Alembic Pharma gets USFDA final approval for Brexpiprazole Tablets, 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3…
Brexpiprazole is an atypical antipsychotic used as an adjunctive therapy to antidepressants for the treatment of major depressive…