Zydus Lifesciences receives U.S. FDA approval for Scopolamine Transdermal System
Zydus gains final approval to market Scopolamine Transdermal System, marking its fifth ANDA approval in the transdermal portfolio…
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Drug approvals
US FDA approves Emergent’s smallpox vaccine for people at high risk of mpox
FDA approves Emergent's ACAM2000 smallpox vaccine for high-risk mpox patients, amid ongoing global health concerns and recent…
Lupin receives U.S. FDA approval for Brimonidine Tartrate Ophthalmic Solution
Lupin to market generic version of AbbVie's Alphagan P for elevated intraocular pressure, manufactured at its Pithampur facility
Sun Pharma introduces STARIZO (Tedizolid Phosphate) in India for ABSSSI
Sun Pharma has obtained rights from MSD to develop, manufacture and commercialise Tedizolid Phosphate in India
Lupin gains Health Canada approval for biosimilar Pegfilgrastim
Pegfilgrastim is a Pegylated form of the recombinant human granulocyte colony-stimulating factor (G-CSF) analogue Filgrastim
Gilead’s Livdelzi wins FDA approval, can challenge Ocaliva dominance in primary biliary cholangitis…
The approval could present a major challenge to Ocaliva (obeticholic acid), which was until recently the sole approved drug for…
FDA approves and authorises updated mRNA COVID-19 vaccines
The mRNA COVID-19 vaccines have been updated with a monovalent component that corresponds to the Omicron variant KP.2 strain…
J&J’s EGFR-mutated advanced lung cancer treatment: amivantamab-vmjw plus lazertinib gains FDA…
The chemotherapy-free regimen showed progression-free survival versus osimertinib
Indoco gains final ANDA approval for Lofexidine Tablets 0.18 mg
Indoco has been granted a CGT designation by the USFDA and being the first approved generic, is eligible for 180 days of CGT…
Granules India receives ANDA approval for Glycopyrrolate Oral Solution
It is bioequivalent and therapeutically equivalent to the reference listed drug, Cuvposa Oral Solution, 1 mg/5 mL of Merz…
US FDA approves AstraZeneca’s non-small cell lung cancer treatment
Imfinzi gains expanded use, and AstraZeneca’s shares rise after a priority review for small cell lung cancer
Atul Bioscience receives US FDA EIR with zero observations for Ambernath facility
Atul Bioscience’s Ambernath manufacturing site earns US FDA approval with zero 483 observations, highlighting the company’s…
Dr Reddy’s Labs gets US FDA clearance: Visakhapatnam facilities classified as VAI
USFDA concludes inspection of Dr Reddy's Visakhapatnam units with Voluntary Action Indicated status
Granules India gains ANDA approval for Trazodone tablets
The current annual US market for Trazodone tablets is approximately $128 million, according to MAT Jun 2024, IQVIA/IMS Health
Zydus gains final USFDA approval for Valbenazine Capsules
Valbenazine Capsules had annual sales of $ 1,993.6 million in the United States (IQVIA MAT June 2024)
Novartis’ kidney disease drug Fabhalta receives US FDA approval
Fabhalta specifically targets the alternative complement pathway of the immune system. When overly activated in the kidneys, the…
FDA approves first Nalmefene Hydrochloride auto-injector to reverse opioid overdose
The newly approved product delivers 1.5 milligrams (mg) of nalmefene under the skin (subcutaneous) or into muscle (intramuscular)…
Alembic gains USFDA final approval for Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg
Acitretin Capsules USP, 10 mg, 17.5 mg, and 25 mg have an estimated market size of $ 21 million for twelve months ending June 2024…
Servier’s Voranigo tablets receive FDA approval for brain tumour treatment
VORANIGO demonstrated significant improvement in progression-free survival with a favourable safety profile in a pivotal Phase 3…
Lupin gets USFDA nod for Prednisolone Acetate Ophthalmic Suspension USP
Lupin was granted a Competitive Generic Therapy designation (CGT) for this product, and being the first approved applicant, Lupin…