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7852 News Found

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas
Drug Approval | January 19, 2025

Zydus Lifesciences receives approval from USFDA to conduct Phase II(b) clinical trial for Usnoflas

This study will enrol 210 ALS patients and study doses of 50 mg and 75 mg Usnoflast versus placebo


GCPB revokes closure order of Aarti Pharmalabs’s Vapi plant
News | January 19, 2025

GCPB revokes closure order of Aarti Pharmalabs’s Vapi plant

The company has paid an Interim Environmental Damage Compensation of Rs. 3.40 lakh to GPCB


Heraeus acquires Umicore’s Platinum API business outside of South America
News | January 19, 2025

Heraeus acquires Umicore’s Platinum API business outside of South America

The company ensures a reliable and strong portfolio at competitive prices without compromising on excellent quality


Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags
Drug Approval | January 18, 2025

Caplin Steriles gets USFDA approval for Levetiracetam in Sodium Chloride Injection Infusion bags

This is the second Ready-To-Use Infusion bag (RTU Bags) ANDA drug product approved for Caplin Steriles


AstraZeneca receives CDSCO approval to launch eculizumab in India
Drug Approval | January 17, 2025

AstraZeneca receives CDSCO approval to launch eculizumab in India

Eculizumab is indicated for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria and atypical Hemolytic Uremic Syndrome


Sun Pharma to acquire 100% stake in Antibe Therapeutics
Biotech | January 17, 2025

Sun Pharma to acquire 100% stake in Antibe Therapeutics

Antibe Therapeutics is a clinical-stage biotechnological company developing novel drugs primarily focusing on reducing pain and inflammation


AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma
News | January 17, 2025

AbbVie partners with Simcere Zaiming to develop Novel Trispecific Antibody Candidate in Multiple Myeloma

SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3


FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA
Drug Approval | January 17, 2025

FDA issues five observations to Jubilant Pharmova’s Salisbury facility in USA

Jubilant Cadista will submit an appropriate action plan to the USFDA on these observations


Alembic announces USFDA final approval for Brexpiprazole Tablets
Drug Approval | January 16, 2025

Alembic announces USFDA final approval for Brexpiprazole Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets


Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby
News | January 16, 2025

Briefs: Morepen Laboratories, Glenmark Life Sciences, Gland Pharma and Shalby

Morepen Laboratories approves hiving off of medical devices business