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2854 News Found

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets
Drug Approval | October 03, 2024

Alembic Pharmaceuticals receives USFDA final approval for Lamotrigine Extended-Release Tablets

Lamotrigine extended-release tablets are indicated for adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures


Chemify gets grant to design and discover new drug leads for Tuberculosis and Malaria
Digitisation | October 03, 2024

Chemify gets grant to design and discover new drug leads for Tuberculosis and Malaria

Grant funding from the Bill & Melinda Gates Foundation will support the rapid and efficient design and synthesis of novel small molecules


Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir
News | October 02, 2024

Dr. Reddy’s signs licensing agreement with Gilead Sciences to manufacture and commercialise Lenacapavir

Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022


Apitoria Pharma gets Form 483 with 10 observations from USFDA
Drug Approval | October 01, 2024

Apitoria Pharma gets Form 483 with 10 observations from USFDA

The observations are of procedural in nature and will be responded to within the stipulated time


USFDA inspection update on Jubilant HollisterStier’s Montreal facility
Drug Approval | September 30, 2024

USFDA inspection update on Jubilant HollisterStier’s Montreal facility

HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures


Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma
Drug Approval | September 29, 2024

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations


AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin
Drug Approval | September 28, 2024

AbbVie submits Biologics license application to USFDA for Telisotuzumab Vedotin

Teliso-V is an investigational antibody-drug conjugate (ADC) for patients with previously treated nonsquamous non-small cell lung cancer (NSCLC) with c-Met protein overexpression


FDA approves Bristol Myers Squibb’s Cobenfy
Drug Approval | September 28, 2024

FDA approves Bristol Myers Squibb’s Cobenfy

A first-in-class muscarinic agonist for the treatment of schizophrenia in adults