Indoco Remedies' Baddi plant gets EU GMP approval from Malta Medicines Authority

The certification follows an inspection conducted by the Malta Medicines Authority between January 29, 2026, and February 3, 2026

Alembic Pharma receives USFDA tentative approval for Darolutamide tablets

Darolutamide Tablets, 300 mg, had an estimated market size of US$ 3,155 million in the United States

Pfizer scores landmark EU approval for hemophilia drug HYMPAVZI

The decision marks a significant expansion for Pfizer’s once-weekly injectable therapy

Bristol Myers Squibb wins EU nod for Sotyktu in active psoriatic arthritis

The once-daily oral therapy is the first and only tyrosine kinase 2 (TYK2) inhibitor approved in the European Union for this indication, marking a significant expansion of its immunology portfolio

Venus Remedies gets marketing authorization for Ceftriaxone in Argentina

Approval strengthens the company’s growing international anti-infective portfolio

ADMA Biologics wins FDA nod to expand ASCENIV use in young children

Caplin Steriles receives USFDA approval for Calcium Gluconate Injection

Fresenius Kabi's approved generic therapy addresses acute symptomatic hypocalcemia and targets a US market valued at nearly $71 million

OneSource powers second generic semaglutide nod in Canada

Approval marks the second generic semaglutide clearance in Canada and strengthens OneSource’s position in complex injectable CDMO programs

Lupin receives USFDA approval for generic Ravicti oral liquid

Approval expands Lupin’s specialty portfolio in the US market for treatment of urea cycle disorders

Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility

The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026

Aurobindo arm CuraTeQ receives Health Canada approval for bevacizumab biosimilar Bevqolva

Notice of Compliance from Health Canada enables marketing authorisation for cancer biosimilar in Canadian market

Dr Reddy’s becomes first to secure Health Canada nod for generic Semaglutide injection

Market authorization for generic GLP-1 therapy strengthens company’s diabetes portfolio in Canada

Solara announces closure of US FDA inspection at Puducherry facility

The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets

Wanbury's Patalganga site clears Korea FDA inspection with zero observations

Patalganga plant received zero observation from USFDA earlier

OneSource Pharma, Dr Reddy’s secure Health Canada nod for generic Semaglutide

Approval for generic Semaglutide Injection strengthens CDMO partnership, enabling scalable supply from OneSource’s US FDA-approved Bengaluru facility

AbbVie seeks FDA nod for RINVOQ use in severe alopecia areata

After Phase 3 results show major hair regrowth gains

AbbVie seeks FDA nod for subcutaneous SKYRIZI induction in Crohn’s disease

The submission is backed by positive results from the Phase 3 AFFIRM study

Alembic announces FDA final approval for Fingolimod capsules

The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Gilenya Capsules, 0.5 mg of Novartis Pharmaceuticals Corporation (Novartis)

Cipla wins USFDA nod for first generic of Ventolin HFA strengthening respiratory push

The approval makes Cipla’s product the first AB-rated generic therapeutic equivalent of Ventolin HFA

Cipla’s generic Ventolin HFA secures USFDA approval

Approval for Albuterol Sulfate inhalation aerosol enables Cipla Limited to enter the $1.5 billion U.S. albuterol market