Conduit Pharmaceuticals successfully completed Phase I of its strategic collaboration with Sarborg Limited, establishing foundations for AI integration in drug development processes.

Alembic Pharmaceuticals secured USFDA approval for Diltiazem Hydrochloride Extended-Release Capsules (120-360 mg).

Algorae Pharmaceuticals has launched a new artificial intelligence (AI) platform to enhance its drug development processes, aiming to accelerate research and improve outcomes.

Alembic Pharmaceuticals has secured USFDA approval for its generic Diltiazem Hydrochloride extended-release capsules, used to treat hypertension.

Corbus Pharmaceuticals has dosed the first patient in a Phase 1 clinical trial of CRB-601, a novel immunotherapy for advanced solid tumors.

The FDA has placed a clinical hold on CASI Pharmaceuticals' CID-103, an anti-CD38 monoclonal antibody, halting its clinical trial.

Lipella Pharmaceuticals has re-signed its manufacturing collaboration agreement with Cook MyoSite to support Chemistry, Manufacturing and Control documentation for clinical products LP-10 and LP-310.

Acadia Pharmaceuticals has appointed Allyson McMillan-Youngblood as Senior Vice President, Rare Disease Franchise, bringing over 20 years of pharmaceutical industry experience.

Odronextamab, an investigational CD20xCD3 bispecific antibody developed by Regeneron Pharmaceuticals, Inc., is under review by the FDA for treating relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. Despite a Biologics License Application submission and receiving Orphan Drug and Fast Track Designations, the FDA has issued Complete Response Letters due to enrollment status issues in confirmatory trials, without identifying concerns over the drug's efficacy, safety, or manufacturing.

Glenmark Pharmaceuticals Inc., USA has introduced Clindamycin Phosphate Foam 1%, a bioequivalent generic version of Evoclin® Foam, expanding their dermatology portfolio.

Bausch Health Companies Inc. and Mylan Pharmaceuticals have reached a settlement agreement resolving their patent litigation over generic versions of irritable bowel syndrome (IBS) medications.

The FDA has approved ROXYBOND™ (oxycodone hydrochloride) 10 mg immediate-release tablets from Protega Pharmaceuticals for managing severe pain.

ANI Pharmaceuticals has launched Estradiol Gel, 0.06%, after receiving final FDA approval for its Abbreviated New Drug Application, expanding its product portfolio.

Recce Pharmaceuticals has received ethics approval in Indonesia to begin a Phase III trial of RECCE 327 (R327G) topical gel for diabetic foot infections (DFI).

Recursion Pharmaceuticals has initiated a Phase 2 clinical trial for REC-3964, a novel oral treatment for recurrent Clostridioides difficile infection, marking a significant step in addressing a condition that affects up to 175,000 individuals annually in the U.S.

• The global market for breakthrough therapies is projected to grow from $150.6 billion in 2024 to $287.5 billion by 2029, representing a compound annual growth rate of 13.8%. • Expedited regulatory pathways, including the FDA's Breakthrough Therapy Designation and EMA's PRIME scheme, are accelerating development of innovative treatments for serious conditions like cancer and cardiovascular disease. • Recent success stories include AbbVie's epcoritamab for follicular lymphoma and Merck's sotatercept-csrk (WINREVAIR) for pulmonary arterial hypertension, both receiving breakthrough designations.

EyePoint Pharmaceuticals has dosed the first patient in the Phase 3 LUGANO trial of Duravyu for wet age-related macular degeneration (AMD).

Ventyx Biosciences advances VTX3232 into Phase 2 trials for early Parkinson's and obesity, expecting topline results in H1 and H2 2025, respectively.

Madrigal Pharmaceuticals reports $62.2 million in net sales for Rezdiffra™ in Q3 2024, marking a strong initial uptake in the U.S. market.

Madrigal Pharmaceuticals reported $62.2 million in net sales for Rezdiffra in Q3 2024, marking a strong initial uptake in the U.S. market.