Michael B. Gerhardt, MD, is a sports medicine specialist and orthopedic surgeon at Cedars-Sinai Kerlan-Jobe Institute in Los Angeles and team physician for the LA Galaxy and U.S. Soccer Men's National Team.

Here are 10 must-read Q&As from 2018 on biologics.

Robert LaPrade, MD, is an orthopedic surgeon based in Colorado.

The FDA warned Genetech and its president Edwin Pinos for manufacturing stem cell products without FDA approval and deviating from current good manufacturing practice requirements, which may have led to microbial contamination.

The FDA recently vowed to crackdown on unsubstantiated and poor quality stem cell therapies in 2019. Biologic-based products and other emerging medical technologies are at the center of a debate over the best regulatory pathways to ensure patient safety.

A U.S. nonprofit organization found Biogen Inc's Spinraza treatment for spinal muscular atrophy and Novartis AG's experimental gene therapy are both expensive but have the potential to be more cost effective with additional research, according to Reuters.

The first patient was enrolled in CartiHeal’s Agili-C implant investigational device exemption pivotal study at The Ohio State University Wexner Medical Center in Columbus.

Regenerative medicine company BioRez moved into its new office, research and technology space in New Haven, Conn.

James Bicos, MD, of Michigan Orthopaedic Surgeons in Bingham Farms, is a sports medicine and shoulder surgeon who has focused his career on procedures such as shoulder reconstructions, cartilage restoration, stem cell injections and meniscal transplants.

Alpesh Patel, MD, director of the spine surgery fellowship and co-director of the Northwestern Spine Center in Chicago, discusses the key trends for orthopedics in 2019 and where he sees the biggest opportunity for growth.

Alejandro Badia, MD, is using the BioPro Modular Thumb Implant to treat basal joint arthritis.

MTF Biologics awarded 10 researchers more than $1.6 million in funding through its 2018 Research Grant Program.

The California Institute for Regenerative Medicine in Oakland awarded a $5.6 million research grant to UC Davis Health researchers Diana Farmer, MD, and Aijun Wang, PhD, for their work on stem cell therapies for spina bifida.

In 2018, Kuros Biosciences recorded the first sales of its MagnetOs bone graft substitute in the U.S. and Europe and raised capital to fund a phase 2 clinical trial of its spinal fusion product.

Sharonville, Ohio-based Beacon Orthopaedics & Sports Medicine is offering orthobiologic and regenerative medicine treatment options for patients with neck and spine pain, Fox19.com reports.

Royal Biologics is an orthobiologics company focused on regenerative cellular technology.

The FDA plans to crackdown on unsubstantiated and poor quality stem cell therapies in 2019, Law 360 reports.

Axolotl Biologix released the Axolotl Shot, a syringe preloaded with ambient temperature regenerative fluid that physicians can apply to patients during same-day, outpatient visits.

Dakota Dunes, S.D.-based Center for Neurosciences, Orthopaedics & Spine physicians have used platelet rich plasma injections to treat more than 100 joint pain patients, according to KTIV News.

The Japanese Pharmaceuticals and Medical Devices Agency granted DiscGenics approval for a clinical trial notification application for its IDCT, an allogeneic, injectable disc cell therapy for degenerative disc disease.